Congressional Testimony
Congressional Testimony
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Biotechnology Innovation Organization President Crowley Testifies Before Senate Health, Education, Labor & Pensions Committee
WASHINGTON, Nov. 14 -- The Senate Health, Education, Labor and Pensions Committee released the following testimony by John F. Crowley, president and CEO of the Biotechnology Innovation Organization, from an Oct. 29, 2025, hearing entitled "The Future of Biotech: Maintaining U.S. Competitiveness and Delivering Lifesaving Cures to Patients":* * *
Chairman Cassidy, Ranking Member Sanders, and distinguished Members of the Committee:
Thank you for the opportunity to appear before you today on behalf of the Biotechnology Innovation Organization (BIO), which represents more than 1,000 biotechnology ... Show Full Article WASHINGTON, Nov. 14 -- The Senate Health, Education, Labor and Pensions Committee released the following testimony by John F. Crowley, president and CEO of the Biotechnology Innovation Organization, from an Oct. 29, 2025, hearing entitled "The Future of Biotech: Maintaining U.S. Competitiveness and Delivering Lifesaving Cures to Patients": * * * Chairman Cassidy, Ranking Member Sanders, and distinguished Members of the Committee: Thank you for the opportunity to appear before you today on behalf of the Biotechnology Innovation Organization (BIO), which represents more than 1,000 biotechnologycompanies, academic institutions, and research centers across the United States.
I am John Crowley, President and CEO of BIO. For me, the future of biotech and delivering lifesaving cures to patients isn't just professional -- it's deeply personal.
Twenty-five years ago, my two youngest children, Megan and Patrick, were diagnosed with Pompe disease, a rare and fatal neuromuscular disorder. At the time, there was no treatment -- no hope beyond comfort care. I left my job, went back to graduate school, and eventually helped start a small biotech company dedicated to developing an enzyme replacement therapy.
That therapy -- born from the ingenuity and perseverance of American scientists, and approved by the FDA -- gave my children a chance at life. Today, Megan and Patrick are living full, meaningful lives.
That experience taught me two things I will never forget: first, that science can save lives, and second, the biotech ecosystem is complex, interdependent, and each piece is critical for success.
So when I speak today about America's biotechnology ecosystem and our global competitiveness, I speak not only as a CEO, but as a father who owes everything to innovation and the people who make it possible.
BIO's members are developing new medicines, vaccines and technologies that improve and save American lives. Biotechnology not only strengthens our nation's health, and is a key driver for the U.S. economy, but is also critical for our national security. We are deeply committed to ensuring that the Food and Drug Administration (FDA) remains the global gold standard for medical product regulation -- protecting public health while ensuring that patients have timely access to safe and effective treatments, but also that the United States maintains its global dominance in biotechnology.
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The Current Biotech Landscape
Nearly 50 years ago, the biotechnology industry was born in the United States with groundbreaking discoveries by American companies, including the development of synthetic insulin. Today, this sector generates over $3 trillion in annual economic output, employs nearly 2.3 million Americans, and supports 8 million additional jobs across the country./1
At the heart of this economic strength is a uniquely innovation-driven ecosystem: approximately 76% of all new medicines originate in small, start-up biotech companies./2
These early-stage innovators take on extraordinary scientific and financial risk - often long before larger partners or investors come on board. Their ability to translate scientific discovery into medical breakthroughs drives progress in global health - and in turn, fuels the economic growth, job creation, and regional development that define the U.S. biotech sector.
And this leadership is national in scope. While hubs like Cambridge, MA, and California are widely recognized, the biotech sector is thriving in every region - from the fast-growing biosciences industries in Texas and Ohio to research hubs in Missouri, Connecticut, and Arkansas. Building on this broad geographic footprint is essential to maintaining our momentum.
Yet the pathway from scientific discovery to approved therapy is long and uncertain. Biotech R&D faces a failure rate exceeding 90%, takes 10-15 years, and can cost more than $2.6 billion./3
Investors will not fund this work unless developers can rely on a predictable environment that includes strong intellectual property (IP) protections, clear regulatory pathways and access to capital.
This challenge is compounded by growing global competition. Maintaining America's dominance in biotechnology is now a national security imperative, particularly in the face of aggressive efforts by China to dominate global health technologies. The bipartisan National Security Commission on Emerging Biotechnology (NSCEB) has warned that China is rapidly closing the innovation gap and may soon overtake the United States as the global leader./4
The numbers are telling: as of March 2025, China accounts for 30% of global clinical trial starts, nearly matching the U.S. share of 35%./5
In 2024, China's innovative drug assets represented 32% of the global pipeline, up from just 4% a decade earlier, according to data from Citeline's Pharmaprojects database./6
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1 BIO and TECONOMY. The U.S. Bioscience Economy: Driving Economic Growth and Opportunity in States and Regions. December 2024.
2 Data analyzed from Biomedtracker.
3 Pharmaceutical Research and Manufacturers of America. Innovation in Biopharmaceuticals. Washington, DC: PhRMA; 2021. https://cdn.aglty.io/phrma/global/resources/import/pdfs/Innovation_in_Biopharmaceuticals.pdf.
4 National Security Commission on Emerging Biotechnology. April 2025. "Charting the Future of Biotechnology: An Action Plan for American Security and Prosperity." https://www.biotech.senate.gov/final-report/chapters/
5 IQVIA Institute for Human Data Science. Global Trends in R&D 2025: Progress in recapturing momentum in biopharma innovation. March 2025. Available from www.iqviainstitute.org biopharma
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Beijing's expanding biotech footprint is not merely economic, it is strategic. China is leveraging its position to manipulate pharmaceutical supply chains, control data flows, and appropriate intellectual property. These actions threaten not only U.S. competitiveness, but also the health security of our allies and trading partners.
To confront these threats and secure America's biotech future, we must take proactive, strategic action. Below I will focus on our urgent opportunities for strengthening the regulatory process through the FDA, spurring innovation through Congressional action and revitalizing the biotechnology manufacturing ecosystem here in the United States. However, securing America's biotech future also includes protecting IP, strengthening trade partnerships, and avoiding policies that undermine access and innovation. These solutions will be essential to unleashing the full power of U.S. biotechnology and ensuring it continues to serve as the global gold standard.
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Strengthening America's Biotech Future: Strategies for Enhancing FDA as Global Gold Standard
The US biotechnology ecosystem depends on the FDA as the global gold standard. Its rigor and integrity underpin public trust in every new medicine. Today, the FDA stands at an inflection point. Under new leadership, and amid rapid scientific and technological change, the Agency has an extraordinary opportunity to harness expertise and modernize its policies and operations to meet the needs of 21st-century innovation.
The FDA's mission has always been dual: to safeguard the public and to enable access to innovation. These are not competing objectives -- they are mutually reinforcing. When FDA's processes are predictable, science-driven, and transparent, patients benefit first. If we are to keep pace with global innovation, the FDA must continue to evolve -- embracing its role as both gatekeeper and catalyst for biomedical progress. We can and must continually modernize the FDA to keep it strong, nimble, and the global gold standard.
To ensure that FDA can continue to lead the world, BIO respectfully offers three overarching strategies. We must pursue reforms that make clinical development more efficient, regulatory review more predictable, and stakeholder engagement more effective and transparent.
1. Reduce the Time, Cost and Complexity of Early Drug Development
Processes for opening clinical sites and preparing IND submissions are costly, duplicative, and inconsistent. Standardizing expectations and applying risk-based flexibility will lower barriers in the US without compromising patient safety. BIO recommends the following:
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6 Citeline, Pharmaprojects, accessed July 2025. https://www.citeline.com/en/products-services/clinical/pharmaprojects
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* Reduce administrative burdens in clinical trials (e.g. uniform contracts, streamline Form 1572 and standardize informed consent) to accelerate opening clinical sites;
* Explore expansion of single Institutional Review Boards (sIRBs) policies within FDA and across HHS and leverage new technologies for centralizing document collection and coordination;
* Outline expectations and support collaborative efforts to reduce animal testing with the goal of further enabling New Approach Methods (NAMs);
* Clarify toxicology data requirements minimally necessary to initiate clinical testing and expand the use of risk-based approaches that can be scaled based on modality, mechanism of action and clinical risk profile;
* Further Quality Risk Management (QRM) in manufacturing to accelerate the start of INDs and ultimately product approval; and
* Ensure rapid/frequent communications with sponsors throughout drug development but especially during the pre-IND and early IND period.
2. Strengthen FDA's Regulatory Review: Predictability and Efficiency
Predictability and early communication are essential to innovation. By improving first-cycle success rates, advancing modern trial methodologies, and reducing inspectional bottlenecks, the FDA can help maintain the United States' status as the preferred market for global clinical development.
In Fiscal Year 2024, FDA met its overall review time goals -- "the trains ran on time" -- but only 56% of standard and 77% of priority applications were approved in the first cycle, down significantly from recent highs of 67% and 92%, respectively. Moreover, the Agency is meeting only 23 of 32 procedural and processing goals related to meeting management and timely communications per FDA FY 2024 PDUFA Performance Report.
To strengthen FDA's global leadership, BIO recommends the following:
* Improving first-cycle review performance through consistent application of the PDUFA "Enhanced Review Program."
* Streamlining inspections by expanding Remote Interactive Evaluations and leveraging Drug Master Files and mutual reliance on trusted foreign regulators.
* Advancing innovative trial designs (Complex Innovative Designs, Real-World Evidence, Model-Informed Drug Development) and integrating successful pilot programs into routine practice.
* Accelerating biomarker qualification and closing the translational gap through clear evidentiary standards and adequate resourcing.
* Expanding the Platform Technology Designation (PTD) to facilitate review of well-characterized technologies across multiple products.
* Applying expedited development tools and flexible frameworks for chronic diseases, where innovation has lagged despite enormous public health burden.
* Supporting efforts to fulfill PDUFA meeting management goals and continue to evolve meeting best practices. Explore the potential for existing meeting types to be used more effectively to resolve urgent drug development questions.
3. Support New Models for External Engagement and Transparency to Accelerate Innovation
Innovation moves quickly, and no single entity -- not even the FDA -- can maintain expertise across every emerging field. Sustained engagement with the broader ecosystem will help the Agency keep pace with scientific advances and apply policy consistently.
The US biotechnology ecosystem depends not only on the FDA but also on the patients it serves, the medical community that deploys the products it regulates, and the companies that develop and manufacture them. In order to maintain pace with innovation, the entire ecosystem must be further leveraged. BIO recommends the following:
* Further FDA's ability to augment its expertise on emerging science and innovation by evolving the use of Advisory Committees to focus on questions of science rather than questions about the regulations, ensuring appropriate training and balanced participation while updating conflict-of-interest rules.
* Establish common platforms for shared learning across the innovation ecosystem to address cross-cutting scientific and regulatory challenges.
* Fill FDA positions focused on consistently advancing the FDA vision for regulatory science and ensuring consistent implementation across review divisions.
Strengthening America's Biotech Future: Growing U.S. Manufacturing Capacity to Support Industry, Especially Small to Midsize Biotechs BIO is dedicated to supporting growth of the biotech manufacturing ecosystem in the United States. As outlined in the introduction, the journey from discovery to FDA approval is long and costly--typically spanning 10 to 15 years and requiring nearly $1 billion in investment. Out of every 10,000 compounds that enter the discovery phase, only one will make it through to approval, highlighting the immense scientific and financial hurdles involved. To navigate this demanding landscape, biotech companies increasingly rely on contract manufacturers. These strategic partners provide the physical infrastructure, expertise, and regulatory know-how needed to develop and manufacture complex therapies. Contract manufacturers support every stage of product lifecycle--from early research and clinical trials to commercial-scale production--allowing biotech firms to focus on innovation without having to build costly facilities or hire specialized staff. Their role is especially critical for small to mid-size companies that lack the resources to build and manage in-house manufacturing capabilities.
American biotechnology companies of all sizes want to take part in the Trump Administration's drive to bring research, development, and manufacturing back to America. Since January 2025, close to half a trillion dollars has been committed to U.S. manufacturing from the biotech industry--driven mainly by larger, multi-national companies. But for smaller biotechnology companies to also take part, there must be sufficient contract manufacturing capacity within the United States. As service providers, contract manufacturers are not well positioned to quickly scale up without support. Infrastructure and supply chain investment, financial incentives, and workforce development programs are critical areas where government can assist. Success means American biotechnology companies choosing American-based contract manufacturers for developing new products and shifting existing product manufacturing back onshore.
Supporting contract manufacturers for biotechnology products is not just a strategic choice--it's a national imperative. A strong contract manufacturing ecosystem directly correlates to a strong biotechnology ecosystem--creating high-quality American jobs, driving exports that fuel economic growth, and securing our health supply chains to ensure that Americans have access to critical medicines when they need them.
Targeted incentives -- tax, capital, and IP benefits -- will help small and mid-sized firms, and their contract manufacturers, build the infrastructure needed to bring production back to the U.S. BIO respectfully offers the following recommendations for supporting a robust U.S. contract manufacturing ecosystem, thereby strengthening and reinforcing US leadership in biotech innovation.
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Contract manufacturing facilities
* Incentivize servicing low-volume contracts (e.g., preferential tax rates, depreciation benefits, etc.).
* Lower barriers to capital-intensive investments with incentives for facility and equipment buildouts.
* Leverage government guarantees by expanding grant and credit tool programs for biotech manufacturing projects.
* Reward technology adoption and innovation with incentives for advanced systems and pilot-scale facilities.
* Encourage integrated end-to-end facilities through grants and tax benefits.
Biotechnology companies using contract services
* Incentivize transferring technology to the United States.
Equipment and critical raw materials suppliers
* Ensure availability of biotech equipment and critical raw materials by funding and incentivizing domestic production.
* Prioritize long-lead biotech equipment through a national list and incentives for domestic sourcing.
The combined ecosystem
* Encourage regional biotech clusters by incentivizing shared infrastructure, workforce development, and expertise.
* Facilitate access to land and utilities through grants and infrastructure support in development zones.
* Address utilities and logistics barriers by improving infrastructure essential to biotech manufacturing operations.
* Streamline environmental reviews to accelerate biotech facility construction while upholding safety standards.
Workforce development
* Establish standardized biomanufacturing education through national frameworks, degrees, and cGMP-aligned programs.
* Fund biomanufacturing workforce development through grants, apprenticeships, and institutional training support.
* Expand cross-training by funding accelerated programs to upskill science professionals in biomanufacturing.
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Federal oversight and coordination
* Establish federal oversight and coordination mechanisms to unify biomanufacturing efforts across HHS, Commerce, and other agencies.
Strengthening America's Biotech Future: Spur Innovation and Address Unmet Needs for the Most Vulnerable Through Congressional Action Rare disease drug development faces many barriers. Just 5% of the 10,000 known rare diseases have an approved treatment on the market. The Rare Pediatric Disease Priority Review Voucher (RPD PRV) program was created by Congress in 2012 to spur treatments that offer hope to children with few or no treatment options and to provide uniquely American incentives for biotech investment. The RPD PRV serves as a powerful incentive to stimulate the development of therapies for diseases that are not economically viable to pursue - and does so at no direct cost to taxpayers. To date, 53 PRVs have been awarded across 39 rare pediatric diseases. Prior to the creation of the RPD PRV, only 3 of those 39 diseases had any FDA approved treatment.
74% of qualifying drugs who were awarded a RPD PRV are first in disease, indicating that trailblazing innovation is underway and has already improved treatment options for children.
Administered by the FDA, the program has been reauthorized every four years (in 2016 and 2020). Despite bipartisan backing, the program's authorization lapsed in December 2024, halting a vital incentive for drug developers who have historically relied on it to advance novel treatments for rare pediatric diseases. Holding or selling a RPD PRV can be transformative for small and mid-size biotechs, attracting investment or providing critical capital to fund additional research and development. At the same time, the program helps expedite broader patient access to urgently needed treatments. BIO recommends:
* Congress urgently reauthorize the PRV to provide the most vulnerable patients the treatment and hope they so desperately need as well as protect and advance American biotech innovation.
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Conclusion
The United States has led the world in biotechnology for decades -- not by chance, but by design. A science-driven, well-resourced, and globally respected biotechnology ecosystem is essential to not only provide Americans health and hope but also to provide national security. FDA is central to our success; we must ensure that the FDA is equipped -- in authority, staffing, and resources -- to fulfill its dual mission effectively. By modernizing its processes, strengthening collaboration, and embracing its role as both gatekeeper and catalyst, the FDA can continue to ensure that patients benefit from the full promise of American innovation.
Congress must also do its part and act now to spur innovation and address unmet needs for the most vulnerable by reauthorizing the Rare Pediatric Priority Review Voucher (PRV). Finally, as the industry invests in domestic manufacturing, policymakers must consider the full biomanufacturing ecosystem. Targeted incentives -- tax, capital, and IP benefits -- will help small and mid-sized firms, and their contract manufacturers, build the infrastructure needed to bring production back to the U.S.
BIO and our member companies stand ready to partner with Congress, FDA, and all stakeholders to advance these goals.
Thank you for your leadership and commitment to this critical mission. I look forward to your questions.
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Original text here: https://www.help.senate.gov/imo/media/doc/77287bdb-084f-c84c-7a93-3624e7471c2a/Crowley%20Testimony.pdf
Alzheimer's Association Volunteer Montealegre Testifies Before Senate Special Committee on Aging
WASHINGTON, Nov. 14 -- The Senate Special Committee on Aging released the following written testimony by Erick Montealegre, a family caregiver and a volunteer with the Alzheimer's Association, from a Nov. 11, 2025, hearing entitled "Renewing Our Commitment: How the Older Americans Act Uplifts Families Living With Aging-Related Diseases":* * *
Chairman Scott, Ranking Member Gillibrand, and members of the Committee - thank you for the opportunity to testify today.
My name is Erick Montealegre, and I live in Broward County, Florida. I'm a family caregiver, a volunteer with the Alzheimer's Association, ... Show Full Article WASHINGTON, Nov. 14 -- The Senate Special Committee on Aging released the following written testimony by Erick Montealegre, a family caregiver and a volunteer with the Alzheimer's Association, from a Nov. 11, 2025, hearing entitled "Renewing Our Commitment: How the Older Americans Act Uplifts Families Living With Aging-Related Diseases": * * * Chairman Scott, Ranking Member Gillibrand, and members of the Committee - thank you for the opportunity to testify today. My name is Erick Montealegre, and I live in Broward County, Florida. I'm a family caregiver, a volunteer with the Alzheimer's Association,and a small business owner in the senior care field. I've only been in this field for a short time - about a year and a half - but every day reminds me just how vital programs supporting older adults are, not just for families like mine in Florida, but for the nearly 12 million family caregivers nationwide who are caring for someone living with Alzheimer's.
Today, I speak to you first and foremost as a son - one of four adult children doing our best to care for our father, Alberto, who is living with stage 3 mild cognitive impairment. I am proud to have him here with me today. As November is National Family Caregivers Month, it makes today's hearing especially meaningful.
Dad was diagnosed with mild cognitive impairment five years ago, after we first began noticing changes in 2019. Initially, he lived on his own, proud of his independence. But over time, it became clear he needed more support and moved in with my sister. We soon found ourselves learning, often by trial and error, how to balance his independence with safety - and how to find resources that would help him stay connected to his family and his community.
Caregiving, as many of us here know, is emotionally taxing, physically demanding, financially challenging and a full-time responsibility. With the help of our local Area Agency on Aging, we accessed services under the Older Americans Act, which have made a world of difference to his quality of life. At first, Dad received home-delivered meals, which ensured he had healthy food and provided the reassurance of a daily check-in. He then began attending a local adult day center, which has become the heart of his day-to-day life - and, in many ways, the heart of my story. Dad now participates in many activities that keep him engaged and happy, like piano and art. He is able to exercise regularly and safely at the gym they have on-site. He also gets to play chess daily, which is something he has enjoyed throughout his life and allows him to remain socially and mentally engaged. He's 84 years old and, since attending the center, he has taken up dancing - which has been a surprise to all of us. It's encouraging to see him enjoying something new at this stage of life and it gives us hope in his ability to hold back the progression of the disease.
The center provides much more than just recreation. It gives him cognitive stimulation, physical activity, social connection, and dignity. And for my siblings and me, it gives us respite and peace of mind. Knowing he's in a safe, engaging environment allows us to focus on our own families and careers without constant worry. I truly believe that the structure, consistency, and connection that the center provides are key reasons why my father is still doing as well as he is today. It has allowed me to step back from being a "care manager" and freed me to spend time with him as his son.
Dad immigrated to the United States from Colombia back in the 1970s. Over the course of his disease, he's lost some of his English and now speaks primarily Spanish. This can make it difficult for us to communicate with him on complicated topics, such as retirement benefits and planning. The center employs bilingual staff who can speak with him in his native language, helping him and us understand complicated issues around decisions that need to be made. It's hard to overstate what a relief it is to have caregivers who truly understand him and speak his language. They can pick up on nuances in his speech that even I sometimes miss.
Hispanics are one and a half times more likely to develop Alzheimer's disease, making it all the more important to prioritize high-quality, culturally and linguistically appropriate programs. Programs funded through the Older Americans Act are doing exactly that - meeting people where they are and honoring their story. In my culture, caring for our elders is part of who we are, and I hope my children see that example and carry it forward.
Reauthorizing and strengthening the Older Americans Act is an investment in families, dignity, and community. Its programs provide families like ours with structure, valuable resources, support, and hope. Hope that my siblings and I can give Dad the best care possible while balancing our own lives. And hope that, as our country ages, no family will have to walk this journey alone.
Thank you again for the opportunity to testify, and I look forward to your questions.
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Original text here: https://www.aging.senate.gov/imo/media/doc/b8954f8f-d547-f226-5dd5-443d49922e54/Testimony_Montealegre%2011.05.25.pdf
Stanford University Professor Testifies Before Senate Health, Education, Labor & Pensions Committee
WASHINGTON, Nov. 14 -- The Senate Health, Education, Labor and Pensions Committee released the following testimony by Josh Makower, a professor of medicine and of bioengineering at the Stanford University, from an Oct. 29, 2025, hearing entitled "The Future of Biotech: Maintaining U.S. Competitiveness and Delivering Lifesaving Cures to Patients":* * *
Thank you Chair Cassidy, Ranking Member Sanders and Members of the Committee for this opportunity to testify. My name is Dr. Josh Makower and for over 36 years, I have passionately devoted my life to developing therapies and technologies to improve ... Show Full Article WASHINGTON, Nov. 14 -- The Senate Health, Education, Labor and Pensions Committee released the following testimony by Josh Makower, a professor of medicine and of bioengineering at the Stanford University, from an Oct. 29, 2025, hearing entitled "The Future of Biotech: Maintaining U.S. Competitiveness and Delivering Lifesaving Cures to Patients": * * * Thank you Chair Cassidy, Ranking Member Sanders and Members of the Committee for this opportunity to testify. My name is Dr. Josh Makower and for over 36 years, I have passionately devoted my life to developing therapies and technologies to improvepatient care. Over this time, I've founded 11 independent medical device companies which collectively have improved the lives of millions and created thousands of jobs here in the United States. It has been the privilege of my career to see the transformative impact that these innovations have had on patients, as well as their loved ones. This impact is what drives my passion to continue working to improve our healthcare innovation ecosystem and why I am so honored to be here today. In addition to being a physician-inventor and entrepreneur, at Stanford University I am a Professor of Medicine and Bioengineering, and the co-founder and Director of the Stanford Mussallem Center for Biodesign. My focus there is to educate the next generation of innovators, so that they can learn to solve critically important clinical needs, innovate solutions and pioneer new therapies which advance patient care, reduce costs, and improve health outcomes. The opinions in my testimony today are my own and do not represent the opinions of any of the organizations I am affiliated with.
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The promise of innovation to impact human health
Biotechnologies and medical technologies alleviate suffering and save lives. Biotechnology innovation has given us CRISPR gene editing, a revolutionary technology that allows scientists to precisely edit genes by "cutting and pasting" DNA into cells. Technologies like these have the potential to cure cancer, repair or replace damaged tissues and organs, treat spinal cord injuries or grow new skin for burn victims. Medical devices also have lifechanging and lifesaving medical impacts on patients. These devices help the deaf to hear for the first time, the paralyzed to learn to walk again, the blind having their vision restored, or the debilitating symptoms of inflammatory diseases like rheumatoid arthritis to be alleviated. The profound and lasting impact these innovations can have on patients and their families is simply astounding.
My message to the Committee today is simple: the potential for healthcare technologies of the future - both biotech and medtech - to cure diseases, improve people's quality of life, and lower healthcare costs has never been more within our reach. The United States can still lead the world in this important field BUT ONLY with the proper policies in place to support and nurture this incredible fragile ecosystem.
A brief summary of my recommendations are:
1. Address challenges with FDA review for cell and gene therapies by strengthening staffing stability, retaining scientific and clinical expertise, and improving transparency, predictability and reasonableness to the review process to eliminate the "first-mover disadvantage."
2. Protect premarket review staff positions at FDA that are funded by user fees so that when there are vacancies, allow for them to be backfilled "one for one," and for all user-fee supported positions, make those positions exempt from cuts.
3. Ensure that CDRH fully leverages Predetermined Change Control Plans (PCCP) that Congress enacted in 2022 by eliminating unnecessary restrictions on the type and number of changes allowed, to ensure faster patient access to medical devices utilizing AI/ML.
4. Encourage CDRH to engage in interactive review with applicants with minor requests without requiring a majority of those interactions to go through the formal pre-submission process.
5. Expand the 3rd Party Review program to allow CDRH staff to focus time and resources on more complex submissions. For submissions reviewed by 3rd parties, codify that FDA's role is primarily administrative and that it is not appropriate for FDA to engage in a re-review of the submission.
6. Increase the utilization of Real World Evidence to reduce the cost, time and complexity of premarket review and accelerate innovation.
7. Support efforts towards Global Regulatory Harmonization to maintain US competitiveness and turn away from policies which are giving China a distinct advantage against the United States.
8. Congress should pass bipartisan legislation that provides four years of transitional coverage for breakthrough medical devices. My research has shown an average delay of 5.7 years AFTER FDA market authorization before adequate reimbursement is established. This "valley of death" harms small innovators, investors and most importantly, Medicare beneficiaries.
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The heath technology innovation ecosystem
We all rely on a predictable, reasonable, transparent and optimized FDA, to maintain the United States' leadership position. Without it, truly, global innovation and our US health technology ecosystem would be at risk. When barriers to innovation are created, investment declines, and this directly leads to American patients being denied timely access to innovative safe and effective new medical products. In such a climate, a generation of innovation and businesses will be lost, along with the jobs they would have created and the lives they would have saved or improved. I know there is broad bipartisan agreement that we must prevent this from happening.
In order to help ensure that the biotechnology and medical technology ecosystems can continue to address the critical needs of patients and providers, I believe there are certain policies and steps that our leaders can take. As a fellow physician, Chair Cassidy, you know better than anyone that science and data should guide us in determining what the problems are, as well as what solutions could be considered. And so, for several times in my career, I worked with my colleagues to do just that - identify what problems are impacting the innovation ecosystem, and share some suggestions on how to overcome them.
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Cell and gene therapies - challenges with FDA review and the "first mover disadvantage"
Cell and gene therapies (CGTs) is a sector of biotechnology that has been transforming patient care, and has so much more potential. Back in 2024, my colleagues at Stanford and I wanted to examine the perspectives of innovators and investors currently navigating the US regulatory pathway for cell and gene therapies to understand what barriers they might be facing as they try to advance these therapies into patient care.
Innovators and investors have indicated that prolonged regulatory timelines are substantially impacting investment and research and development for a range of extremely important disease states. In our study, a majority of biotech innovators indicated the typical time for a new cell or gene therapy to advance through the FDA process is 6 to 10 years./i
When we followed up to ask what were the main factors driving this extended regulatory timeline, 50% of respondents cited issues such as "reviewer or key staff turnover" and "lack of transparency of the approval process." Unfortunately, a majority of investors indicated that these factors will likely decrease their investments in cell or gene therapies in the future. I know my colleagues who are facing this challenge now and they are being forced to lay off scientists and slow progress to allow their ventures to survive. But it's not just jobs in the US that will suffer, of course, it is the patients awaiting access to these therapies. This is somewhat of a common theme that innovators like myself call the first mover "disadvantage" as our own FDA, presented with a new technological paradigm, struggles to determine how to regulate it properly as other competitors from other countries like China gain runway to catch up.
It's somewhat remarkable that the conditions in this space are similar to the challenges we faced for medical device innovation some 15 years ago. This is actually what propelled my engagement in policy and led me to deliver a similar study, then focused on some of the challenges the FDA were presenting to the medtech innovation ecosystem. At the time, CDRH lacked the reasonableness and transparency that is so critical to innovation, and I along with some of my colleagues, examined what this meant for patients in this country./ii
We conducted a survey of over 200 medical technology companies to generate data on their specific experience and found that on average, innovative new medical devices - created by US companies - were available to U.S. citizens two full years later than patients in other countries. In some cases, American patients waited up to six years longer than patients elsewhere for American-made technologies. These factors were hurting patient care and U.S. competitiveness, and as a result of our work and many others, Congress made the necessary investments and reforms to allow the FDA to correct these troubling dynamics through the Food and Drug Innovation and Safety Act. Since that time, the leadership at CDRH has done an amazing job implementing Congress' reforms, and most, if not all, of those particular issues are behind us. The breakthrough devices program, which Congress established under the overwhelmingly bipartisan, 21st Century Cures Law of 2016, provided more timely interactions with senior review teams. In addition, CDRH continues to reiterate that the threshold for authorization is probable benefits outweigh probable risks, NOT probable benefits versus any potential risks. To see this transformation at CDRH has encouraged me to believe that change can happen and that the power of data, even in politics, can change the course of medicine and innovation in favor of patient care.
I believe it is not happenstance that the solutions to both of these challenges are almost identical. The factors that are now driving long regulatory timelines for cell and gene therapies, such as staff turnover, lack of transparency, and regulatory inefficiencies for cell and gene therapies, can be addressed through thoughtful policies and an innovation-oriented, patient-need-centric mindset. For biotechnologies, FDA is currently attempting to address some of these challenges through the START Pilot Program, but we could do much more. In the future, we need to improve pathways for career development within CBER, prioritize and stabilize support for their staff and leadership, and strengthen their expertise in cell and gene therapies to ensure knowledgeable, science-driven and consistent personnel are assigned to NDA review. Collaboration among innovators and regulators once again is crucial to ensuring that life-saving technologies reach patients in a timely manner.
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Staffing stability, organizational alignment and cross-training are key needs across the FDA
This need for staffing stability at the FDA is really something important across the organization and impacts every Center. FDA Centers need to have a stable and experienced staff to reasonably and predictably implement the regulatory pathways with the resources they are provided, including those from user fees paid by manufacturers innovators. The FDA recently shared that there was a loss of 1,093 employees for CDER and 224 for CBER./iii
The data also show that the pace of hiring at both centers has dramatically stalled. CDER hired just 10 new staff in Q3 and Q4, and CBER just five. CDRH has hundreds fewer employees today than they did a year ago, and had budgetary issues that constrained hiring since early 2024. We appreciate the efforts of this Committee with RIFs earlier in the year to help stabilize staffing levels, but with restructuring and other reforms, there remains a number of critical premarket review vacancies. To FDA's credit thus far, the agency continues to meet their user fee goals, but whether this can be sustained is an open question. With the current hiring freeze, and the policy of "four for one" where for every four employees that left, the agency can hire one new employee, these divisions are likely to experience significant rates of attrition if staff retirements and departures aren't backfilled. I believe it is very important that any premarket review staff for biotechnologies and medical technologies that are funded by user fees should be backfilled in order to help ensure a robust and responsive FDA. In addition, I would suggest that policy should be "one for one" where any user fee funded employee that was lost should be replaced, and that moving forward, any user fee funded positions should exempt to cuts from the federal government due to budgetary constraints.
To properly evaluate emerging biotechnologies and medical technologies, the FDA needs experts in data science, bioengineering, clinical medicine and AI to truly leverage technology in the regulatory pathways. This would strengthen internal expertise to help ensure that regulatory decisions are based on the latest science and technology and the greatest efficiency, safety and speed of review can be achieved.
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Focused process reform will make it easier to achieve efficiency targets with fewer staff - PCCP
Leveraging the latest information technology can enable the agency to handle large datasets and complex algorithms, which are increasingly common in next-generation innovations. At the same time, we do not want to abdicate a reviewers' ability to make determinations. CDRH, for example, has successfully handled the growing integration of machine learning for over 30 years, and there are currently over 1,200 AI-enabled medical technologies that are authorized./iv
However, CDRH could take some steps to better leverage existing authorities to regulate AI/ML when it is within or part of a device system. Just to be clear, I am not recommending that FDA regulate AI used to deliver healthcare decisions, but to the situation where AI is used within the scope of a medical device.
Specifically, I believe that FDA's current implementation of the Predetermined Change Control Plan (PCCP) framework for AI-enabled medical devices could be better aligned with statutory authority, Congressional intent, and least burdensome principles. A PCCP is a plan proposed by a medical device manufacturer that outlines specific, planned modifications to a device and details how those changes will be implemented and validated. The main purpose of a PCCP is to allow for certain device updates--particularly to machine learning-enabled devices (AI/ML)--to be made after initial market authorization without requiring a new regulatory submission for each change. Current and draft guidance at FDA impose unnecessary restrictions on both the types and number of changes allowed in a PCCP, which we believe should be broadened. FDA should also update its guidance to allow PCCPs to be established through any appropriate premarket pathway, including Special 510(k)s, in accordance with the statutory language in Section 515C of the FD&C Act.
FDA guidance also currently recommends extensive documentation for all PCCPs, regardless of the risk level of the device or the proposed modifications. For low-risk devices or changes, these requirements can be very excessive and could result in longer review times and unnecessary delays. Consistent with FDA's established risk-based approach to premarket review and its commitment to least burdensome principles, documentation requirements should be proportional to the risk profile of the device and the specific modifications being proposed. Adapting this proposed approach will help ensure that FDA's review resources are appropriately focused based on the unique risks of each device.
The primary intent of Congress in creating the PCCP framework was to reduce, not increase, regulatory burden on manufacturers. FDA should actively share PCCP best practices, insights, and emerging trends with all stakeholders to promote a shared understanding of the PCCP framework and help further reduce regulatory burden. Together, these steps will support transparent, predictable, and efficient PCCP processes for both regulators and innovators.
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Focused process reform will make it easier to achieve efficiency targets with fewer staff - Pre-sub
It is very important that innovators and regulators look for ways to optimize interactions and engagement to prevent any adverse impact on patient care. I would like to briefly note some concerns that innovators are having with what is known as the "pre-submission" - or "presubs" -- program. This program is designed to provide medical technology innovators with the opportunity to engage in discussions with FDA review teams during the product development process. This proactive approach can clarify requirements, anticipate potential issues, and smooth the path towards the goal of premarket authorization. While the program has noble goals, over the years the numbers of "presubs" has increased dramatically, leading to a strain on resources, and defeating the intended goal of the program.
When the program was initially started there were approximately 1,500 pre-subs a year, but that risen to annually over 4,000 pre-subs today./v
I was encouraged to hear CDRH Director Tarver share her recognition over the summer at the MDUFA VI public meeting that the center aims to enhance the efficiency and clarity through a more standardized, tiered approach to pre-submissions. If the answer to a question can be easily delivered, it really should not require a pre-sub to get the answer.
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Focused process reform will make it easier to achieve efficiency targets with fewer staff - Third-party Review Program
Another area where there could be improvements are CDRH's Third-Party Review Program which has been in place for over 25 years and allows manufacturers to voluntarily submit 510(k) premarket notifications for certain eligible medical devices to accredited third-party review organizations. In fact, during President Biden's administration, the FDA was looking at ways to utilize this program more robustly to save time and resources. The goal is to make the review process for lower-to-moderate risk devices more efficient, freeing up FDA resources to focus on higher-risk devices. The third-party organizations perform the primary review using the same criteria as the FDA, and then sends the submission and a recommendation to the FDA for a final decision. In order to truly maximize the benefits of this program, I believe the guidance should make clear that the FDA's review of the 3rd parties' work is primarily administrative and not to engage in a re-review of the submission. I personally experienced a situation with one of my own companies for a relatively low risk device where the 3rd party review was almost completely set aside, causing substantial delays in patient access and draining this small company's limited resources. Again, I think the aligned objective of this program is to make more resources available for the agency to review more complex technologies and leverage 3rd parties for the simpler submissions. Keeping FDA within the guidelines of the intent of this program would benefit all parties involved in this ecosystem, including the agency.
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Focused process reform will make it easier to achieve efficiency targets with fewer staff - Real World Evidence
Another area of opportunity to drive greater efficiency and effectiveness in the premarket review process involves FDA better leveraging real world data. While FDA has increasingly expressed interest in utilizing real world data for the review process, adoption is still slow. With the cost of evidence generation increasing for innovators, FDA, CMS and all stakeholders should be thinking more creatively about how to tap into this critical data source to accelerate patient access and coverage decisions. Such an approach could lower the demands, delays and costs of pre-market review, and allow technologies and clinical insights to evolve more rapidly, allowing innovation in patient care to advance more efficiently.
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FDA doesn't work in a vacuum - International partners and CMS should be key partners
Finally, as international competition is increasing, especially from the EU and China, the FDA should actively participate in efforts that build efficiencies across organizations. This could take two forms: global regulatory harmonization and increased FDA partnership with CMS.
Global regulatory harmonization efforts would ensure that U.S.-approved biotechnologies and medical technologies are globally competitive. Harmonized standards reduce duplication, speed up international market entry, and strengthen the appeal of the U.S. as a base for innovation. Medical device and biotechnology companies are net exporters. The products we create should be available to Americans first, and then commercialized across the globe but we face substantial challenges now in doing so. Today China is truly threatening the US's leadership, but some of our policies have done more to enable China's aggressive advance than deter them.
Turning lastly to CMS, while the medical technology sector has seen many improvements over the past 15 years regarding the FDA, there unfortunately remains substantial inefficiencies at CMS that is unique to this sector. Increasingly, medical technology innovators are confronting a "valley of death" where their technologies have received FDA authorization, but often no CMS or insurance coverage is in place to allow patients to gain access to them. My colleagues and I at the Stanford Biodesign Policy Program studied just how difficult the environment has become. Our research found that Medicare patients often wait many years to get access to novel FDA-authorized technologies. Our group used publicly available data and discovered that only 44% of novel technologies authorized by the FDA between 2016 and 2019 achieved even the most nominal amount of Medicare coverage by the end of 2022, and the median time to achieve this nominal coverage was 5.7 years./vi
This is too long for American seniors to wait, and it is breaking the investment model in this country that has historically led the world in these innovations. Thankfully I believe there remains strong bipartisan support in the Senate and House of Representatives to address this problem and there are proposals now under consideration to establish a new coverage pathway at CMS to accelerate seniors' access to these technologies. While I recognize that CMS is largely not within this Committee's jurisdiction, I did want to highlight this troubling reality. Initial efforts at CDRH to enable FDA staff to support CMS in their coverage determinations have been hopeful, but not effective enough and Congressional support for this could be very effective in making sure this collaboration happens. I do think it is in scope for this Committee to support advancing this inter-agency collaboration, enabling FDA scientists, physicians and engineers to support CMS in their coverage evaluations and provide a resource to the teams there to accelerate and advance these therapies to American seniors.
In closing, I and my fellow innovators remain committed to working closely with you to reach our shared goal of expediting access to safe and effective biotechnologies and medical technologies to patients and providers in a timely manner, and ensuring that the United States remains the global leader in these important fields well into the future.
Thank you once again Chair Cassidy and Ranking Member Sanders for the opportunity to testify today, and I look forward to answering any questions that you and the Committee Members might have.
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Footnotes:
i Cheyenne Ariana Erika Modina, Sandra Waugh Ruggles, and Josh Makower. 2024. Regulatory Pathway for Cell and Gene Therapies in the United States: Perspectives from Innovators and Investors. Health Management, Policy and Innovation (www.HMPI.org). Volume 9, Issue 3.
ii Makower J, Meer A, Denend L (2010) FDA impact on U.S. medical technology innovation: a survey of over 200 medical technology companies. November 2010 [Google Scholar]
iii https://www.fda.gov/industry/fda-user-fee-programs/center-drug-evaluation-and-research-center-biologics-evaluation-and-research-net-hiring-data-fy-2023)
iv https://www.thefdalawblog.com/2025/07/fdas-latest-lists-for-digital-health-technologies/#:~:text=There%20are%201%2C247%20AI%2Denabled,of%20AI%2Denabled%20device%20applications
v https://www.bioworld.com/articles/721807-fdas-mdufa-report-suggests-pre-sub-interactions-increasing
vi Sexton ZA, Perl JR, Saul HR, et al. Time From Authorization by the US Food and Drug Administration to Medicare Coverage for Novel Technologies. JAMA Health Forum. 2023;4(8):e232260. doi:10.1001/jamahealthforum.2023.2260
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Original text here: https://www.help.senate.gov/imo/media/doc/77287bdb-084f-c84c-7a93-3624e7471c2a/Makower%20Testimony.pdf
Senate Special Committee on Aging Chairman Scott Issues Opening Remarks at Hearing on Older Americans Act
WASHINGTON, Nov. 14 -- Sen. Rick Scott, R-Florida, chairman of the Senate Special Committee on Aging, released the following opening remarks from a Nov. 11, 2025, hearing entitled "Renewing Our Commitment: How the Older Americans Act Uplifts Families Living With Aging-Related Diseases":* * *
"The U.S. Senate Special Committee on Aging will now come to order.
Today, we are once again talking about an incredibly important issue that affects millions of American seniors and their families: the reauthorization of the Older Americans Act (OAA) and its impact on seniors with age-related conditions ... Show Full Article WASHINGTON, Nov. 14 -- Sen. Rick Scott, R-Florida, chairman of the Senate Special Committee on Aging, released the following opening remarks from a Nov. 11, 2025, hearing entitled "Renewing Our Commitment: How the Older Americans Act Uplifts Families Living With Aging-Related Diseases": * * * "The U.S. Senate Special Committee on Aging will now come to order. Today, we are once again talking about an incredibly important issue that affects millions of American seniors and their families: the reauthorization of the Older Americans Act (OAA) and its impact on seniors with age-related conditionslike Alzheimer's and Parkinson's.
The OAA is one of the most quietly impactful laws this country has ever passed.
It's the reason a senior in Naples gets a warm, home-delivered meal through Meals on Wheels.
It's the reason a daughter in Pennsylvania can take a few hours of respite after spending the night caring for her father with Alzheimer's.
It's the reason a man in West Virginia with Parkinson's can still get to his physical therapy appointment using transportation services.
And it's the reason senior centers across the country, including New York, can help coordinate all of these things to support older Americans and their families.
These are just a few examples of the faces of this law. When we talk about reauthorization, we are talking about protecting the people who raised us, served our country, built our communities, and now simply need a bit of our support.
Across the United States, more than 7 million older Americans are living with Alzheimer's, including more than 580,000 in my home state of Florida. Alzheimer's steals memories and independence, often turning spouses and children into full-time caregivers overnight.
Nearly one million Americans live with Parkinson's disease, which slowly robs people of movement, balance, and speech but not of their determination or dignity. Each year, about 90,000 new cases are diagnosed, and behind each one is a family learning to adjust, adapt, and persevere.
Behind each of these numbers is a caregiver--a husband, a wife, a son, or a daughter--providing care around the clock.
More than 11 million Americans provide unpaid care for people living with Alzheimer's or another dementia. Together, they give 19.2 billion hours of informal assistance valued at $413 billion and that doesn't even include caregivers for Parkinson's, ALS, or other chronic diseases of aging.
These are people holding down jobs, raising children, and still finding time to feed, bathe, and comfort a loved one who depends on them. They do it out of love, and they deserve our support.
That is why the Older Americans Act is so vital. It works because it's not a big government approach. It's directing resources to local communities. It's neighbors helping neighbors.
In Florida, I have seen the impact firsthand through our Area Agencies on Aging, our senior centers, and the volunteers who deliver meals, install ramps, and check in on seniors who live alone.
For families living with Alzheimer's, Parkinson's, and other age-related diseases, these programs are not luxuries - they're lifelines. They mean a hot meal, a safe home, a few hours of rest for a caregiver, or a ride that keeps someone connected to their community.
When we talk about reauthorizing the Older Americans Act, we are not just debating policy. We are renewing our commitment to America's seniors.
A commitment that in the United States, we will stand by our parents and grandparents as they age and that when disease or disability strikes, families will not have to face it alone.
Every service made possible by this law represents compassion made real.
That is what government should do: empower communities to care for one another and let them direct resources to meet their local needs because they understand their communities far better than anyone in Washington, D.C. does.
I have said it before, and I will say it again. Our seniors have spent their lives building and serving this country, and this bill is one way we ensure they continue to be supported, respected, and valued.
I am proud to be leading the reauthorization of the Older Americans Act this year with Ranking Member Gillibrand, HELP Committee Chairman Cassidy, and Ranking Member Sanders.
I urge all of my colleagues to support this important legislation so we can continue to honor, protect, and care for America's seniors and the families who stand beside them each and every day."
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Original text here: https://www.aging.senate.gov/imo/media/doc/b8954f8f-d547-f226-5dd5-443d49922e54/Opening%20Statement_Scott%2011.05.25.pdf
Patient Advocate Testifies Before Senate Special Committee on Aging
WASHINGTON, Nov. 14 -- The Senate Special Committee on Aging released the following testimony by patient advocate Stephen Sappington from a Nov. 11, 2025, hearing entitled "Renewing Our Commitment: How the Older Americans Act Uplifts Families Living With Aging-Related Diseases":* * *
Hello Chairman Scott, Ranking Member Gillibrand, and members of the Committee. My name is Steve Sappington. I'm 73 years old, married to my wife Dee for 51 years, and I was diagnosed with Parkinson's disease in 2015. We have five sons and nine grandchildren who keep us busy and motivated.
For about three years ... Show Full Article WASHINGTON, Nov. 14 -- The Senate Special Committee on Aging released the following testimony by patient advocate Stephen Sappington from a Nov. 11, 2025, hearing entitled "Renewing Our Commitment: How the Older Americans Act Uplifts Families Living With Aging-Related Diseases": * * * Hello Chairman Scott, Ranking Member Gillibrand, and members of the Committee. My name is Steve Sappington. I'm 73 years old, married to my wife Dee for 51 years, and I was diagnosed with Parkinson's disease in 2015. We have five sons and nine grandchildren who keep us busy and motivated. For about three yearsbefore my diagnosis, Dee and I noticed strange changes in my health. I was taking tiny steps instead of my usual long strides. My once-clear handwriting became illegible. We went to Longwood Gardens and I suddenly couldn't smell the thousands of blooming flowers. My hands began to shake, and my balance started to deteriorate. We had no idea what Parkinson's disease was. Dee urged me to see our family doctor, who referred me to a neurologist. When I was diagnosed, I was upset -- and frankly, in denial.
A friend of Dee's who also had Parkinson's kept telling me about a local boxing program called Rock Steady Boxing. She said it was life-changing. I wanted nothing to do with it. Why would I want to go to a boxing class? I was angry and ignoring the obvious. But eventually, I gave in and went to observe a class, finding it interesting and fun. Everyone there had Parkinson's, each at different stages, and the exercises were designed specifically to combat symptoms of the disease. Everyone was friendly and welcoming. I started going to the free, hour-long classes four to six times a week. The results came slowly but surely: better balance, improved strength, and a huge boost in mood. I went religiously for 18 months. Then I learned the funding for the classes was in jeopardy.
After talking with the gym owner and certified trainers, I realized I couldn't let the classes stop. More than 200 older adults with Parkinson's were benefiting from these free classes. I decided to start a nonprofit in late 2017 to raise money to keep them going. In April 2018, I helped create Rally Against Parkinson's (RAP) to keep the classes going. Getting it started took a lot of work. We were a group of unpaid volunteers -- all seniors, most living with Parkinson's -- who had no experience running fundraisers. We learned on the job because we knew what these classes meant to us.
We applied for a Community Grant-in-Aid through the Community Outreach Office. We were denied the first year, but the next year we received half of what we requested -- about $10,000. The full cost to run the program was more than $30,000 a year, so we organized several fundraisers annually to make up the difference. RAP has always been a no-cost program, using 100 percent of every dollar raised to pay for the classes.
When COVID hit and gyms closed, we didn't stop. We quickly adapted by holding socially distanced classes in the gym's parking lot and launching Zoom sessions for those who couldn't or preferred not to leave home. As the program grew, we expanded to our local YMCA and secured a county grant to purchase equipment. Today, our program includes four in-person classes each week, two livestream classes added during the pandemic, and two additional sessions hosted at the YMCA.
At 71, I decided it was time to step back and was fortunate to find another volunteer -- a young 65-year-old -- to take over as president. My neurologist calls me "a miracle." He says it's rare to see someone with Parkinson's remain at the same medication level for eight years. I credit that to consistent exercise and the community built through programs like RAP.
Programs like ours are possible because of the foundation created by the Older Americans Act (OAA). Local OAA-funded services, including transportation, congregate and home-delivered meals, caregiver support, adult day services, and other supportive programs, make it possible for older adults like me to stay active and connected.
These services work together:
* Transportation helps participants get to classes and support groups.
* Nutrition programs provide meals that support health and energy.
* Caregiver support allows family members to continue their vital role.
* Title III supportive services give local agencies the flexibility to meet community needs.
Without this infrastructure, many older adults wouldn't be able to participate in programs that improve their health and well-being.
Despite progress, several challenges remain. Many older adults are unaware of available services, underscoring the need for culturally competent outreach - particularly to low-income, rural, and minority communities. Even when programs are accessible, transportation barriers often prevent participation; funding through the OAA helps address these gaps. Additionally, sustaining free or low-cost programs is difficult due to limited unrestricted funding. These initiatives rely heavily on consistent public investment and strong local partnerships to remain viable.
To ensure that older adults with Parkinson's and other age-related diseases can thrive, I respectfully recommend that Congress:
1. Reauthorize the Older Americans Act this year and maintain or increase funding for:
* Title III nutrition programs
* Title III B supportive services (including transportation and in-home supports) Caregiver support programs
2. Provide dedicated outreach and capacity-building funding so local agencies can reach underserved seniors, including those in rural and minority communities.
3. Support flexibility for virtual and hybrid programming, such as livestreamed exercise classes, so homebound seniors can stay active and connected.
4. Sustain funding for transportation and meal programs, which are foundational to participation in community exercise and wellness programs.
As a patient advocate, I'm encouraged by Congress's bipartisan passage of the National Plan to End Parkinson's Act, now being implemented by the federal government. This law creates the first-ever whole-of-government strategy to prevent, diagnose, treat, and ultimately cure Parkinson's disease. It also establishes a federal advisory council to coordinate research and services across agencies and address the needs of caregivers and families.
From my perspective, this effort complements the Older Americans Act. The OAA ensures that people like me can live well today, while the National Plan builds the roadmap for tomorrow. Together, they represent hope: hope for better quality of life now, and hope for a future without Parkinson's disease.
We don't yet have a cure for Parkinson's and we need strong federal investment in research to get there. While researchers work every day toward that goal, I'm proud to do my part through studies like the Parkinson's Progression Markers Initiative (PPMI) to help advance our understanding of Parkinson's Disease. Programs funded and authorized under the Older Americans Act keep people like me moving, connected, and cared for. They make the difference between being isolated at home and living a full life with community, purpose, and dignity.
Thank you for considering these requests. I welcome follow-up questions and will gladly help the Committee understand how OAA services directly improve outcomes for people living with Parkinson's and their caregivers.
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Original text here: https://www.aging.senate.gov/imo/media/doc/b8954f8f-d547-f226-5dd5-443d49922e54/Testimony_Sappington%2011.05.25.pdf
Ohio District 5 Area Agency on Aging CEO Patton Testifies Before Senate Special Committee on Aging
WASHINGTON, Nov. 14 -- The Senate Special Committee on Aging released the following written testimony by Duana Patton, CEO of Ohio District 5 Area Agency on Aging Inc., from a Nov. 11, 2025, hearing entitled "Renewing Our Commitment: How the Older Americans Act Uplifts Families Living With Aging-Related Diseases":* * *
Chairman Scott, Ranking Member Gillibrand and members of the Committee, thank you for the opportunity to speak before you today. My name is Duana Patton, and I am honored to serve as the Chief Executive Officer of the Ohio District 5 Area Agency on Aging, Inc., where I have worked ... Show Full Article WASHINGTON, Nov. 14 -- The Senate Special Committee on Aging released the following written testimony by Duana Patton, CEO of Ohio District 5 Area Agency on Aging Inc., from a Nov. 11, 2025, hearing entitled "Renewing Our Commitment: How the Older Americans Act Uplifts Families Living With Aging-Related Diseases": * * * Chairman Scott, Ranking Member Gillibrand and members of the Committee, thank you for the opportunity to speak before you today. My name is Duana Patton, and I am honored to serve as the Chief Executive Officer of the Ohio District 5 Area Agency on Aging, Inc., where I have workedfor nearly 31 years. Our Agency, located in Ontario, Richland County, Ohio, is one of 613 Area Agencies on Aging (AAAs) across the nation that helps older adults remain independent and supported in their communities. I am also the current Board President of USAging, the national association of AAAs. On behalf of these agencies--and the millions of older adults and family caregivers we serve--I want to express my gratitude for your continued commitment to meeting the needs of individuals, families, and caregivers through the Older Americans Act (OAA). As the older adult population in the United States continues to rise rapidly, AAAs have seen increased demand for OAA programs and services across the country. In 2022, older adults numbered 57.8 million, representing 17.3 percent of the population and the number of older adults has increased by 34 percent since 2012 compared to an increase of 2 percent in the population under age 65. The older adult population is expected to continue to grow significantly in the future and is projected to reach 88.8 million in 2060./i
Strengthening the OAA, which is administered by the Administration for Community Living (ACL), over the next decade will be critical as it is the cornerstone of the nation's non-Medicaid home and community-based services (HCBS) system serving nearly 11 million older Americans per year across the country. The Aging Network carries out these services and includes State Units on Aging (SUAs), AAAs, Title VI Native American Aging Programs (Title VI programs) and tens of thousands of local service providers.
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Older Americans Act Overview and Background on Area Agencies on Aging
Signed into law in 1965, the OAA has connected older adults and their caregivers to services that help older adults age with health, dignity and independence in their homes and communities--where they want to be. The OAA enables the local delivery of home and community-based services, which are almost always less expensive than institutional care provided in nursing homes or assisted living facilities. The longer older adults can successfully age at home, the better it is financially for families and the federal government. OAA programs and services also support healthy aging and address upstream drivers of health./ii
AAAs were formally established in the 1973 OAA as the "on-the-ground" organizations charged with helping vulnerable older adults live with independence and dignity in their homes and communities. For 50 years, AAAs have served as the local leaders on aging and the OAA was intentionally designed to give AAAs the flexibility to ensure that the local needs and preferences of older adults are considered and reflected in the design and implementation of local service delivery systems./iii
Across the country, AAAs play a vital role in supporting both individuals living with aging-related diseases and their caregivers, thanks to the foundation provided by the OAA. As an AAA, our mission is to plan, fund and deliver a broad range of programs and services rooted in the demonstrated needs of the communities we serve. We are often the "front door" to aging services, receiving referrals from individuals, caregivers, physicians and community partners--often at a time when a person is facing a new or increasing risk related to aging. Once AAAs receive input from consumers, service providers and other stakeholders, we develop Area Plans, which outline local needs and propose recommendations for programs and services for older adults and caregivers. Through comprehensive assessments, we determine what supports and interventions will best promote their health, safety and independence. When an individual comes to the AAA, they are not coming for health care, they are coming to seek support in navigating challenges and risks associated with their health condition.
AAAs are social care experts and we know that social needs often drive health outcomes. The core services we provide include nutrition, supportive services, caregiver support, health and wellness and elder rights. Our person-centered approach and assessment expertise recognizes the health of the person and focuses on interventions that will foster better outcomes. A good example is that of Ms. Gray. Ms. Gray was referred to our AAA following a hospital stay for a chronic health condition. She was not complying with her medication regimen and had poor eating habits. By providing two hours a week of personal care in her home as well as home-delivered meals, Ms. Gray has improved health, both physically and mentally, and has not been admitted to the hospital since receiving these services. This is the powerful impact of the OAA.
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Key OAA Programs Supporting Older Adults with Aging-Related Diseases
OAA Title III B Supportive Services
OAA Title III B Supportive Services is the bedrock of the Act and provides states and local agencies with flexible funding to provide a wide range of supportive services to older Americans like Ms. Mary. These services include in-home services for frail older adults, senior transportation programs, Information and Referral/Assistance Services (e.g., hotlines to help people find local services, resources), case management, home modification and repair, chore services, legal services, social engagement activities, emergency/disaster response efforts and other person-centered approaches to helping older adults age well at home. Services provided through Title III B are a lifeline for older adults and are heavily based on assessed local needs and the desires of older adults in that community./iv
These services are especially critical for older adults with aging-related diseases such as Alzheimer's and Parkinson's disease. As their diseases progress and their needs change, the AAA can adjust the type or intensity of services provided to meet the client where they are.
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OAA Title III C Nutrition Services Program
To meet the nutrition needs of older adults, all AAAs provide nutrition services through the OAA Title III C Nutrition Services Program. OAA Title III C is the largest program in the United States that provides nutrition services to older adults in need and provides older adults with opportunities for optimal health and well-being, reduced food insecurity and chances for social interaction with peers. AAAs, working with contracted community-based partners, provide both congregate and home-delivered meals to older adults in their service areas. Congregate meals sites can include senior/community centers, senior cafes, schools, churches, farmers markets and other places where older adults gather. Home-delivered meals are available to older adults who are homebound or otherwise have difficulty getting to congregate sites. The OAA also allows AAAs to provide nutrition education, risk screening and counseling to older adults. Like under Title III B, AAAs have some flexibility under Title III C and can adjust services as a client's needs change. For example, an older adult newly living with Parkinson's or dementia may at first benefit from attending a congregate meal program in their community. However, should their disease progress, and they experience increased difficulty leaving their home, the AAA may offer transportation to the congregate site or, if needed, switch to providing home-delivered meals.
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OAA Title III D Evidence-Based Health Promotion and Disease Prevention Programs
In addition to nutritional needs, the OAA also supports healthy aging for older adults through Title III D Evidence-Based Health Promotion and Disease Prevention. OAA Title III D was established in 1987 to provide formula grants to State Units on Aging to support healthy lifestyles and behaviors among adults age 60 and older with priority given to those in greatest economic need and living in medically underserved areas of the state./v
Decades later, Congress required the programs to be evidence-based. Of the formally recognized by ACL evidence-based programs, AAAs are most likely to deliver the following: A Matter of Balance, Chronic Disease Self-Management Program, Diabetes Self-Management Program, Tai Chi for Arthritis and Powerful Tools for Caregivers. The impact of the OAA--and the Aging Network that brings it to life--is deeply personal and person-centered. For example, one older gentleman in our region who was living with Parkinson's disease enrolled in a Title III D falls prevention class at the recommendation of his physician after experiencing a fall. The program provided him with exercises and education to reduce his fall risk, improving both his confidence and his quality of life.
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OAA Title III E National Family Caregiver Support Program
Lastly, the OAA provides critical support to the family caregivers of older adults living with aging-related diseases through the Title III E National Family Caregiver Support Program (NFCSP). The NFCSP funds local AAAs to assist older caregivers and family members caring for older loved ones by offering a range of in-demand supports to family caregivers in every community. An estimated 63 million Americans provide care for an older adult, or someone living with illness or disability, nearly a 50 percent increase since 2015. Nearly half of care recipients are age 75 or older and face multiple chronic health conditions with the most common primary conditions including age-related decline, Alzheimer's or other dementias, mobility limitations, cancer and postsurgical recovery./vi
Family caregivers provide a wide range of services, such as transportation, food preparation, housekeeping and personal care, enabling care recipients to live at home or in the setting of their choice with dignity and independence. OAA Title III E services include respite care; individual counseling and support groups; caregiver education classes/training; and emergency assistance. AAAs also play a crucial role in information and referral and caregiver navigation, ensuring families are connected with local providers who can help them create a caregiving plan, address specific challenges and ensure they receive the right services at the right time.
Caregivers supporting older adults are not only family members but can also be paid professional caregivers. However, the nation is experiencing grave direct care workforce shortages which have contributed to greater strain on already stressed family caregivers and puts the health and safety of millions of older adults without other caregivers at risk. The direct care workforce includes professionals such as personal care attendants, home health aides, residential workers and more. The United States does not currently have the caregiving workforce it needs to support the rising number of older adults who need personal, in-home care or institutional support. The pay is low (median earnings of $23,688 annually) and the work is physically and mentally demanding with very limited opportunities for career advancement.vi While not directly supported by OAA Title III E, the direct care workforce provides critical support to family caregivers and should not be ignored. Without professional caregivers, older adults have an increased chance of receiving low quality care, which threatens their lives and health.
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OAA Reauthorization
Authorization of the OAA expired last year and since the last reauthorization of the OAA in 2020, AAAs have identified new opportunities to be even more responsive to the evolving needs of older adults. During the pandemic, we were challenged to adapt--and that adaptation sparked innovation. When congregate meal sites had to close, AAAs were permitted to provide "grab-and-go" meals, allowing older adults to maintain access to nutritious food and social connection in a safe way. One participant, a man with diabetes, began using the program because he wanted to avoid grocery stores during the pandemic. He later shared that the meals helped him lose weight and reduce his medications. Today, he continues to attend congregate meal sites and actively manages his condition. To reflect the needs of today's older adults and preserve OAA's inherent flexibility and locally driven structure, it is critical for the OAA to be reauthorized, and I urge Congress to swiftly pass the bipartisan, bicameral reauthorization bill that fell out of last December's final spending package.
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Conclusion
The lessons we learned during the pandemic underscore the importance of allowing AAAs to continue using innovative practices that have proven effective. The timing of this reauthorization is ideal--it gives us the opportunity to strengthen what works, modernize where needed and ensure the Act continues to meet the needs of older adults, caregivers and communities across the nation. Chairman Scott, Ranking Member Gillibrand and members of the committee, thank you for the privilege to share my passion and stories from the field. This day is particularly meaningful; not only because it marks my Mother's 82nd birthday, but also because this opportunity stands as a cornerstone moment in my career dedicated to serving older adults like my Mom.
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Footnotes:
i Administration for Community Living, 2023 Profile of Older Americans (2024)
ii USAging, Older Americans Act: Get the Facts (2025)
iii USAging, Area Agencies on Aging: Local Leaders in Aging Well at Home (2023)
iv USAging, Policy Priorities 2025: Promote the Health, Security and Well-Being of Older Adults (2025)
v Administration for Community Living, Health Promotion (2025)
vi AARP and the National Alliance for Caregiving, Caregiving in the US Research Report (2025)
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Original text here: https://www.aging.senate.gov/imo/media/doc/b8954f8f-d547-f226-5dd5-443d49922e54/Testimony_Patton%2011.05.25.pdf
Harvard Medical School Professor Testifies Before Senate Health, Education, Labor & Pensions Committee
WASHINGTON, Nov. 14 -- The Senate Health, Education, Labor and Pensions Committee released the following testimony by Harvard Medical School Professor Aaron S. Kesselheim from an Oct. 29, 2025, hearing entitled "The Future of Biotech: Maintaining U.S. Competitiveness and Delivering Lifesaving Cures to Patients":* * *
Chairman Cassidy, Ranking Member Sanders, and Members of the Committee:
My name is Aaron Kesselheim. I am an internal medicine physician, lawyer, and a Professor of Medicine at Harvard Medical School, in the Division of Pharmacoepidemiology and Pharmacoeconomics of the Department ... Show Full Article WASHINGTON, Nov. 14 -- The Senate Health, Education, Labor and Pensions Committee released the following testimony by Harvard Medical School Professor Aaron S. Kesselheim from an Oct. 29, 2025, hearing entitled "The Future of Biotech: Maintaining U.S. Competitiveness and Delivering Lifesaving Cures to Patients": * * * Chairman Cassidy, Ranking Member Sanders, and Members of the Committee: My name is Aaron Kesselheim. I am an internal medicine physician, lawyer, and a Professor of Medicine at Harvard Medical School, in the Division of Pharmacoepidemiology and Pharmacoeconomics of the Departmentof Medicine at Brigham and Women's Hospital in Boston, one of the main Harvard teaching hospitals. Within the Division, I lead the Program On Regulation, Therapeutics, And Law (PORTAL), an interdisciplinary research center that studies the intersections between prescription drug affordability and use, laws and regulations related to medications, and the development and cost of drugs. PORTAL is one of the largest non-industry funded research centers in the country that focuses on pharmaceutical use, law, and economics.
In 2020, I was elected to the National Academy of Medicine.
The topic of today's hearing is how Congress can help support the future of biotechnology innovation. One of the primary ways is ensuring that essential biotechnology products are discovered and developed to treat medical conditions, a process that is driven by public research funding in the US through the National Institutes of Health (NIH) and other federal agencies. But in the last nine months, the government has moved to cut NIH funding by 40%.
Another way Congress can support the transformative patient impact of biotechnology innovation is by helping make such innovation available to the patients who need it. This means ensuring that new therapies are sold at reasonable prices, since high costs can limit patient access. The Inflation Reduction Act (IRA) initiated a process of drug price negotiation for Medicare, but further steps should be taken to ensure that negotiation occurs in a timely fashion and that high-expenditure drugs are not exempted. I strongly urge this Committee to incentivize public investment in biotechnology discovery while promoting fair prices.
I. Research Supported by the National Institutes of Health Is a Main Engine of Biotechnology Innovation1
The discovery of new therapeutic interventions typically begins with foundational research, followed by translational studies and proof-of-concept testing in laboratory settings and patients.
Countless reviews and studies show the central role that NIH plays in advancing such therapeutic discovery.2 Much of the NIH's funding focuses on early drug discovery and development stages when private investment is least available due to the high level of risk. These early stages include researching disease mechanisms, identifying modifiable biochemical pathways, isolating druggable targets, and developing systems for in vitro testing of potential drug candidates.3 The NIH's track record in supporting basic and translational research that underlies therapeutic innovation is particularly strong as it relates to biotechnology, the topic of the hearing today.
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1 This testimony derives in part from testimony that I gave to the House of Representatives on April 8, 2025 and on May 10, 2023. See, e.g., Kesselheim AS. National Institutes of Health funding, drug price negotiation, and biosimilars: three factors essential for patients and pharmaceutical innovation. Hearing before the House Subcommittee on Health of the Committee on Ways and Means (Rep. Buchanan, Chairman). 8 April 2025. United States Congressional Record. Available on-line at: https://waysandmeans.house.gov/wpcontent/ uploads/2025/04/Kesselheim-Testimony-1.pdf
2 See, e.g., Stevens AJ, Jensen JJ, Wyller K, Kilgore PC, Chatterjee S, Rohrbaugh ML. The role of public-sector research in the discovery of drugs and vaccines. N Engl J Med. 2011 Feb 10;364(6):535-41; Sampat BN, Lichtenberg FR. What are the respective roles of the public and private sectors in pharmaceutical innovation? Health Aff (Millwood). 2011 Feb;30(2):332-9.
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Over the past decade, biotechnology products supported by NIH--which include biologic drugs, vaccines, and cell and gene therapies--have been growing as a share of new drug approvals and, in some cases, have shifted the paradigm for treating disease.
The NIH's investment in biotechnology products can range from relatively small sums invested at early development stages to far more substantial investment at later stages. For example, my colleagues and I recently completed a study on the cancer drug ibrutinib (Imbruvica), the first-inclass BTK inhibitor, which originated in a small biotech company, Pharmacyclics. In this case, federally-supported researchers discovered the genetic sequence of BTK and were involved with early testing of ibrutinib.4 In part due to public support for early-stage research, ibrutinib cost as little as about $10-12 million to develop through preclinical and Phase I testing, far less than many other pharmaceuticals.5 It was not until ibrutinib's commercial and clinical potential became clear in early-stage trials that its developers invested hundreds of millions in the drug's late-stage trials. On the other end of the financial spectrum, during the COVID-19 pandemic, government funding supported advancements in lipid nanoparticles, mRNA technology, and the SARS-CoV-2 spike protein structure to help understand the virus and provide a guaranteed market for the vaccines, which played a vital role in the rapid development of vaccines that protected millions from COVID-19 complications, with a total investment of at least $31.9 billion.6 In the case of CAR-T treatments that have proven useful in various forms of cancer, substantial public funding helped support their discovery, with large companies entering later in the development process.
The CAR-T treatment brexucabtagene autoleucel (Tecartus) was codeveloped by the National Cancer Institute, Tel Aviv Sourask Medical Center and Cabaret Biotech, the latter being a research spin-off of Israel's Weizmann Institute.7 Even for gene therapies without direct origins in academic research settings like idecabtagene vicleucel (Abecma), the first CAR-T cell therapy for multiple myeloma, the underlying technology directed towards aspects of T cell-based products that target B-cell maturation antigen derived from work done at the NIH.8 For these cellular-based therapies, licensing agreements with private companies allowed for important subsequent development. Key discoveries related to tisagenlecleucel (Kymriah) arose from scientists at the University of Pennsylvania, who entered into licensing agreements with Novartis.9 Public funding made meaningful financial contributions to the development of axicabtagene ciloleucel (Yescarta), for treatment of B-cell lymphoma, through grants provided by NCI to universities and academic medical centers.10 According to our estimates, taxpayers spent over $100 million on early- and late-stage development of axicabtagene ciloleucel, including the refinement of its manufacturing process and early-phase clinical testing.
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3 See, e.g,. Barenie RE, Tessema FA, Avorn J, Kesselheim AS. Public funding for transformative drugs: the case of sofosbuvir. Drug Discovery Today 2021;26(1):273-281 (finding $60.9 million in NIH funding linked to the development of sofosbuvir [Sovaldi] for chronic hepatitis C virus infection, including key work on virus cell culture systems).
4 Bendicksen L, King LP, Scheffer Cliff ER, Kesselheim AS. Discovering a Transformative Cancer Drug: The Case of Ibrutinib. Drug Discovery Today 2025 (in press).
5 Id.
6 Lalani HS, Nagar S, Sarpatwari A, Barenie RE, Avorn J, Rome BN, Kesselheim AS. US Public investment in the development of mRNA COVID-19 vaccines: retrospective cohort study. BMJ 2023;380:e073747.
7 Vokinger KN, Avorn J, Kesselheim AS. Sources of innovation in gene therapies--approaches to achieving affordable prices. New England Journal of Medicine 2023;388(4):292-295
8 Id.
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In addition to cell therapies, all FDA-approved gene therapies can be traced back to academic and research institutions or spin-offs from research efforts at those institutions.11 For example, the the gene therapy voretigene neparvovec (Luxturna) for inherited blindness was developed by researchers at the Children's Hospital of Philadelphia, University of Pennsylvania, Cornell University and University of Florida.12 Spin-offs from these publicly-funded research institutions also played a major role.13 The federal government was a major catalyst for the new sickle cell disease (SCD) gene therapies.14 Viral vector technology used in SCD gene therapy was developed in part at the NIH.15 CRISPR technology, a therapeutic treatment modality for SCD gene therapy, was invented at academic institutions with extensive NIH support.16 Ongoing clinical trials to study the effects of SCD gene therapies additionally received funding from the NIH, with some studies using NIH facilities as trial sites.17
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9 Id.
10 US Senate Health, Education, Labor, and Pensions Committee Majority Staff Report. Public Investment, Private Greed. June 12, 2023.
11 Vokinger KN, Avorn J, Kesselheim AS. Sources of innovation in gene therapies--approaches to achieving affordable prices. New England Journal of Medicine 2023;388(4):292-295
12 Id.
13 Id.
14 Tessema FA, Sarpatwari A, Rand LZ, Kesselheim AS. High-priced sickle cell gene therapies threaten to exacerbate US health disparities and establish new pricing precedents for molecular medicine. Journal of Law, Medicine & Ethics 2022;50(2):380-384
15 Id. National Institutes of Health. NIH researchers create new viral vector for improved gene therapy in sickle cell disease. U.S. Department of Health & Human Services; 2019. Available from: https://www.nih.gov/newsevents/ news-releases/nih-researchers-create-new-viral-vector-improved-gene-therapy-sickle-cell-disease; Uchida N, Hsieh MM, Raines L, Haro-Mora JJ, Demirci S, Bonifacino AC, et al. Development of a forward-oriented therapeutic lentiviral vector for hemoglobin disorders. Nature Communication 2019;10(1):4479.
16 Doudna J, Marson A. Federal funding for basic research led to the gene-editing revolution. Don't cut it. Vox. 2017. Available from: https://www.vox.com/the-big-idea/2017/4/22/15392912/genes-science-march-nih-fundingbasicresearch-doudna; Sherkow JS. CRISPR Patent Landscape: Past, Present, and Future. CRISPR Journal 2018;1:5-9.
17 Bluebird bio. Longterm Follow-up of Subjects with Hemoglobinopathies Treated with Ex Vivo Gene Therapy. Clinicaltrials.gov. U.S. National Library of Medicine; 2020. Available from: https://clinicaltrials.gov/ct2/show/NCT02633943?cond=sickle+cell+gene+therapy&draw=3&rank=9; Bluebird bio. A Study Evaluating the Safety and Efficacy of the LentiGlobin BB305 Drug Product in Severe Sickle Cell Disease. Clinicaltrials.gov. U.S. National Library of Medicine;2020. Available from: https://clinicaltrials.gov/ct2/show/NCT02140554?cond=sickle+cell+gene+therapy&draw=3&rank=10; Thompson AA, Walters MC, Kwiatkowski J, Rasko JEJ, Ribeil J-A, Hongeng S, et al. Gene Therapy in Patients with Transfusion-Dependent B-Thalassemia. New England Journal of Medicine 2018;378(16):1479-1493.
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A few studies have assessed drug development histories and public-sector research in the development of biologics and other biotechnology products. In a study published in JAMA Internal Medicine, we found that about two-fifths (42%) of new biologic drugs approved between 2008 and 2017 had late-stage reliance on public funding or could be traced to companies that were spun off from publicly-supported research.18 Biologics with links to public funding were also more likely to have indicators of therapeutic importance, such as qualifying for expedited regulatory approval. This is consistent with the growing recognition that government, academic, and non-profit funding plays a substantial late-stage role in new drug discovery and development. We also found several examples in which public support was directly used to finance the clinical testing of a drug. Many of these examples were for drugs treating rare diseases or with biosecurity implications (e.g., anthrax antitoxin) for which there may not be financial incentives from the private market.19
Despite this track record, the current Presidential administration has already threatened NIH funding and is poised to do substantially more damage. This year, the administration has targeted universities, blocking funds from scientists and other researchers doing groundbreaking work.20 According to a review by the Brookings Institution, the health budget for 2026 includes only $27.5 billion for NIH, about a 40% from the 2025 appropriation of $48 billion.21 Although the final budget should depend on Congressional action, about one-in-eight drugs approved since 2000 could have been at risk had those cuts been in place at the time given the "extensive connections between medical advances and research that was funded by grants that would have been cut if the NIH budget was sharply reduced."22
The cuts will affect innovation in all fields of medicine, including breast cancer23 and HIV.24 The destruction of funding will lead to losses in opportunities for scientific discovery not only in the short-term, but for generations to come as future scientists are driven out of the US or into other fields entirely.25 There is also no way that private investment can make up for such shortfall. As my colleague Jerry Avorn put it, "The amount available to universities from pharma is smaller; despite the industry claim that it is the wellspring of pharmaceutical innovation, most major companies spend a far smaller share of revenues on innovative research than on promotion and marketing, stock buyback programs, shareholder dividends, and executive compensation."26 NIH support leads to new medical innovation while it also has supported the US economy; according to one advocacy organization, "the $36.94 billion awarded to researchers in the 50 U.S. states and the District of Columbia in FY2024 supported 407,782 jobs and $94.58 billion in new economic activity nationwide -- or $2.56 for every $1 invested."27
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18 Nayak R, Lee CC, Avorn J, Kesselheim AS. Public-sector contributions to novel biologic drugs. JAMA Internal Medicine 2021;181(11):1522-1525.
19 Lupkin S. How Operation Warp Speed's Big Vaccine Contracts Could Stay Secret. National Public Radio. September 29, 2020. Available at: https://www.npr.org/sections/health-shots/2020/09/29/917899357/how-operationwarpspeeds-big-vaccine-contracts-could-stay-secret.
20 Johnson CY, Douglas-Gabriel D, Brasch B. Trump slashed university funding. Here are 6 key drugs that relied on it. Washington Post. Oct 7, 2025.
21 Frank RG. The 2026 Health and Health Care Budget. June 27, 2025. Available at: https://www.brookings.edu/articles/the-2026-health-and-health-care-budget/
22 Azoulay P, Clancy M, Li D, Sampat BN. What if NIH had been 40% smaller? Science. 2025;389(6767):1303-1305.
23 Coffey S. Concerns rise over NIH budget cuts impact on breast cancer research, innovation. Yahoo.com News. October 24, 2025.
24 Ryan B. Republicans seek deep cuts to HIV prevention and treatment funding.. NBC News. March 26, 2025 (one expert projected that one cut to HIV programs "would raise the number of new infections by 12% by 2030.")
25 Witze A. 75% of US scientists who answered Nature poll consider leaving. Nature March 27, 2025, available at: https://www.nature.com/articles/d41586-025-00938-y (poll of over 1600 scientists find that many are looking for work in Europe and Canada).
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The US government has for decades played a fundamental role in the discovery and development of important new drugs and vaccines through the NIH and other sources of public funding. In the face of meaningful budget cuts initiated by the Trump administration and its appointees at the NIH and other agencies, Congress must do whatever it can to re-establish the normal flow of these funds before the US scientific establishment and the prospect of a new generation of innovative treatments is irreparably damaged.
II. Biotechnology Innovation Must Be Available to Patients at Fair Prices
Impactful biotechnology innovation also depends on the therapeutic products being available to patients at fair prices that adequately recognize the private investment in those products.
Congress must ensure that US patients and the health care system do not pay excessive prices for biotechnology products that are out of proportion to the value they offer patients and do not account for the substantial public investment that can accompany these products' development.
In the US, we allow manufacturers to price their products at whatever level they want, which leads biotechnology companies to establish high prices that can limit patient access and strain the budgets of payers, including government insurance programs like Medicare and Medicaid. For example, US health care spending on biologic drug products is rising. In the 5-year period 20192024, in retail settings, spending on biologics rose 80% versus only 14% for small-molecule drugs.28 Medicare Part B spending on biologics more than tripled from 2008 to 2021, with biologics representing 79% of Medicare Part B prescription drug spending in 2021. Cellular and genetic therapies are also priced at exceedingly high levels, sometimes surpassing a million dollars per treatment. For example, at the published price of $2.2 million for an SCD gene therapy, we estimated a 5-year budgetary impact for state Medicaid programs of $837.5 million, with one product alone reaching nearly one-fifth of overall state spending on SCD.29
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26 Avorn J. Corporate support cannot make up for threats to the NIH budget. STAT News First Opinion. Oct 22, 2025. Avialable at: https://www.statnews.com/2025/10/22/nih-budget-cuts-pharmaceutical-industry-research/ ("Greater reliance on corporate largesse can never be a satisfactory alternative to a healthy and adequately budgeted source of peer-reviewed public support.")
27 United for Medical Research. UMR Releases Annual NIH Economic Impact Report: 2025 Update. March 11, 2025. Available at: https://www.unitedformedicalresearch.org/statements/umr-releases-annual-nih-economicimpactreport-2025-update/
28 IQVIA. Biosimilars in the United States 2023-2027. Available from: https://www.iqvia.com/insights/the-iqviainstitute/ reports-and-publications/reports/biosimilars-in-the-united-states-2023-2027.
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The growing challenge of paying for biotechnology products has raised questions about the fair pricing of these products, particularly for those that received substantial public-sector support in research and development. For example, in 2015, Kite's anticipated base price for the CAR-T axicabtagene ciloleucel was $150,000; however, in 2017, Gilead Sciences acquired Kite for $11.9 billion. When the product received FDA approval, Gilead set an initial launch price of $373,000 and then, in subsequent years, increased this price by more than $50,000.30 At launch, the median price for a year of treatment with a new FDA-approved product increased from $2,115 in 2008 to about $300,000 in 2023.31 As a result of high prices, about one-third report being unable to afford their medications.32 Rising drug costs are passed on to consumers either as out-of-pocket costs or through higher premiums, which makes insurance less affordable and available. Medicaid programs, for example, have had to respond to expanding prescription drug costs by cutting coverage for other services and limiting access to medications.33
In this context, the Inflation Reduction Act of 2022 offered important relief for the health care system by allowing Medicare to directly negotiate prices for certain drugs, just as it negotiates prices with other entities that provide goods or services to the Medicare program, such as hospitals, doctors, and clinical laboratories.34 Negotiation is based on a number of measurable factors, such as whether the drug represents an important therapeutic advance or fulfills an unmet medical need, whether it has recouped its research and development costs, and any federal funding that contributed to its discovery.35 Biologic drugs are only eligible to be sold at negotiated prices once they have been on the market for at least 13 years, during which time manufacturers have been able to earn tens of billions of dollars in US and global sales. Among the first ten drugs negotiated by the Centers for Medicare and Medicaid Services under the IRA in 2024, negotiation led to discounts ranging from 38% to 79% off list prices. Notably, the final prices were still higher than the prices paid for these same drugs in comparable high-income countries around the world.36 One review examining drugs expected to be negotiated in 20262028 found that they accounted for $67.4 billion in Medicare spending and treated conditions such as diabetes, cancer, and cardiovascular disease, suggesting savings and out-of-pocket cost reductions may be achievable for common chronic conditions through negotiation.37
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29 Harvey JP, Raymakers AJN, Rand LZ, Goshua G, Kesselheim AS, Pandya A. Modeling the budgetary impacts of sickle cell disease gene therapies on state Medicaid programs. J Gen Intern Med. 2025 Sep 17.
30 US Senate Health, Education, Labor, and Pensions Committee Majority Staff Report. Public Investment, Private Greed. June 12, 2023.
31 Rome BN, Egilman A, Kesselheim AS. Trends in prescription drug launch prices, 2008-2021. JAMA 2022;327(21):2145-2147; Beasley D. Prices for new US drugs rose 35% in 2023, more than the previous year. Reuters. February 23, 2024.
32 I-MAK. Understanding Americans' top concerns on drug pricing: corporate greed. Oct 2025. Available at: https://reports.i-mak.org/drug-pricing-concerns ("Among the 71% of adults who reported taking prescription medications in the past year, one in three (31%) did not fill at least one prescription due to cost.")
33 Galewitz P. States cut Medicaid drug benefits to save money. Kaiser Health News July 24 2012. Available at: https://khn.org/news/medicaid-cuts-sidebar/
34 This testimony derives in part from testimony that I previously gave to the Energy and Commerce Committee on September 20, 2023. See The Inflation Reduction Act of 2022: reducing excessive spending and Supporting patient access to brand-name drugs while promoting meaningful innovation. Hearing before the House Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce (Rep. Griffith, Chairman). 20 September 2023. United States Congressional Record. Available on-line at: https://energycommerce.house.gov/events/oversight-and-investigations-subcommittee-hearing-1
35 Hwang TJ, Kesselheim AS, Rome BN. New reforms to prescription drug pricing in the US: opportunities and challenges. JAMA 2022;328(11):1041-1042.
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While the IRA was an important step toward curbing excessive drug prices, additional Congressional action is needed to ensure that biotechnology innovations are accessible to the patients who need them. This can be achieved in a few ways. First, Congress should fix the "biologic bonus," the period of 4 years of extra delay in negotiation that applies to biologic drugs beyond the standard 9-year delay for small-molecule drugs. Biologic drugs do not need a delay in qualifying for negotiation. In a recent study published in JAMA38 examining 599 new therapeutic agents approved by the FDA from 2009 to 2023, of which 159 (27%) were biologics and 440 (73%) were small-molecule drugs, we found that median development times were nearly identical for biologics (12.6 years) and small-molecule drugs (12.7 years). In addition, biologics had higher clinical trial success rates at every phase of development. Median development costs were not statistically different, and biologics were protected by a median of 14 patents compared with 3 patents for small-molecule drugs. The median time to follow-on competition was 20.3 years for biologics compared with 12.6 years for small-molecule drugs. Finally, the median annual cost of treatment was $92,000 for biologics and $33,000 for small-molecule drugs. Indeed, biologics had higher median revenues than small-molecule drugs in each year after FDA approval.
In another recent study, focusing on top-selling drugs in Medicare, we found that biologics, on average, earned $7.3 billion more in cumulative revenue than small-molecule drugs during their first 13 years on the market,39 showing how the IRA overly rewards the development of biologics relative to small-molecule drugs. These special legal and regulatory protections for biologics in the US are not justified by differences in development costs or risks, and Congress should therefore align the negotiation timeline for biologics with that of small-molecule drugs.
Second, while the IRA currently limits drug price negotiation to Medicare, these negotiated prices should be extended to benefit all US patients, including those with private insurance. This was initially intended to be included in the IRA before the bill was limited to Medicare by the Senate Parliamentarian.
Third, Congress should ensure that there is direct competition for biotechnology products in a reasonable time frame by preventing manufacturers from amassing large thickets of patents that delay the entry of biosimilars or other products that lead to price reductions.
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36 Rome BN, Kesselheim AS, Feldman WB. Medicare's first round of drug-price negotiation - measuring success. New England Journal of Medicine 2024;391(20):1865-1868.
37 Dickson S, Hernandez I. Drugs likely subject to Medicare negotiation, 2026-2028. J Manag Care Spec Pharm. 2023;29(3):229-235.
38 Wouters OJ, Vogel M, Feldman WB, Beall RF, Kesselheim AS, Tu SS. Differential legal protections for biologics vs small-molecule drugs in the US. JAMA 2024;332(24):2101-2108.
39 Vogel M, Feldman WB, Cowan Z, Rome BN, Chandra A, Kesselheim AS, Wouters OJ. Revenue Differences Between Top-Selling Small-Molecule Drugs and Biologics in Medicare. JAMA Health Forum 2025;6(10):e254720.
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In a review of topselling biologic drugs, we found that they were protected by a median of 8 patents at the time of approval (IQR: 7-20), and the median biologic patent thicket reached a peak density of 41 active patents (IQR: 18-58) at 13 years after approval, of which 76% came from post-approval patents.40 The biosimilar version of etanercept (Enbrel) launched in Europe 13.1 years earlier than the expected US entry; its European patent thicket was over 4-times less dense.41 Such competition can be impactful in lowering prices. We found that in the first year after US entry of biosimilar versions of adalimumab, there was a nearly 50% decrease in adalimumab net spending and prices.42 Strategies for inhibiting excessive patent thickets include revisiting a bipartisan bill in Congress that would have permitted patentees to enforce against generic and biosimilar manufacturers only one patent per group connected by terminal disclaimers,43 or resurrecting a recently abandoned US Patent and Trademark Office (USPTO) proposed rule that would have established that if any claim in a patent is found invalid, all patents linked to it via terminal disclaimer would become unenforceable.44 Congress should also pass legislation to prevent the USPTO from undermining the work of the Patent Trial and Appeals Board, which has been useful in reducing biologic drug patent thickets,45 but has been threatened by recent proposed changes by the new administrators in charge of the USPTO.
It's particularly important for Congress to act because recent administrative announcements on drug pricing are unlikely to result in meaningful reductions in the prices patients actually pay.
First, the administration has announced private deals with some pharmaceutical manufacturers in which the manufacturers promised to introduce future drugs at prices for Medicaid only that are comparable to those in other countries. However, most new drugs are launched first in the US before they have comparable prices in other countries. In addition, Medicaid already gets prices for many brand-name drugs that can approach price levels in other countries because of guaranteed rebates, best price match guarantees, and rebates for price increases over inflation. In these deals, the Trump administration also announced that it would be setting up a website to help manufacturers facilitate direct-to-consumer sales of their brand-name drugs at reduced prices, which generally involves patients paying the manufacturers directly outside of their insurance companies. However, most patients cannot afford to pay out-of-pocket for brand-name drugs that often cost thousands of dollars per month, even at the discounted prices offered through these websites. The overall limited impact of these deals has been made clear as manufacturers' stock prices have tended to remain stable or even increase coincident with these announcements.
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40 Horrow C, Gabriele SME, Tu SS, Sarpatwari A, Kesselheim AS. Patent portfolios protecting 10 top-selling prescription drugs. JAMA Internal Medicine 2024;184(7):810-817.
41 I-MAK. Overpatented, overpriced. Sept 2022. Available at: https://www.i-mak.org/wpcontent/ uploads/2023/01/Overpatented-Overpriced-2023-01-24.pdf
42 Rome BN, Bhaskar A, Kesselheim AS. Use, spending, and prices of adalimumab following biosimilar competition. JAMA Health Forum 2024;5(12):e243964.
43 Peter Welch Press Release. Welch, Braun, and Klobuchar Introduce Bipartisan Legislation to Streamline Drug Patent Litigation, Lower Cost of Prescription Drugs. https://www.welch.senate.gov/welch-braun-andklobucharintroduce-bipartisan-legislation-to-streamline-drug-patent-litigation-lower-cost-of-prescriptiondrugs/.
44 Patent and Trademark Office. Terminal Disclaimer Practice to Obviate Nonstatutory Double Patenting. Notice of Proposed Rulemaking. https://public-inspection.federalregister.gov/2024-10166.pdf.Accessed June 22, 2024).
45 Raymakers AJN, Van de Wiele VL, Kesselheim AS, Tu SS. Changes in biologic drug revenues after administrative patent challenges. Health Affairs 2025;44(3):274-279.
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In addition, Congress should fix its recent move to pass legislation as part of the One Big Beautiful Bill Act (OBBBA) that expanded the rare disease exclusion in the IRA. The IRA had made drugs approved exclusively for a single rare disease exempt from negotiation. But the OBBBA expanded this "sole orphan" exclusion to cover drugs FDA-approved for more than one rare disease indication, and it delayed the start of the 7- or 11-year negotiation period for drugs first approved for a rare condition until the date they later receive approval for a non-rare condition. These steps will unnecessarily limit the number of drugs eligible for Medicare price negotiation. In a previous analysis, we found that among the nearly 300 drugs with over $200 million in Medicare sales from 2012-2021, 20 drugs were multi-orphan drugs and 13 were orphan-first drugs that would be affected by the proposed expanded carve-outs; these drugs collectively accounted for $183 billion in Medicare drug spending.46
Under OBBBA, the blockbuster cancer drugs pembrolizumab (Keytruda) and nivolumab (Opdivo) will be exempt from negotiation for an additional year, and in 2023 the Medicare spent over $7 billion on these two drugs alone.47 The Congressional Budget Office recently concluded that this change could cost the health care system $8.8 billion over the next decade. Instead, Congress should pass the recently-introduced No Big Blockbuster Bailouts Act (NOBBBA), which allows rare disease-designated drugs that account for $400 million per year or more in Medicare sales to be eligible for negotiation.48 We should not worry about this bill taking away incentives for investment in rare disease biotechnology products, because when weighing the prospect of earning over $400 million in Medicare against the possibility that under the IRA, Medicare will seek to negotiate a fair price for the drug that would be higher than in other settings around the world and that would take effect about a decade after FDA approval, a rational biotech company would still seek to pursue this investment.
Finally, making biotechnology innovation available to patients also requires that patients have adequate insurance coverage, but the government has moved in recent months to reduce enrollment in Medicaid and is currently poised to allow insurance marketplace premiums to soar to levels beyond what many patients can pay. In addition to seeking fair prices for biotechnology products, making affordable insurance available to as many people as possible can help ensure that innovative biotechnology products reach the patients who need them.
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46 Vogel M, Zhao O, Feldman WB, Chandra A, Kesselheim AS, Rome BN. Cost of exempting sole orphan drugs from Medicare negotiation. JAMA Internal Medicine 2024;184(1):63-69.
47 Mooney H, Kesselheim AS, Rome BN. Congress should remove the rare disease carve-out from Medicare drug price negotiation, not expand it. Health Affairs Forefront. June 30, 2025. Available on-line at: https://www.healthaffairs.org/content/forefront/congress-should-remove-rare-disease-carve-out-medicaredrugprice-negotiation-not
48 See bill at: https://www.welch.senate.gov/wp-content/uploads/2025/10/Bill-Text-No-Big-Blockbuster-BailoutsAct-Welch-20251021.pdf.
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Original text here: https://www.help.senate.gov/imo/media/doc/77287bdb-084f-c84c-7a93-3624e7471c2a/Kesselheim%20Testimony.pdf
Disabled American Veterans Deputy National Legislative Director Retzer Testifies Before Senate Veterans' Affairs Committee
WASHINGTON, Nov. 13 -- The Senate Veterans' Affairs Committee issued the following testimony by Jon Retzer, deputy national legislative director of Disabled American Veterans, from an Oct. 29, 2025, hearing entitled "Putting Veterans First: Is the Current VA Disability System Keeping Its Promise?":* * *
Chairman Moran, Ranking Member Blumenthal and members of the Committee:
Thank you for inviting DAV (Disabled American Veterans) to testify today about the Department of Veterans Affairs (VA) disability compensation program, its vital role in supporting veterans, their families and survivors, ... Show Full Article WASHINGTON, Nov. 13 -- The Senate Veterans' Affairs Committee issued the following testimony by Jon Retzer, deputy national legislative director of Disabled American Veterans, from an Oct. 29, 2025, hearing entitled "Putting Veterans First: Is the Current VA Disability System Keeping Its Promise?": * * * Chairman Moran, Ranking Member Blumenthal and members of the Committee: Thank you for inviting DAV (Disabled American Veterans) to testify today about the Department of Veterans Affairs (VA) disability compensation program, its vital role in supporting veterans, their families and survivors,as well as the challenges VA faces in providing timely and accurate decisions on veterans claims for these and other benefits.
As you know, DAV is a congressionally chartered, VA-accredited, nonprofit veterans service organization (VSO) with nearly a million members, all of whom are wartime service-disabled veterans. We are dedicated to a single purpose: empowering veterans to lead high-quality lives with respect and dignity. To fulfill our service mission assisting veterans, their families, caregivers and survivors seeking benefits earned as a result of their military service, DAV has over 4,200 chapter, department, transition and national service officers (NSO) nationwide; including DAV accredited county veterans service officers.
There are over 1.1 million veterans and their survivors who have chosen DAV to be their representative before the VA, more than any other organization. Last year, we helped veterans file over 560,000 claims for benefits to the Veterans Benefits Administration (VBA), taking over 3.1 million actions to support them. This assistance, like all of DAV's charitable services, was provided at no charge to veterans and their families, and DAV receives no compensation of any kind from the government for providing these services.
Drawing on the collective experience and expertise of our benefits experts, I am pleased to have the opportunity to share our observations and recommendations to improve the VA disability compensation processing system; however, we feel it necessary to first set the record straight on the outrageously misleading and highly inaccurate stories that The Washington Post recently published.
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Setting the Record Straight on The Washington Post Story
Mr. Chairman, DAV was shocked and disgusted to read the Post article alleging that disabled veterans are "swamping" the VA with "false", "fraudulent" and "dubious" disability claims for injuries and illnesses that the Post considers illegitimate. Nothing could be farther from the truth, and the Post should be ashamed of publishing such an inaccurate and distorted piece.
For example, the Post argues that disabled veterans are, "...swamping the U.S. government with dubious disability claims..." when, in fact, according to the VA Office of Inspector General, there have been fewer than 200 fraud convictions annually in recent years. With VBA processing almost 3 million claims in the most recent fiscal year, that equates to a fraud rate of less than 1/100th of 1%. We certainly acknowledge that there are other cases of fraud that have not yet or may never be caught, and we hope that every one of those individuals involved, many of whom are not veterans, are prosecuted to the fullest extent of the law.
However, in order to justify their conclusion that VA is "swamped" with illegitimate claims, the Post dishonestly combines cases of "fraud" with what they allege are "exaggeration" and "dubious" claims for disability compensation. By categorizing a number of disability claims as "dubious", the Post seeks to delegitimize numerous conditions that can be quite serious, including eczema, tinnitus, pain, hypertension, diabetes, depression and other mental health conditions, each of which Congress and/or VA have determined can result from military service. The Post appears to have no understanding of what veterans with chronic and severe cases of tinnitus, eczema, pain and other so-called minor conditions have to overcome, not just to work, but to lead as normal a life as possible. Nor do they seem aware that hypertension and diabetes have been scientifically and medically linked to toxic hazards, such as Agent Orange, a chemical herbicide that millions of veterans were exposed to in Vietnam. Perhaps most shocking was the Post's references to depression and other mental health conditions - even post-traumatic stress disorder (PTSD) - as among those they consider "exaggeration" and "dubious" conditions.
Without citing data or other objective evidence, the Post also asserts that "Congress and VA have made it easier to cheat and take advantage of the system." The story points to the enactment of legislation such as the Sergeant First Class Heath Robinson Honoring our Promise to Address Comprehensive Toxics (PACT) Act of 2022 (P.L. 117-168) and the Veterans Appeals Improvement and Modernization Act (AMA) (P.L. 115-55), two landmark laws purposely designed by Congress to make it easier for veterans to receive earned benefits that have too often been delayed or denied in the past. It is a gross mischaracterization to imply that these laws make it easier for criminals to steal taxpayer dollars, rather than recognize how they have fundamentally improved the ability of millions of veterans to receive justice and due process.
One of the most important but often overlooked strengths of the current VA disability compensation system is that disabled veterans are incentivized to continually improve their health and well-being in order to pursue meaningful employment and entrepreneurship. The Post apparently believes that even severely disabled veterans - those who have lost limbs, are blind or paralyzed - only merit disability compensation when they are unable to work. The Post fails to recognize all the time and effort it may take for these men and women to overcome such disabilities, the impact on the families and the other parts of their lives, including how it often shortens their lives.
The Post displays a stunning ignorance about how the VA benefits system actually works by referencing it as an "honor system" that they argue is ripe for fraud. Clearly, the Post does not understand what is required under current laws and regulations to establish direct service connection for a disability, a prerequisite for veterans to receive disability compensation. First, there must be verified evidence of a current VA-recognized disability, typically from a medical diagnosis. Second, there must be sufficient evidence of an in-service incident or exposure that could have caused or aggravated the disability, such as a toxic exposure, military accident or combat wound. Third, there must be authoritative evidence of a nexus between the current disability and the incident or exposure, usually established by a competent medical opinion. Contrary to what the Post implies, VA does not just "take the veterans word"; instead, in most circumstances, veterans must have sufficient evidence on all three points, which most of the people here today have probably heard many times before, can be a complicated and time-consuming process.
However, in order to support its preordained conclusions, the Post ignores how VA normally adjudicates claims for direct service connection and instead focuses on certain exceptions that have different rules due to some unique circumstances that occur during military service. For example, veterans who have mental health issues arising from military sexual trauma (MST) often have great difficulty assembling evidence that such incidents occurred. This is particularly true for veterans who don't come to grips with the devastating impact of that trauma until many years later. Too often, MST survivors don't document what occurred while on active duty due to the stigma associated with sexual assault or sometimes out of fear of reprisal from the perpetrators or others in the military chain of command. For these reasons, MST claims recognize victim statements or contemporaneous markers in the veteran's medical records that are consistent with MST as sufficient evidence of the incident.
Another significant category of claims that sometimes have special rules are related to diseases and conditions caused by military toxic exposures and environmental hazards, an issue that Congress and successive Administrations have placed greater focus on in recent years, culminating with the passage of the PACT Act in 2022. Over the past three decades, radiation, Agent Orange, burn pits and other toxins and hazards have been increasingly linked by scientific and medical studies to a range of diseases and conditions, including diabetes, heart disease, hypertension, cancers and respiratory conditions. However, many of these harmful health impacts don't manifest until years or decades after veterans were exposed, making it exceedingly difficult for a veteran to produce proof that they were exposed to a specific toxin or chemical at a specific time and location, particularly for those deployed in combat zones.
To address these types of evidentiary challenges, Congress and VA created an alternate mechanism - known as presumptive service connection - to provide justice to groups of veterans injured by toxic exposures. For example, it would be virtually impossible to know exact locations and times where Agent Orange was used in Vietnam and other southeast Asia locations, much less exactly how wind patterns dispersed it, just as it would not be feasible to prove the exact location of every service member in country during those years. However, there is more than adequate proof that Agent Orange exposure was widespread enough to reasonably conclude that it makes sense to concede, or "presume," that every veteran who served in Vietnam during those years Agent Orange was used was exposed to it.
For these reasons, Congress approved the Agent Orange Act of 1991 (P.L. 102-4), which created a presumption of service connection for diseases and conditions associated with Agent Orange exposure. This not an "honor system" but a fact-based policy determination that provides veterans with the benefit of the doubt. Furthermore, the Post's belief that diseases like diabetes and hypertension should never be linked to military because civilians also get those diseases discounts decades worth of studies documenting both statistical association and causal relationship.
Mr. Chairman, these are just some of the most outrageous misrepresentations put out by the Post in recent weeks, and we would be more than willing to address any other issues that the Committee or Senators would like us to address.
In our view, this story was neither investigative news reporting nor analysis - it was a longform editorial developed from a preconceived conclusion that they then tried to support with a series of misleading and conflated statistics, anecdotal quotes transformed into generalizations, unsupported assertions and a near total misunderstanding about the history, purpose and functioning of the VA disability compensation system.
However, while we greatly appreciate this opportunity to set the record straight on the misrepresentation of reality published by The Washington Post, we are more interested in sharing our perspectives and recommendations on how to strengthen the VA claims process that millions of veterans, their families, caregivers and survivors rely on.
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Improving VA's Claims Processing System for Disabled Veterans
Almost two decades ago, after Congress created the Veterans Disability Benefits Commission to explore whether major changes were needed to VA's benefit programs, one of my DAV predecessors testified that the disability compensation system was:
"...fundamentally sound and the most practical approach to the complex task of fairly compensating a large number of veterans for whom the effect of disability is as diverse as the demographic and socioeconomic characteristics of the members of the military force and the citizens of our nation from which those members come."/1
DAV continues to believe that is true in terms of the purpose and structure of VA disability compensation benefits; however, we also believe that Congress and VA must continue to reform and improve the processes used to adjudicate veterans' claims for benefits to ensure they receive the most accurate and timely decisions possible. Accordingly, we make the following recommendations.
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Ensure VA has the resources to ensure accuracy and timeliness of claims
Since the enactment of the PACT Act in August 2022, VBA has seen a tremendous influx of new claims for benefits related to toxic exposures. This increase comes on top of numerous efforts by VA to expand outreach to veterans over the past decade, often focused on connecting with veterans in crisis or at risk of suicide. As a result, the backlog of claims pending more than the standard of 125 days rose significantly in recent years. When the PACT Act was signed into law, the backlog was just over 150,000 claims. It steadily rose over the next year and a half to a peak of over 400,000 backlogged claims in January 2024, before it began to drop as VBA increased staffing and other resources significantly, falling to about 250,000 in January 2025, and it is now down to 135,000 as result of all the new employees being fully trained and more productive.
However, given the long history of VBA backlogs, we must never be complacent. Earlier this year, DAV and our partners in The Independent Budget (Paralyzed Veterans of America, Veterans of Foreign Wars) recommended that funding for VBA claims processing in FY 2026 be increased by at least $300 million to support additional overtime and enhanced mail processing capabilities. We are aware that VBA has required mandatory overtime for claims processers to increase production this year; however, we are concerned if VBA's staffing levels end up being reduced by the attrition and voluntary retirements VA announced earlier this year, they could drop below the level needed to maintain the record levels of production in each of the past three years. The use of mandatory overtime is an important tool VBA can use to increase production for limited durations, but if overused it can lead to employee burnout and lower accuracy in claims decisions. We urge the Committee to closely monitor staffing levels at VBA, particularly how they have been affected by VA's announced 30,000 FTE force reduction, to ensure there are adequate resources to process veterans claims quickly and accurately.
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1 Testimony of Rick Surratt, DAV Deputy National Legislative Director, before the Committee on Medical Evaluation of Veterans for Disability Compensation of the Institute of Medicine, July 7, 2006.
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Simplify procedures for veterans filing benefit claims
Over the past decade, there have been a number of statutory and regulatory changes enacted to streamline various aspects of the VA claims processing and appeals systems, including the landmark Veterans Appeals Improvement and Modernization Act (AMA), which DAV and other VSOs worked closely with Congress and VA to develop and enact. We believe the AMA has largely been successful; however, there remain a number of implementation decisions by VBA that have made the claims filing process more difficult for veterans and sometimes threatens their ability to receive the benefits they are due. Below are several changes DAV recommends to improve the process for veterans.
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Veterans should be able to file claims by phone
The AMA requires veterans to file claims only with specific VA forms, which includes the ability to file an Intent To File (ITF) form to guarantee the earliest effective date for a claim. VA allows a veteran to submit an ITF by phone, but not a formal claim, such as for an increased evaluation or secondary condition. Before enactment of AMA, nearly all claims for benefits could be filed by phone, with the exception of an initial claim, which required some version of the VA Form 21-526EZ.
We believe a veteran should be able to contact the VA by phone and file a claim for any condition at any time by verbalizing to the VA the necessary information, just as they can for an ITF. There is no substantive reason why VA cannot accept claims verbally over the phone.
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End VA's requirement that claims will only be accepted using specific forms
Currently, the VA treats claims filed on an "incorrect form" merely as a request for a claims application. If and when the correct application is subsequently received at VA, the effective date of the claim and benefit payment ends up being is later than the receipt of the previously submitted "incorrect form." If a favorable decision is ultimately rendered, the monetary amount is likely to be less as a result of the delayed effective date. Furthermore, in the current process, if an ITF is of record and if an "incorrect form" is later received, the ITF could be associated with the "incorrect form," and what might be a much earlier effective date could be lost.
To remedy this situation, VA should accept any filing made by a veteran for benefits as a clear statement of the veteran's "Intent To File" a claim and protect that effective date. Further, VBA should require that claims processors infer that the claimant intends to have filed the type of claim that provides the greatest benefit under the law using the concept of reasonable doubt in 38 C.F.R. Sec.Sec. 3.102 and 4.3. Accordingly, whether a claim was submitted on a VA Form 21-526EZ or a VA Form 20-0995, claims processors should construe the claim in a manner that maximizes the veteran's benefits.
While we are aware of VA's interest in maximizing efficiency in its claims processing system, that should not come at the expense of veterans losing part of their earned benefits. As will be discussed below, we believe that the use of advance technologies and artificial intelligence (AI) may ultimately be able to bridge this gap, but until such time, VA's rules should favor the interests of the veteran over bureaucratic efficiency.
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Claimants should not be required to identify benefit sought
Another requirement that often delays benefits to veterans is the requirement that they must specifically identity the benefit (or benefits) sought. On Form 21-0966, Section III, block 19, requires the claimant to check a block for "all that apply," and then lists Compensation, Pension, Survivors Pension and/or Dependency and Indemnity Compensation (DIC) as options. This can become a problem in certain situations, such as when veteran applies for disability compensation, but only qualifies for nonservice-connected pension. In this situation, after they are denied disability compensation, they must reapply for pension benefits; however, due to the block 19 requirement, the VA will not protect the earliest effective date unless they checked both boxes. We believe that the requirement to identify the general benefit under 38 C.F.R. Sec. 3.155(b)(2) should be removed.
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Optimize the use of technology, particularly AI technologies
In order to efficiently improve both productivity and accuracy, VBA must continue to maximize and optimize the use of advanced technology, including artificial intelligence. In particular, VBA should invest in new document digitization and data mining systems that will allow it to receive benefit applications and evidence from veterans and can then transform that data so it can be used in any format necessary to process and adjudicate claims and appeals. When VA reaches this level of automation, many of the procedural barriers discussed above about VA forms and requirements will become moot in terms of administrative efficiency, making it easier for veterans to more quickly receive their full benefits.
However, we caution that VBA needs to prudently explore and utilize advanced AI to support rating decision-making and notifications to veterans. AI can play a significant role both increasing speed and reducing errors, but only if it is properly implemented and monitored. Therefore, it is critical that VBA develop procedures and guardrails, most importantly related to training and quality control programs that can systematically ensure that essential organizational knowledge and expertise is preserved. AI and other advanced information technologies must always serve the purpose and people inside VBA, not become a replacement for either.
Finally, VBA must continue to develop and prioritize new IT systems to support VSO partners to efficiently file claims and appeals online. Earlier this year in September, without consulting DAV or other major accredited VSOs, VBA announced the imminent launch of a new IT system for use by VSOs - the Accredited Representative Portal (ARP) - which would replace the Stakeholder Enterprise Portal (SEP) that many VSOs, including DAV, have successfully used for years. Unfortunately, once we became aware of the new ARP system, we quickly discovered that, as currently designed, it would not effectively integrate with our internal systems and operations that assist veterans in filing claims and appeals for VA benefits. We have had some initial conversations with VA IT staff about these problems but remain concerned that the planned phasing-out of SEP by the end of 2025 will negatively impact the ability of DAV and other accredited VSOs to support veterans, their families, caregivers and survivors we collectively represent.
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Continue to strengthen presumptive decision-making processes for toxic and environmental exposure claims
Another way to improve the process and outcomes for veterans filing benefit claims, one that will also make VA more efficient, is to strengthen presumptive decision-making processes for claims arising from military toxic exposures and environmental hazards. Enactment of the PACT Act was truly a generational victory for veterans who have to wait for decades to receive benefits related to diseases and conditions caused by burn pits and other toxic exposures. Last September, together with the Military Officers Association of America (MOAA), we released a groundbreaking report: Ending the Wait for Toxic-Exposed Veterans, A post-PACT Act blueprint for reforming the VA presumptive process. Our research found that on average, it takes over 30 years from the first time a dangerous military toxic exposure is first encountered by service members until Congress or VA creates a presumptive condition to fully recognize and compensate veterans for illnesses and disabilities related to that exposure. Among the most well-known examples of presumptives are for Atomic Veterans exposed to ionizing radiation; Vietnam veterans exposed to Agent Orange; and Persian Gulf War, Iraq and Afghanistan veterans exposed to myriad toxins from burn pits.
The expanded use of presumptives to overcome evidentiary gaps associated with toxic exposures not only benefits veterans who have been forced to wait far too long for justice; it uses VBA resources more efficiently by consolidating certain evidentiary decisions for cohorts of veterans defined by the time and location of their service, as well as common toxic exposures that have been scientifically linked with certain diseases and illnesses. While the PACT Act was a historic victory for veterans, it did not include all toxic substances that veterans have been exposed to, nor does it cover all future exposures and hazards that service members may encounter. For those reasons, DAV and MOAA produced the Ending the Wait report, which includes a number of recommendations to create a more effective presumptive decision-making process. The report contains several other critical recommendations to ensure toxic-exposed veterans don't have to wait decades for justice, which include: expanding federal research on toxic exposures; creating an independent scientific review process for diseases caused by toxic exposures; and establishing a veterans' stakeholder advisory commission to strengthen oversight and transparency of the VA presumptive-making process.
Mr. Chairman, we are truly grateful for the work that you and others on the Committee did to pass the PACT Act; however, there is still more work to be done. Working together we can build upon the foundation created by the PACT Act by implementing the recommendations in our report, which we believe will not only help end the wait for toxic-exposed veterans but also make the VA claims processing system fairer, faster and more efficient.
This concludes my testimony, and I would be happy to answer any questions that you or members of the Committee may have.
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Original text here: https://www.veterans.senate.gov/services/files/2DC635E4-9E59-474C-AC62-6899A3A993A4