Congressional Testimony
Congressional Testimony
Here's a look at documents involving congressional testimony and member statements
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Under Secretary of Agriculture for Trade & Foreign Agricultural Affairs Lindberg Testifies Before House Appropriations Subcommittee
WASHINGTON, March 11 -- The House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies released the following testimony by Luke Lindberg, under secretary of Agriculture for trade and foreign agricultural affairs, from a March 6, 2026, hearing on the oversight of the agency:* * *
Good morning, Chairman Harris, Ranking Member Bishop, and Members of the Subcommittee.
Thank you for the opportunity to appear before you today on behalf of President Trump, Secretary Rollins, and the U.S. Department of Agriculture. I am Luke Lindberg, Under ... Show Full Article WASHINGTON, March 11 -- The House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies released the following testimony by Luke Lindberg, under secretary of Agriculture for trade and foreign agricultural affairs, from a March 6, 2026, hearing on the oversight of the agency: * * * Good morning, Chairman Harris, Ranking Member Bishop, and Members of the Subcommittee. Thank you for the opportunity to appear before you today on behalf of President Trump, Secretary Rollins, and the U.S. Department of Agriculture. I am Luke Lindberg, UnderSecretary for Trade and Foreign Agricultural Affairs, where I oversee the Trade and Foreign Agricultural Affairs mission area, including the Foreign Agricultural Service and the U.S. Codex Office.
When President Trump first nominated me for this position, he said, "Luke is going to get us smart trade deals for our farmers." President Trump's Make America First trade agenda and USDA's trade strategy is guided by a clear objective: get America's agricultural trade deficit back to surplus and bring reciprocity and fairness back to America's farmers, ranchers, and agricultural producers. We are executing this strategy through a targeted approach focused on three pillars: securing better deals, strengthening buyer-seller relationships, and holding our trading partners accountable.
First - Securing Better Deals
For over fifty years, America enjoyed an agricultural trade surplus with other countries. It wasn't until the Biden Administration, after signing zero new trade deals and not holding other countries accountable to prior commitments, that America experienced a sharp pivot towards years of growing U.S. agricultural trade deficits, to the tune of $50 billion. This further squeezed Biden's broken farm economy, which also saw 30% higher input costs.
Further, America had historically been treated unfairly by some of our trading partners. The U.S. maintains some of the lowest applied agricultural tariffs in the world, while many of our major trading partners maintain significantly higher tariffs and impose egregious non-tariff barriers that restrict market access. For example, India, the European Union, and the United Kingdom, all apply higher average tariffs on imports than America.
Fortunately, the Trump Administration has restored an America first approach to U.S. agricultural trade. President Trump is the ultimate Dealmaker in Chief, and American farmers have already benefitted directly from his leadership in our trading relationships.
I like to say that exporting is a team sport, and that couldn't be more true than in this Administration. American farmers and ranchers are blessed to have not just USDA, but the trade negotiators at the Office of the U.S. Trade Representative, and support from our partners at the Department of Treasury, the Department of Commerce, U.S. Department of State, and the rest of the interagency, all prioritizing American agriculture on the world stage.
One year into this Administration, I want to provide a clear report card. Across regions and commodities, we are seeing concrete progress in reversing the U.S. agricultural trade deficit.
In Central America, agreements with El Salvador and Guatemala have removed unnecessary fumigation requirements, streamlined certification, mandated science-based inspection practices, and created new demand for U.S. ethanol, including a 50-million-gallon annual purchase commitment by Guatemala.
In South America, Argentina has committed to opening access for U.S. poultry within one year, simplifying red tape for beef and pork exports, and protecting U.S. exporters' use of certain meat and cheese terms -- a critical issue for value-added exporters.
In Asia, progress has been substantial in the form of trade frameworks and reciprocal trade agreements, which we are closely monitoring:
* Japan committed to $8 billion in U.S. agricultural purchases, including corn, soybeans, ethanol, fertilizer, and sustainable aviation fuel, and agreed to increase imports of U.S. rice by 75 percent under its WTO minimum access tariff rate quota.
* Vietnam has committed to expand access for U.S. meats and specialty cheeses, improve access for U.S. peaches and nectarines, and accept clearer tariff disciplines on U.S. agricultural goods.
* South Korea has committed to streamline biotech approvals, preserve access for U.S. meat and dairy products, and establish a dedicated U.S. desk to resolve horticultural access issues.
* Thailand committed to eliminating tariffs on 99 percent of U.S. goods, made a $2.6 billion annual purchase commitment for feed grains and distillers grains, and addressed longstanding ethanol and horticultural barriers.
* Malaysia, Indonesia, Cambodia, and the Philippines have taken concrete steps to reduce or eliminate tariffs, recognize U.S. food safety systems, and remove non-tariff barriers that have historically slowed U.S. exports. In Indonesia specifically, recent engagements have focused on improving regulatory transparency.
* Taiwan committed to provide preferential market access for a wide range of U.S. agricultural exports. It also committed to resolve and prevent non-tariff barriers to U.S. agricultural products, including beef, pork, poultry, and processing potatoes, and to preserve current and future U.S. market access for U.S. cheese and meat producers who rely on the use of certain names.
With China, agriculture has remained a stabilizing force in the broader relationship.
Commitments on soybeans, sorghum, and other agricultural commodities are being met, with significant purchases of U.S. soybeans following high-level engagement in October. We are continuing to work to ensure agriculture remains a central deliverable in future discussions.
In Europe, we have made measurable progress addressing tariffs, and in the United Kingdom, we secured expanded access for American beef and established a 1.4-billion-liter ethanol tariff-rate quota under the framework agreement -- creating substantial new export potential for U.S. producers.
On the U.S.-Mexico-Canada-Agreement Joint Review, we are also working closely with the Office of the U.S. Trade Representative to ensure the Agreement remains in the interest of American farmers, ranchers, and producers. The Joint Review presents an opportunity for the United States to consider how the USMCA is working and address shortcomings, including for U.S. agriculture.
These are not abstract commitments. They are tariff reductions, purchase commitments, restored market access, and regulatory reforms that are translating into measurable export gains. In just one year, the agricultural trade deficit is now forecasted at $29 billion. That's an $8 billion improvement from December 2025 and a $14.7 billion improvement from fiscal year 2025.
Second - Strengthening Buyer-Seller Relationships
Trade agreements alone do not generate sales. Market access must be converted into commercial relationships.
To ensure that happens, Secretary Rollins and I launched a three-point plan to operationalize new trade opportunities.
First, we established the America First Trade Promotion Program, which provides targeted trade promotion resources in non-traditional and high-growth markets. This complements USDA's longstanding agricultural trade promotion and facilitation programs and enhances trade promotion for exporters pursuing newly opened markets.
Next, we deployed Trade Reciprocity for U.S. Manufacturers and Producers (TRUMP) missions - which complement our existing agribusiness trade missions and place American producers directly in markets where agricultural trade frameworks have been secured.
For example:
* In the United Kingdom, following the framework agreement that established a 1.4billion-liter ethanol tariff-rate quota and new beef access, Secretary Rollins and I led a TRUMP mission that brought U.S. industry representatives directly to buyers to operationalize those openings.
* Traditional agribusiness trade missions in 2025 generated 2,755 business-to-business meetings and an estimated $124.8 million in projected sales over the following year.
* Our most recent agribusiness trade mission in February to Indonesia connected U.S. producers with buyers across corn, soy, wheat, cotton, and fresh fruit sectors in one of our fastest-growing markets.
* We hosted the largest ever trade mission last Fall to Mexico with more than 150 U.S. participants, connecting willing buyers and willing sellers, complementing USDAMarketing and Regulatory Program's work in evaluating the state of New World Screwworm, and working with our interagency partners to secure the greatest win for America under the 1944 U.S.- Mexico Water Treaty, since its inception.
Lastly, we are working to modernize export financing through the GSM-102 Export Credit Guarantee Program. We recently expanded repayment flexibility with a new 18-month option that aligns with industry practices and improves competitiveness in Africa, the Middle East, and Asia.
These tools ensure that when we negotiate access, American producers are positioned to capture demand quickly and effectively.
And finally, - Holding Partners Accountable
Reciprocity requires enforcement.
USDA works in close coordination with USTR to monitor compliance and respond rapidly when commitments are not honored. I meet regularly with Ambassador Callahan to align on enforcement priorities and ensure agricultural interests remain central for U.S. trade policy.
FAS maintains nearly 100 overseas offices staffed by trade specialists and market analysts who provide real-time intelligence and serve as a rapid-response team when barriers arise.
We have demonstrated this accountability approach in several instances:
* Resolving Pakistan's soybean import restrictions.
* Pressing Brazil on fair treatment for U.S. ethanol, including with respect to carbon credit treatment.
* Urging Canada to not disadvantage U.S. biofuels, including ethanol, in its policy making.
* Restoring South African market access for popcorn.
We are holding implementers of our programs accountable, too. USDA just announced its intention to utilize $452 million worth of fiscal year 2025 funds for a Food for Peace agreement to feed the hungry with America's bounty. We are in return asking implementers to purchase 100% American grown commodities, work towards a no "forever aid" model, and institute strict accountability and oversight measures.
Holding partners accountable ensures that negotiated commitments translate into sustained commercial opportunity and prosperity.
Conclusion
The Trump Administration has been hard at work putting farmers first, delivering timely assistance, securing 18 trade deals and frameworks, and working to reduce the inherited and unprecedented U.S. agricultural trade deficit. While the agricultural trade deficit remains a serious concern, addressing it requires disciplined execution across negotiation, promotion, and enforcement.
Under President Trump's leadership and Secretary Rollins' direction, USDA has made great strides. We will continue using every available tool - trade promotion, export financing, food assistance programs, and coordinated interagency enforcement - to expand market access and improve the competitive position of American agriculture.
Thank you for your continued support of USDA. I look forward to your questions.
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Original text here: https://docs.house.gov/meetings/AP/AP01/20260304/119009/HHRG-119-AP01-Wstate-LindbergL-20260304.pdf
New America Future of Work & Innovation Economy Initiative Managing Director Jyotishi Testifies Before House Appropriations Subcommittee
WASHINGTON, March 11 -- The House Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies released the following testimony by Shalin Jyotishi, managing director and founder of the Future of Work and Innovation Economy Initiative at New America, from a March 4, 2026, hearing entitled "Preparing for the Future: America's Community Colleges":* * *
Thank you, Chairman Aderholt, Ranking Member DeLauro, and members of the Committee, for the privilege to speak with you about the vital role community colleges play in preparing for the future and expanding access ... Show Full Article WASHINGTON, March 11 -- The House Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies released the following testimony by Shalin Jyotishi, managing director and founder of the Future of Work and Innovation Economy Initiative at New America, from a March 4, 2026, hearing entitled "Preparing for the Future: America's Community Colleges": * * * Thank you, Chairman Aderholt, Ranking Member DeLauro, and members of the Committee, for the privilege to speak with you about the vital role community colleges play in preparing for the future and expanding accessto economic security, the American middle class, and the American Dream.
My name is Shalin Jyotishi, and I lead the Future of Work & Innovation Economy initiative at New America. Our mission is to ensure that technological innovation and tech-based economic development translate into economic security for American workers and their families. Community colleges are central to that mission.
Our nation's more than 900 community colleges enroll about 40% of all undergraduate students. They disproportionately serve low-income students: Nearly 57% of their students come from households earning below 200% of the federal poverty level./1
Through apprenticeships and work-based learning, career and technical education, and other workforce credentials, community colleges offer affordable, accessible, and industry-aligned pathways to the jobs that keep our communities running in healthcare, public safety, skilled trades, manufacturing, IT, and more.
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1 https://sgp.fas.org/crs/misc/R45686.pdfrunning
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But increasingly, rapid advances in emerging technologies such as artificial intelligence have meant that community colleges must prepare students for a much more complex labor market. From coast to coast, colleges are expanding training programs focused on AI,/2 biotechnology,/3 microelectronics,/4 energy innovation, and advanced manufacturing to promote economic development and meet industry needs.
More than half of America's 36 million STEM workers belong to the "skilled technical workforce," meaning they need education beyond high school, but not necessarily a bachelor's degree./5
Community colleges are critical to educating this population. These workers tend to outearn peers with similar levels of education in non-STEM sectors, and they represent a bedrock of America's middle class and our key to continued and expanded economic prosperity and standard of living.
But community colleges are facing this responsibility while contending with long-standing underinvestment. Despite their focus on serving low-income students, they receive much less public funding per student compared to four-year institutions./6
If we expect our community colleges to deliver strong workforce outcomes in our most advanced industries and during this period of accelerated technological change, they will need targeted and strategic investments to position them for success.
In September 2024, New America partnered with the U.S. National Science
Foundation (NSF) to launch the Accelerator for Community Colleges in the Innovation Economy. A first-of-its-kind effort to provide capacity-building technical assistance to community colleges located in regions where tech-based economic development is concentrated. It is funded by private philanthropy and supported by a national network representing governors, mayors, businesses, community college presidents and trustees, workforce development boards, and research universities./7
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2 https://www.newamerica.org/education-policy/edcentral/whats-new-in-ai-focused-skilled-technical-wor kforce-education/
3 https://www.forbes.com/sites/shalinjyotishi/2022/11/10/biotechnology-industry-gets-a-boost-from-com munity-college-degrees/
4 https://micronanoeducation.org/about/
5 https://ncses.nsf.gov/pubs/nsb20245
6 https://www.ccdaily.com/2025/10/datapoints-revenue-by-source/
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Drawing on our analysis and direct work with colleges, I offer the following recommendations for the committee to better leverage the Department of Education (ED) and the Department of Labor (DOL) to build community colleges for advanced and emerging technology industries: First, ED and DOL should be given the resources and mandate to deepen collaboration with federal agencies advancing R&D and economic
development in emerging technology areas of national interest,/8 including the National Science Foundation, Department of Commerce, Department of Energy, the White House Office of Science & Technology Policy, and other agencies./9
These collaborations should focus on a) identifying the sectors aligned with national priorities, including national security and rural development; b) identifying the regions of priority for capacity-building investments, given ongoing federal and private sector activity; and c) coordinating relevant workforce funding opportunities for community colleges.
These actions would align with the administration's AI Action Plan, which has already called for Departments of Labor, Education, Commerce, and the NSF to "prioritize AI skill development as a core objective of education and workforce funding streams."/10
For illustration, the NSF's Advanced Technological Education (ATE) program has generated many best practices in community college capacity-building for advanced industries. NSF ATE funds the National Applied AI Consortium led by Miami Dade College, Houston Community College, and Maricopa Community College District.
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7 https://www.newamerica.org/education-policy/press-releases/nsf-and-new-america-announce-strategicinitiative-to-empower-community-and-technical-colleges/; https://www.newamerica.org/education-policy/edcentral/empowering-community-colleges-partnerships -for-economic-development-and-indeffectivelyfirst fiveustrial-policy/
8 https://www.nsf.gov/focus-also areas/technology
9 Including the Defense Advanced Research Projects Agency, Advanced Research Projects Agency for Health, and the Advanced Research Projects Agency for Infrastructure.
10 https://dcjournal.com/how-community-colleges-can-realize-the-promise-of-ai-action-plan/
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This consortium has partnered with Microsoft, Google, Intel, OpenAI, and other leading tech companies to support nearly 2,000 faculty and staff across more than 300 community colleges spanning 49 states to scale AI education./11
There is much DOL and ED can learn and scale in collaborating with agencies closest to R&D and tech-based economic development,/12 as as part of this mandate, they should report their collaborations back to Congress for further evaluation and refined coordination.
Second, DOL and ED should be given the resources to accelerate community college capacity-building in advanced and emerging industries.
DOL's Strengthening Community Colleges Training Grants (SCCTG) program would be a good existing funding vehicle./13
An expanded, targeted allocation for colleges focused on advanced and emerging industries and in regions poised to see the most tech-based growth would go a long way. Additionally, the Carl D. Perkins National Activities appropriation could also be harmonized with SCCTG funding to achieve this goal.
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11 https://www.forbes.com/sites/shalinjyotishi/2026/02/25/openai-google-microsoft-intel-bet-on-commu nity-colleges-for-ai-talent/
12 https://www.newamerica.org/education-policy/edcentral/energy-department-funds-first-iacs-at-community-colleges-trade-unions/; https://www.newamerica.org/education-policy/edcentral/nsf-funding-fuels-workforce-innovation-at-community-colleges/; https://www.newamerica.org/education-policy/edcentral/edas-stem-talent-challenge-grants-workforce-funding-for-the-innovation-economy/; https://www.newamerica.org/education-policy/edcentral/nsf-epiic-funds-community-colleges-capacitybuilding-and-innovation/; https://www.forbes.com/sites/shalinjyotishi/2025/01/15/work-based-learning-for-emerging-technologie s-and-advanced-industries/;
13 https://www.dol.gov/agencies/eta/skills-training-grants/scc
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Priorities for capacity-building investments include, but are not limited to:
* Modernizing colleges' data infrastructure to better leverage labor market information in studying industries, jobs, and skills that are rapidly changing;
* Procuring industry-standard equipment and teaching tools necessary to deliver high-quality education and training for our advanced and emerging tech sectors;
* Establishing a sustainable and systematic process to upskill instructors, so they can stay current with the frontier skills associated with cutting-edge technologies;
* Strengthening grants infrastructure to better leverage public and private capital and to effectively partner with industry and universities on tech-based economic development initiatives, such as the NSF's Regional Innovation Engines program and the Commerce Department's Regional Technology and Innovation Hubs;
* Scaling work-based learning with employers and industry intermediary organizations to scale registered apprenticeships, youth apprenticeships, internships, micro-internships, and project-based learning in advanced sectors;
* And improving workforce collaboration approaches with research universities, industry, and R&D organizations, including our national laboratories,
ManufacturingUSA Institutes, and other federally funded R&D centers./14
Across red states and blue states, community colleges have always been at the forefront of serving our most low-income students. With strategic and coordinated capacity-building investments, they can help further realize the promise of economic security and the American Dream during this period of rapid technological change.
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14 https://ncses.nsf.gov/resource/master-gov-lists-ffrdc
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Original text here: https://docs.house.gov/meetings/AP/AP07/20260304/119006/HHRG-119-AP07-Wstate-JyotishiS-20260304.pdf
Blackfeet Community College President Hall Testifies Before House Appropriations Subcommittee
WASHINGTON, March 11 -- The House Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies released the following written testimony by Blackfeet Community College President Brad Hall from a March 4, 2026, hearing entitled "Preparing for the Future: America's Community Colleges":* * *
Blackfeet Community College (BFCC), a Tribally controlled, Land-Grant institution in Browning, Montana, provides accessible, high-quality education rooted in Blackfeet culture and values. Accredited by the Northwest Commission on Colleges and Universities, BFCC offers in-person ... Show Full Article WASHINGTON, March 11 -- The House Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies released the following written testimony by Blackfeet Community College President Brad Hall from a March 4, 2026, hearing entitled "Preparing for the Future: America's Community Colleges": * * * Blackfeet Community College (BFCC), a Tribally controlled, Land-Grant institution in Browning, Montana, provides accessible, high-quality education rooted in Blackfeet culture and values. Accredited by the Northwest Commission on Colleges and Universities, BFCC offers in-personand online programs that support academics, workforce development, cultural preservation, and lifelong learning for all students across the Blackfeet Nation and beyond.
When it comes to size and impact, BFCC is small but mighty! For our Fall 2025 semester, we enrolled 362 students, a 14% increase above our Fall 2024 enrollment. We succeed in large part because we offer students a welcoming, supportive environment with a 13:1 student-to-faculty ratio paired with very affordable tuition: just $3,610 for the entire academic year.
BFCC is deeply committed to advancing Tribal and rural prosperity by eliminating the financial, academic, and health and wellness barriers students face. Because 67% of our students receive federal Pell Grants, a core strategy is to provide paid internships and emergency aid to directly alleviate financial hardship and prevent enrollment loss.
Successes: Workforce Development and Career and Technical Education Paired With Industry and Community Partnerships Creates Significant Positive Economic Impacts.
BFCC's key programs that directly lead to employment include the Industry Trades certificate (and planned pathways), which equips students with essential skills for the building trades and directly addresses regional labor gaps; Nursing, which responds to persistent shortages in the health sector; Class 7 Teacher Certification, which prepares local educators to serve in Tribal and rural schools; and programs in Legal Studies and Anthropology, which strengthen Tribal governance and natural resource stewardship. By concentrating on these critical areas, BFCC is effectively laying a robust foundation for strong, self-reliant economic growth in the region.
All of BFCC's programs of study are aligned with the demonstrated needs of our local community, workforce opportunities and cultural revitalization efforts. These combined efforts guide the future development of the college to enhance access to trades, job placement and emerging economic trends of the Blackfeet Nation and our expanding service area, through a strong emphasis on hybrid, land-based and experiential learning.
BFCC has entered into a paid internship agreement with community employers and non-profit organizations. A recent example is with Pursuit, which is providing summer project-based paid internships for BFCC students at the East Glacier Park Lodge, focusing on gardening, engineering, culinary, and hotel management. This partnership will also be instrumental in the college's future development of hospitality and tourism programs that connect students to meaningful career-aligned employment opportunities.
All of these successes for individual students add up to significant financial benefits for the local community, the state economy, and the nation as a whole. In September of 2025, the American Indian Higher Education Consortium (AIHEC) published an economic study highlighting the impact of Tribal Colleges and Universities (TCUs). The study, titled: Building Local Economies of Scale: The Impact of Tribal Colleges & Universities in Rural America, found that in Fiscal Year (FY) 2022-2023, TCU alumni accounted for $3.8 billion in economic impact across the country - the equivalent of supporting 40,732 jobs nationwide. Looking only at BFCC's impact during that same period, the study found that our alumni contributed $15 million to the Blackfeet Indian Reservation economy - the equivalent of supporting 391 jobs. For every $1.00 spent on BFCC, students gain $5.20 in lifetime earnings, U.S. taxpayers gain $1.02 in additional tax revenue and public sector savings, society gains $2.90 in additional income and social savings, and Montana taxpayers gain $3.5 million in additional tax revenue and public sector savings. Not a bad return on investment!
The important role of the Pell Grant Program, Title III, and NACTEP. BFCC's student body is 61% full-time students and 39% part-time students, and 67% of our students receive federal Pell grants. Without the federal Pell grant program, the opportunities we provide would be out of reach for most of our students. We applaud Congress for using the One Big Beautiful Bill Act to appropriate additional funding to the Pell grant program to prevent a near-term shortfall and for creating a new category of Pell grant we are excited to participate in: Workforce Pell. We would also especially like to thank this Subcommittee and your Senate counterparts for keeping the maximum Pell grant award level in place for FY 2026. Going forward, we ask that you appropriate additional funding to shore up the Pell grant program for the long term, while refraining from making any eligibility changes that would limit access. For example, some of the changes proposed this past summer to increase the credit hour eligibility threshold for part-time and full-time students would have been devastating to our students, many of whom are already balancing significant work and family obligations while going to school, and are simply not in a position to take on more credit hours just to qualify for Pell.
The Title III - Strengthening Tribal Colleges and Universities, parts A and F, funds are some of the most flexible and important funds TCUs receive each fiscal year. Title III funds can be used for everything from scientific equipment, to facility construction, to student tutoring, to library books. Because TCUs operate on such limited budgets, largely without any endowments, wealthy alumni networks, or state support to speak of, any interruption, reduction, or delay in these funds would be devastating. If, for some reason, our Title III funds were to disappear, every single TCU would have to close its doors. We would like to thank this Subcommittee and your Senate counterparts for appropriating strong, consistent Title III funding in FY 2026, and we ask that this continue in FY 2027.
While the Native American Career and Technical Education Program (NACTEP) is not specifically for TCUs, we are among the eligible entities, and especially here at BFCC, NACTEP plays an outsized role in our students' success. Our current NACTEP Program supports students enrolled in the following programs of study: AS Hydrology, One Year Certificate in Records Management and AS in Blackfeet Legal Studies. This program provides funding for faculty, comprehensive student support services, and operates a Career Center to support employment readiness upon graduation. We are evolving this program in our new application to provide similar services for our Nursing BSN program, One-year Certificate in Industry Trades and Class 7 Teacher Certification, which develops local educators to become state-certified to teach the Blackfeet Culture and Language as local schools advance language immersion and cultural programs. We would like to thank this Subcommittee and your Senate counterparts for appropriating strong, consistent NACTEP funding in FY 2026, and we ask that this continue in FY 2027.
Challenges
BFCC has operated on the funding that we receive primarily from the Department of the Interior, Department of Education, and the Department of Agriculture as a 1994 Land Grant Institution. Over the last year, our campus has faced significant uncertainty due to shifts in federal funding and administrative policies. Any uncertainty or delay in funding, as witnessed over the last year, directly undermines our college's ability to maintain the consistency of programs and services, ensure employees jobs are protected, and continue to grow our campuses to meet the evolving needs of the "Universal Community" we serve.
All TCU's are open enrollment institutions, any student who wants to, can attend a Tribal College; this is what makes us important drivers of economic, inclusive prosperity to residents in our states and the regions we serve. TCU's remain chronically underfunded, compared to other institutions of higher education in our states and among other Land-Grant Institutions. Our colleges stand as anchors for opportunity in rural and underserved regions where, in many cases, we are the only institution of higher education within hundreds of miles. Continued and increased funding opportunities will enhance what we already do and also fulfill our obligations to our tribal nations, one student success at a time.
Opportunities
BFCC urgently needs a modern facility for our Industry Trades Program to ensure student success and meet regional workforce demand. The new space would include specialized workstations for carpentry, welding, plumbing, and electrical work, along with essential hands-on materials such as lumber, piping, and wiring. This investment will expand the current one-year certificate into stackable two-year pathways, offer additional licenses, and provide practical training that drives local economic growth. By producing qualified, skilled labor to fill critical roles, this facility will reduce reliance on outside contractors, close workforce gaps, and empower graduates to secure well-paying careers, thereby strengthening the region's long-term economic stability and self-sufficiency.
Conclusion
Thank you for including TCUs among the community college witnesses for this important hearing. BFCC remains committed to working collaboratively with the Subcommittee as a trusted resource to ensure that Tribal Nations and Tribal citizens have a say in shaping their education and their future.
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Original text here: https://docs.house.gov/meetings/AP/AP07/20260304/119006/HHRG-119-AP07-Wstate-HallB-20260304.pdf
Bevill State Community College VP Morgan Testifies Before House Appropriations Subcommittee
WASHINGTON, March 11 -- The House Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies released the following testimony by Shawn M. Morgan, vice president of workforce and strategic initiatives at Bevill State Community College, from a March 4, 2026, hearing entitled "Preparing for the Future: America's Community Colleges":* * *
Chairman Aderholt, Ranking Member DeLauro, and distinguished Members of the Subcommittee:
Thank you for the opportunity to provide testimony on the important topic of Preparing for the Future: America's Community Colleges. ... Show Full Article WASHINGTON, March 11 -- The House Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies released the following testimony by Shawn M. Morgan, vice president of workforce and strategic initiatives at Bevill State Community College, from a March 4, 2026, hearing entitled "Preparing for the Future: America's Community Colleges": * * * Chairman Aderholt, Ranking Member DeLauro, and distinguished Members of the Subcommittee: Thank you for the opportunity to provide testimony on the important topic of Preparing for the Future: America's Community Colleges.It is an honor to represent the Alabama Community College System and, specifically, Bevill State Community College, which serves students and communities across Northwest Alabama.
The Alabama Community College System (ACCS) is comprised of 24 community and technical colleges serving more than 160,000 individuals annually. Our mission is both educational and economic. We exist to ensure that every Alabamian--regardless of background or geography-- has access to high-quality education and workforce training aligned with the needs of industry.
Recent economic impact studies show that ACCS institutions contribute over $8 billion annually to Alabama's economy and return measurable public value for every dollar invested. We are not simply institutions of higher learning; we are engines of workforce development and economic mobility.
At Bevill State Community College, that mission is personal. We serve some of the most rural counties in Alabama--across campuses in Jasper, Sumiton, Fayette, Hamilton, and an instructional site in Carrollton. Nearly half of the population in our service region lives in rural communities. For many of our students, we are not just the most affordable option--we are the only accessible option.
And we are delivering results. Our total credit hour production has increased 24% from the 20202021 academic year to the 2024-2025 academic year.
Just one of our highlights, our nursing programs consistently demonstrate excellence, with NCLEX pass rates ranging from 95 to 97 percent in recent years . Over the past three academic years alone, Bevill State has graduated more than 1,000 nurses across our ADN/RN and LPN programs --strengthening healthcare systems throughout rural Alabama at a time when staffing shortages threaten hospital viability.
These outcomes are not accidental. They reflect a model built on industry alignment, local partnerships, and agility.
Proven Models: Industry-Driven, Flexible Pathways
Bevill State operates on a simple principle: workforce programs must be employer-informed and student-centered.
We maintain active advisory committees across healthcare, manufacturing, construction, and transportation. These partnerships allow us to rapidly adjust curriculum, equipment, and delivery models to meet real-time labor market demand.
In our region, manufacturing and skilled trades remain foundational to economic stability.
Nationally, over one million trade jobs remain unfilled, including 500,000 in manufacturing alone . That shortage is felt acutely in rural communities like ours, where retirements outpace replacements and generational knowledge is at risk of being lost.
To address this, Bevill State delivers:
* Short-term, industry-recognized credentials in welding (including SMAW, GMAW, and FCAW processes), industrial maintenance, and construction trades
* Commercial Driver's License (CDL) training to support logistics and supply chain needs
* HVAC Fast Track programs that move students from enrollment to employment in a matter of weeks
* Stackable credentials in healthcare that allow entry-level employment with clear pathways toward advanced licensure
Our approach reduces time-to-competency while preserving academic rigor. Students can enter quickly, earn, and return to continue building credentials over time.
Expanding Opportunities
Dual Enrollment and Early Exposure
The ACCS takes a forward-thinking approach by exposing students to industry-driven college level material at an early age. In the 2024-2025 Academic Year, the system served over 40,000 dual enrollment students who were able to simultaneously attend high school and college-level classes. This number represents an even bigger picture with a 230% increase in enrollment since 2015. At Bevill State, our dual enrollment students have increased over 130% since the 20202021 academic year. While dual enrollment itself is not unique to the ACCS, what makes our programs unique is that we provide low tuition year-round, accessible instructors and resources, lower GPA requirements, and high-quality education opportunities that offer full transferability and academic rigor across all 67 counties in the state of Alabama. Additionally, many of our dual enrollment instructors are local high school teachers credentialed by community colleges, a model that supports K-12 teacher retention and expands instructional capacity statewide.
Through dual enrollment, we are providing opportunities to reach those who may not initially see themselves as college-bound, widening the state's talent pipeline and preparing students for indemand careers.
In rural counties where economic opportunity may appear limited, dual enrollment changes life trajectories.
Workforce Pell Grant - A Transformational Opportunity
The forthcoming Workforce Pell Grant represents one of the most significant federal policy shifts in workforce education in decades. By allowing Pell Grant eligibility for high-quality, short-term programs between 150 and 600 clock hours aligned to high-demand occupations, Congress has the opportunity to remove a major barrier to entry for working adults.
At Bevill State, Workforce Pell would immediately expand access to programs such as CDL, HVAC Fast Track, welding, lineworker training, and healthcare technical certificates. Many of these programs are 8 to 15 weeks in duration--ideal for dislocated workers, underemployed adults, and individuals needing rapid reentry into the workforce.
For rural communities, this is not simply about tuition assistance. It is about economic survival.
Workforce Pell can help stabilize hospitals, support energy infrastructure expansion, and fill critical trade shortages--all while providing liveable, family-sustaining wages.
Alabama Energy Infrastructure Training Center & Network (AEITCN)
In response to growing regional demand for skilled energy and infrastructure workers, Bevill State is leading the development of the Alabama Energy Infrastructure Training Center & Network (AEITCN).
This initiative will include expanded training capacity for:
* Lineworker programs supported by a dedicated pole yard
* Fiber connectivity and broadband infrastructure
* Solar / Microgrid installation and maintenance
* Electric vehicle and battery troubleshooting and maintenance
* HVAC and Weatherization training
The AEITCN will leverage existing campus facilities alongside approximately 50,000 square feet of new training space to create a scalable regional workforce hub. The goal is not merely program expansion--it is the creation of a coordinated, multi-campus network capable of responding quickly to industry growth in utilities, energy production, advanced manufacturing, and infrastructure modernization.
Energy security and workforce development are directly linked. By training local residents for high-skill, high-wage infrastructure careers, we strengthen both regional economies and national resilience.
Skills for Success Program: Our ACCS Innovation Center developed the "Skills for Success" program, which offers customized, rapid-delivery, non-credit, industry-recognized training in high-demand fields like commercial truck driving (CDL), welding, construction, and healthcare.
This program is often offered at no cost to the participant, swiftly moving individuals from unemployment or underemployment into family-sustaining careers.
By reducing the time-to-competency, we accelerate the state's ability to attract new industry jobs. What distinguishes this program is its industry-driven design. Businesses identify their specific workforce needs, and we convene a task force of leaders from across that sector to develop the curriculum. Their combined expertise ensures that our training is precisely aligned with current hiring demands and upskilling priorities.
Supporting Rural Communities and Special Populations
Rural access remains central to our mission. Healthcare shortages threaten the viability of small hospitals across our region. Manufacturing employers struggle to replace retiring skilled technicians. Broadband expansion requires trained fiber technicians. The modernization of energy infrastructure requires certified lineworkers.
Our response is community-specific solutions.
We work directly with hospitals, manufacturers, utilities, and economic development authorities to design targeted pipelines. We provide flexible scheduling, hybrid instruction, and supportive services to adult learners who strive to balance work and family responsibilities.
We also recognize that many untapped workers face barriers--whether financial, academic, or proximity. Community colleges are uniquely positioned to meet individuals where they are in life and help them reach new heights.
Agility as Workforce Strategy
The defining strength of community colleges is agility. When employers ask, "Can you provide the talent?" we must be able to answer "Yes"--not in years, but in months.
At Bevill State, agility means:
* Rapid curriculum development
* Employer-informed equipment investments
* Stackable credential design (short-term, long-term or eventual Associates Degree)
* Flexible delivery models
* Partnerships across K-12, industry, and economic development
Community colleges are the "conduit" between federal investment and local workforce impact.
We translate policy into practical outcomes--jobs filled, wages increased, industries stabilized, and communities strengthened.
America's community colleges are not simply preparing students for the future--we are preparing the future workforce itself.
On behalf of Bevill State Community College and the Alabama Community College System, I thank you for your continued support and for recognizing the essential role community colleges play in America's economic competitiveness.
We stand ready to partner with Congress to ensure that federal workforce investments-- including Workforce Pell--are implemented in ways that maximize opportunity, strengthen rural America, and secure our nation's talent pipeline for generations to come.
Thank you for the opportunity to testify. I look forward to your questions.
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Original text here: https://docs.house.gov/meetings/AP/AP07/20260304/119006/HHRG-119-AP07-Wstate-MorganS-20260304.pdf
U.S. Ambassador to Slovenia Nominee Roberts Testifies Before Senate Foreign Relations Committee
WASHINGTON, March 10 -- The Senate Foreign Relations Committee released the following testimony by Asel Roberts, President Trump's nominee to be U.S. Ambassador to Slovenia, from a March 5, 2026, confirmation hearing:* * *
Chairman Ricketts, Ranking Member Coons, and distinguished Members of this committee:
I am honored to appear before you as President Trump's nominee to be the United States Ambassador to the Republic of Slovenia. I am truly grateful to President Trump and Secretary Rubio for placing their confidence in me to fulfill the important duties and responsibilities of this position.
I ... Show Full Article WASHINGTON, March 10 -- The Senate Foreign Relations Committee released the following testimony by Asel Roberts, President Trump's nominee to be U.S. Ambassador to Slovenia, from a March 5, 2026, confirmation hearing: * * * Chairman Ricketts, Ranking Member Coons, and distinguished Members of this committee: I am honored to appear before you as President Trump's nominee to be the United States Ambassador to the Republic of Slovenia. I am truly grateful to President Trump and Secretary Rubio for placing their confidence in me to fulfill the important duties and responsibilities of this position. Ialso want to thank everybody who has supported me during the last 20 years of my career at the U.S. Department of State, which has led me to this appointment. This includes first and foremost my family. I want to thank my parents for always believing in me, my in-laws for welcoming me into their extended family in Buffalo, NY, my spouse for supporting me every step of the way, and my daughter who has inspired me every day for the last ten years. I also want to thank my colleagues in the Office of the Chief of Protocol who have worked diligently with me to promote U.S. interests through dozens of multilateral and bilateral meetings as well as at summits, state visits, and UN General Assembly Meetings. Without these people, I would not have the opportunity to be before you today.
I was born in the Soviet Union in what is today the Republic of Kazakhstan at a time of great global change. Yet, I was fortunate enough to spend most of my adult life in the United States, something I could never have done if it had not been for President Ronald Reagan and his efforts to end the Cold War. As a high school student at the age of 15, I was able to take advantage of a U.S. government-funded student exchange program and study at high schools in Arizona and Vermont. This prepared me to gain admittance into and complete university in the United States.
I could not have accomplished that journey in any country other than the United States, and it instilled in me a strong belief in the American dream and the critical importance of the U.S. in the world. I have applied this inspiration to my work throughout my career, which has been dedicated to supporting U.S. foreign policy and national interests abroad. Having worked for two decades in the U.S. State Department, my career has uniquely prepared me for the duties for which I have been nominated as the U.S. Ambassador to the Republic of Slovenia.
Through my work in the Office of the Chief of Protocol, I have been involved in organizing hundreds of high-level diplomatic meetings for six different presidential administrations and, as a result, have gained a strong understanding of how to communicate both high-level foreign policy priorities and bilateral concerns with our international counterparts. Additionally, I have worked closely throughout my career with Foreign Service officers and locally employed embassy staff in multiple countries to coordinate high-level visits. Having served for a full year as the Acting Chief of Protocol of the United States, I also have strong experience running a complex and large unit within the State Department, including familiarity with budget management, personnel matters, and leadership. Throughout these experiences, the goal of advancing U.S. interests has always been the motivating force behind my work. I am fully confident in my abilities to fulfill the duties and responsibilities of representing the United States abroad and to effectively manage an embassy.
It would also be a great honor to fulfill these duties in the Republic of Slovenia, which is an important friend and ally to the United States.
Slovenia and the United States share a close relationship rooted in our shared interests, democratic values, economic ties, and our longstanding defense cooperation. Slovenia has made impressive contributions in regional and global efforts to bolster stability and peace. It has proven itself to be a friend of the United States and a reliable NATO ally.
I will work to ensure Slovenia's strong commitment to stability and security remains steadfast.
This includes efforts to meet NATO defense spending and capability commitments. If confirmed, I will work to ensure Slovenia remains a critical part of the deterrence and defense of the Euro-Atlantic region.
Slovenia's strategic location at the crossroads between Central Europe and the Western Balkans also presents opportunities to deepen Transatlantic trade, one of the pillars of the global economy and American prosperity. Slovenia has a small but dynamic economy, with a skilled labor force and some of the best engineers in the world. Despite its small market size, Slovenia has established itself as a hotspot for cutting-edge industries. Its science and tech sectors show particular promise.
There are also critical opportunities to build on our two countries' close cooperation on civilian nuclear energy.
If confirmed, I will prioritize the safety and well-being of U.S. citizens. I will also advocate for American economic security, balanced trade, and fair treatment for U.S. businesses. Additionally, I will continue to push for greater economic cooperation between our countries.
I view this nomination as an opportunity to work diligently to deepen our relationship with Slovenia and to help make America safer, stronger, and more prosperous.
It would be an honor to serve as the U.S. ambassador to the Republic of Slovenia. Thank you for your time and consideration. I look forward to your questions.
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Original text here: https://www.foreign.senate.gov/imo/media/doc/16d85bb1-de33-dd95-fe9f-d71d3fdf66a8/030526_Roberts_Testimony.pdf
U.S. Ambassador to New Zealand Nominee Novelly Testifies Before Senate Foreign Relations Committee
WASHINGTON, March 10 -- The Senate Foreign Relations Committee released the following testimony by Jared Novelly, President Trump's nominee to be U.S. Ambassador to New Zealand, Samoa, the Cook Islands and Niue, from a March 5, 2026, confirmation hearing:* * *
Thank you Chairman Ricketts, Ranking Member Coons, and distinguished Members of this Committee for the opportunity to appear before you today. It is an honor to be nominated as United States Ambassador to New Zealand, the Independent State of Samoa, the Cook Islands, and Niue.
What may be lost on many of us in the private sector is the ... Show Full Article WASHINGTON, March 10 -- The Senate Foreign Relations Committee released the following testimony by Jared Novelly, President Trump's nominee to be U.S. Ambassador to New Zealand, Samoa, the Cook Islands and Niue, from a March 5, 2026, confirmation hearing: * * * Thank you Chairman Ricketts, Ranking Member Coons, and distinguished Members of this Committee for the opportunity to appear before you today. It is an honor to be nominated as United States Ambassador to New Zealand, the Independent State of Samoa, the Cook Islands, and Niue. What may be lost on many of us in the private sector is thelevel of dedication that can be witnessed by those in government. During the lead up to this hearing, I have been exposed to a number of wonderful, bright, and dedicated people in the State Department, and I can honestly tell you that I have been incredibly impressed by the almost selfless determination that I have witnessed.
I wish to express my admiration for all of those who have helped me by thanking them for their service.
So too must I express my admiration for all of the Members of this Committee for your service as well. If confirmed, I hope to, at least, match the dedication to the American people manifested by each of you Members of this committee.
Thank you for your service and I look forward to serving our country with a similar zeal that I have witnessed.
If confirmed as Ambassador, I will work tirelessly to advance President Trump's and Secretary Rubio's foreign policies.
In advancing the President's agenda, we have few better partners than New Zealand. The government of New Zealand consistently supports our goals in the region and beyond.
If confirmed, I will do everything in my power to take our relationship to new heights. Specifically, I intend to focus on three priorities:
1. partnering with New Zealand, Samoa, Cook Islands, and Niue to promote a free and open Pacific;
2. expanding our defense partnership with New Zealand; and
3. promoting opportunities for U.S. business entities.
Few countries understand the darkening security environment in the Pacific better than New Zealand. Last February, China conducted live-fire exercises in the Tasman Sea. I was in the region at the time, and it was very concerning. The exercises led to flight diversions and represented an example of alarming, even destabilizing behavior in the Pacific.
If confirmed, I would prioritize expanding our defense partnership with New Zealand.
I know the critical role our Embassies and Consulates play in ensuring a fair playing field for U.S. entities. Whether it be through tearing down trade barriers or opening new markets, all U.S. businesses will have a friend in the Ambassador's office if I am confirmed.
In Samoa in recent years, the government in Apia has adopted a prudent approach to managing relations with the West and China, taking on foreign debt with caution. If confirmed, I would encourage the government in Samoa to continue this approach and ensure it is never pressured into a deal that would compromise its sovereignty.
In the Cook Islands, establishment of formal diplomatic relations in 2023 enabled us to take our longstanding relationship to the next level. If confirmed, I would expand our collaboration with local authorities to promote the responsible development of seabed mineral resources. The Cook Islands' EEZ contains possibly the largest cobalt deposit in the world - a key component in batteries and high-strength alloys. A strong partnership with the Cook Islands means a strong supply chain of critical minerals. This is good for all parties.
In Niue, I would likewise focus on strengthening our bilateral relationship. We have, and under my watch will continue to, closely engage with Niue on economic, cultural, and other programs. I hope to continue to grow this relationship.
Thank you for considering my nomination. I look forward to your questions.
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Original text here: https://www.foreign.senate.gov/imo/media/doc/16d85bb1-de33-dd95-fe9f-d71d3fdf66a8/030526_Novelly_Testimony.pdf
U.S. Ambassador to El Salvador Nominee Edgar Testifies Before Senate Foreign Relations Committee
WASHINGTON, March 10 -- The Senate Foreign Relations Committee released the following testimony by Troy Edgar, President Trump's nominee to be U.S. Ambassador to El Salvador, from a March 5, 2026, confirmation hearing:* * *
Chairman Ricketts, Ranking Member Coons, and distinguished Members of the Committee, thank you for the opportunity to appear before you today. I am deeply honored by the President's nomination to serve as United States Ambassador to the Republic of El Salvador.
I want to introduce and thank my wife Betty for being here today. I am grateful to my family for their steadfast ... Show Full Article WASHINGTON, March 10 -- The Senate Foreign Relations Committee released the following testimony by Troy Edgar, President Trump's nominee to be U.S. Ambassador to El Salvador, from a March 5, 2026, confirmation hearing: * * * Chairman Ricketts, Ranking Member Coons, and distinguished Members of the Committee, thank you for the opportunity to appear before you today. I am deeply honored by the President's nomination to serve as United States Ambassador to the Republic of El Salvador. I want to introduce and thank my wife Betty for being here today. I am grateful to my family for their steadfastsupport and to the people I have had the privilege to serve alongside throughout my career. Representing the United States abroad is among the highest responsibilities our nation can bestow, and I approach this nomination with humility, seriousness of purpose, and respect for the statutorily mandated role of this Committee.
El Salvador is one of our most important partners in the Western Hemisphere.
Our nations are bound by geography, shared security interests, and enduring ties, including a vibrant Salvadoran American community that strengthens our country every day. The bilateral relationship sits at the intersection of critical U.S. priorities including combatting illegal immigration, counternarcotics and law enforcement cooperation, economic growth, democracy, and regional stability. In many ways, how we work with El Salvador will help shape broader patterns of cooperation and stability across Central America and throughout the Hemisphere.
If confirmed, my mandate will be clear: to faithfully represent the President and the United States, to advance American national security and economic interests, and to strengthen cooperation with the government and people of El Salvador in ways that produce tangible results for both nations.
Effective diplomacy requires resolve and respect in equal measures. If confirmed, I will engage directly with Salvadoran leadership, including President Bukele, to deepen cooperation against transnational criminal organizations and foreign terrorist organizations and expand mutual economic opportunity.
Throughout my career, including as Deputy Secretary of Homeland Security, I have focused on institutional integrity, operational discipline, and supporting the professionals entrusted with executing our nation's policies.
If confirmed, my full attention will be devoted to leading our mission in San Salvador with professionalism, clarity of purpose, and full accountability to this Committee and to the American people.
I welcome your guidance and oversight, and I look forward to your questions.
Thank you.
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U.S. Ambassador to Philippines Nominee Lipton Testifies Before Senate Foreign Relations Committee
WASHINGTON, March 9 -- The Senate Foreign Relations Committee released the following testimony by Lee Lipton, President Trump's nominee to be U.S. Ambassador to the Philippines, from a March 5, 2026, confirmation hearing:* * *
Chairman Ricketts, Ranking Member Coons, and distinguished Members of the Committee, thank you for the opportunity to appear before you today. I am deeply honored to be President Trump's nominee to serve as the next United States Ambassador to the Republic of the Philippines. I appreciate your time and consideration.
I would also like to recognize my wife and soulmate ... Show Full Article WASHINGTON, March 9 -- The Senate Foreign Relations Committee released the following testimony by Lee Lipton, President Trump's nominee to be U.S. Ambassador to the Philippines, from a March 5, 2026, confirmation hearing: * * * Chairman Ricketts, Ranking Member Coons, and distinguished Members of the Committee, thank you for the opportunity to appear before you today. I am deeply honored to be President Trump's nominee to serve as the next United States Ambassador to the Republic of the Philippines. I appreciate your time and consideration. I would also like to recognize my wife and soulmateof more than 45 years, Erika, and our amazing sons, Max and Dylan. Their steadfast love and support have sustained me throughout my career in business and public service. If my parents were alive today, they would be beyond proud to see me sit before you.
Over the course of my 50-year professional career, I have led businesses in the culinary and fashion industries, built international partnerships, created jobs, mentored young professionals, and navigated complex regulatory environments. I look forward to utilizing these skills to the benefit of the American and Filipino people. I developed a lasting respect for the country during my early visits to the Philippines as an entrepreneur, manufacturing clothing decades ago. I was deeply impressed by the Filipino people's energy, resilience, and strong sense of family and community.
Community and people-to-people ties have always mattered to me. The Philippines has a word that captures that spirit -- bayanihan [buy-yaan-nee-haan] -- working together for the common good. With more than 27 billion dollars in bilateral trade in 2025, roughly 375,000 Americans residing in the Philippines, and approximately 5 million Filipinos and Filipino-Americans contributing to communities across the United States, our countries are linked in ways that extend far beyond security cooperation and veterans affairs.
Filipino-Americans are among the largest Asian American groups in the U.S. military, serving across various branches. According to recent estimates, there are around 15,000 active-duty Filipino-American service members in the U.S. Armed Forces. If confirmed, I would work to expand collaboration in the other areas where our interests align -- healthcare, education, semiconductors, critical minerals, energy, infrastructure, humanitarian assistance and disaster response, tourism, and sports diplomacy, just to name a few -- while ensuring that our economic relationship remains fair and reciprocal.
Bringing people together and building coalitions has defined my personal life and my public service. While my career began in the private sector, over the past year, I have had an incredible opportunity in Washington to participate in this administration's humanitarian and diplomatic processes. As a member of the Holocaust Board, I have worked to preserve memories, defend human dignity, and confront hatred. Guided by my faith, I have built partnerships that are grounded in shared principles.
At the State Department, serving at the U.S. Mission to the Organization of American States, I have worked alongside dedicated Foreign Service Officers and civil servants committed to advancing American interests through principled engagement. During my tenure as Interim Permanent Representative and Chief of Staff at the Mission, I saw firsthand the importance of disciplined coordination, interagency collaboration, and accountability in translating policy into results. I also had the opportunity to build working relationships with diplomats from across the Western Hemisphere, reinforcing my belief that strong alliances are sustained through consistent engagement and institutional trust.
In many respects, the Philippines connects regions. Its ties span centuries and reflect the breadth of American engagement and influence across both the Pacific and the Western Hemisphere. Present-day partnerships in commerce, defense, education, entertainment, and cuisine demonstrate how longstanding exchanges have matured into the multifaceted power and cooperation we enjoy today. And as this year's Chair of the Association of Southeast Asian Nations (ASEAN), the Philippines will play an elevated role in promoting our shared interests among the United States and all of Southeast Asia.
If confirmed, I will carry forward that spirit of partnership to Embassy Manila, relying on the expertise of our embassy staff, our colleagues at the Department of War, our allies and partners, ASEAN counterparts, and other representatives from the region who work to support an open, prosperous, and secure Indo-Pacific. My goal will be to deepen U.S.-Philippine security cooperation, strengthen supply chains, advance the Luzon Economic Corridor initiative, and promote fair and transparent trade through close and continuing engagements with this Committee, the U.S. Interagency, and our Philippine Allies.
In closing, I would like to assure you that I approach this nomination with humility and seriousness, and with an unwavering resolve to uphold our ironclad alliance with the Philippines, including our shared commitments under the Mutual Defense Treaty, as well as advance the safety, strength, and prosperity of the United States at a time of great consequence in the Indo-Pacific.
Thank you again for your time and consideration. I look forward to your questions.
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Original text here: https://www.foreign.senate.gov/imo/media/doc/16d85bb1-de33-dd95-fe9f-d71d3fdf66a8/030526_Lipton_Testimony.pdf
Assistant Secretary of State for African Affairs Nominee Garcia Testifies Before Senate Foreign Relations Committee
WASHINGTON, March 9 -- The Senate Foreign Relations Committee released the following testimony by Frank Garcia, President Trump's nominee to be assistant secretary of State for African affairs, from a March 5, 2026, confirmation hearing:* * *
Chairman Ricketts, Ranking Member Coons, and Members of the Committee - I am honored to appear before you today as President Trump's nominee for Assistant Secretary of State for the Bureau of African Affairs. I appreciate the time you and your staff have given me and, if confirmed, I look forward to working with you.
If confirmed, I will advance America ... Show Full Article WASHINGTON, March 9 -- The Senate Foreign Relations Committee released the following testimony by Frank Garcia, President Trump's nominee to be assistant secretary of State for African affairs, from a March 5, 2026, confirmation hearing: * * * Chairman Ricketts, Ranking Member Coons, and Members of the Committee - I am honored to appear before you today as President Trump's nominee for Assistant Secretary of State for the Bureau of African Affairs. I appreciate the time you and your staff have given me and, if confirmed, I look forward to working with you. If confirmed, I will advance AmericaFirst priorities on the African continent and ensure our engagement is disciplined, strategic, and firmly rooted in the protection of core U.S. national interests, as outlined in the National Security Strategy.
On a personal note, I'm thankful my sister Terri is here. I know our brother Michael and our parents are smiling down from heaven. They taught us three lifelong tenets: God, family, and country. As part of the Greatest Generation, they served as a Navy nurse and an Army technical sergeant. They didn't talk about service, they lived it.
I also want to thank my wife, Bridget, and our seven children and eight grandchildren for their love and support. There's a country song, "Thank God for Unanswered Prayers." Today I simply thank God for answered prayers: Bridget and our family are that answer for me. And for anyone wondering how to thrive with seven children and eight grandchildren: zone defense.
I served in the U.S. Navy for 28 years, with many assignments in the AFRICOM area of responsibility. My first touch on the continent was as a junior officer visiting the port of Mombasa, Kenya, which sparked a fascination with Africa that has stayed with me. I currently serve on the House Intelligence Committee for nearly fifteen years of focus Africa, traveling frequently with Members and staff.
Thank you, Team HPSCI, past and present.
My time in Africa left an indelible mark: peace is precious, and it is not maintained by hope alone. That is why I embrace President Trump's National Security Strategy of Peace through Strength. Strength, guided by principle and paired with credible diplomacy, deters aggression, protects the innocent, and creates space for human dignity to flourish. If confirmed, I will bring that same sense of duty to the work ahead.
For too long, U.S. policy in Africa has emphasized aid and dependency, with open-ended commitments and a focus on spreading divisive ideologies. President Trump and Secretary Rubio have reset this relationship toward trade and investment for mutual benefit. Many African partners have welcomed a pragmatic approach that prioritizes opportunity and cooperation over lectures. If confirmed, I will ensure our policy is guided by a realistic calculation of costs, risks, and benefits to U.S. interests.
By 2050, one quarter of the world's population will be African. The continent is at a strategic inflection point where lasting prosperity hinges on a secure, representative government and the selection of reliable partners. A healthy, better educated workforce, paired with abundant natural resources, can create opportunities that benefit both African nations and the United States. The Lobito Corridor model advanced by the Trump Administration is one example, promising increased trade, jobs, and investment. If confirmed, we will build on this momentum by prioritizing U.S. investment in high-return sectors where partnership can help make America safer, stronger, and more prosperous.
With opportunity comes risk, especially when governance fails to provide the security and judicial framework that prosperity requires. President Trump and Secretary Rubio recognize that peace is the foundation of growth and have moved aggressively to support peace efforts in troubled areas across Africa. The Washington Accords for Peace and Prosperity that brought together the Democratic Republic of the Congo and Rwanda, ending more than 30 years of conflict, are historic. The United States will remain steadfast in supporting these accords and in holding the parties to their commitments.
Instability in regions such as the Sahel and North Africa, fueled by illicit trafficking and terrorist expansion, poses direct risks to U.S. interests and citizens.
Our counterterrorism efforts will remain focused on preventing attacks against the homeland and U.S. interests. We will build reciprocal relationships with key partners to degrade transnational threats from ISIS and al-Qaeda affiliates, engage regional governments, and work with allies to promote stability. African nations must play a greater role in protecting their own regions, with the United States supporting local leadership, not substituting for it.
If confirmed, I will ensure every dollar the United States invests in Africa advances our national security and economic priorities. All assistance, including lifesaving health and humanitarian efforts, will be focused, strategic, and aligned with U.S. interests. Our approach will be disciplined and results-driven, applying Secretary Rubio's principle of privileging trade over aid, opportunity over dependency, and investment over assistance.
Members of the Committee, thank you for your consideration and for the time, energy, and focus you and your staff devote to Africa. I look forward to your questions.
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Original text here: https://www.foreign.senate.gov/imo/media/doc/16d85bb1-de33-dd95-fe9f-d71d3fdf66a8/030526_Garcia_Testimony.pdf
House Armed Services Subcommittee Chairman Wittman Issues Opening Remarks at Hearing on Modernization of Organic Industrial Base
WASHINGTON, March 7 -- Rep. Rob Wittman, R-Virginia, chairman of the House Armed Services Subcommittee on Tactical Air and Land Forces, released the following opening remarks from a Feb. 24, 2026, joint hearing with the Subcommittee on Readiness entitled "Modernization of the Organic Industrial Base":* * *
Over the last several years, major vulnerabilities in the organic industrial base (OIB) have become apparent.
After the depletion of stockpiles for support to Ukraine, scaling domestic production, particularly of munitions, has exposed an inability of the supply chain to keep up with the ... Show Full Article WASHINGTON, March 7 -- Rep. Rob Wittman, R-Virginia, chairman of the House Armed Services Subcommittee on Tactical Air and Land Forces, released the following opening remarks from a Feb. 24, 2026, joint hearing with the Subcommittee on Readiness entitled "Modernization of the Organic Industrial Base": * * * Over the last several years, major vulnerabilities in the organic industrial base (OIB) have become apparent. After the depletion of stockpiles for support to Ukraine, scaling domestic production, particularly of munitions, has exposed an inability of the supply chain to keep up with thegrowth in demand.
While modernization efforts have been underway for our arsenals, depots, and ammunition plants, we have a long way to go.
With that said, I have concerns with the sustainability of certain Army goals, specifically the goal to reach production of one hundred thousand 155mm rounds per month.
While I support this goal, as 155's have proven their value in wartime, I worry about the sustainment of production capacity once the demand and requirements for this munition decrease.
It is imperative that the Army responsibly invests in industry partners and production facilities.
I am eager to hear from the witnesses on the progress of the many modernization projects across the OIB.
Most army ammunition plants and arsenals have technology and processes from World War II.
With supplemental dollars and a 15-year modernization strategy with plans to invest roughly $18 billion dollars across the OIB, I'm optimistic about the Army's efforts for updated production technology and facilities.
With improved production lines boasting flexibility and advanced manufacturing, the OIB will be better positioned for production surges.
We must ensure that the billions of dollars we have invested are appropriately spent across facilities.
The modernization of energetics is another key issue within the OIB.
Novel energetics can and will increase lethality and range for ordnance, propulsion, and weapon systems, giving the warfighter a greater edge in future fights and ensuring that our technology remains bounds ahead of our adversaries.
Though industry and academic institutions are currently developing improved energetic materials, the Department is still primarily using the same energetic materials from World War II.
The historic lack of central management and strategy across the services has delayed the progress of novel energetic integration into weapon systems.
I am pleased that since last year's hearing, the Joint Energetic Transition Office has been established.
This office will be key in creating central leadership in advancing energetic innovation and integration.
I am looking forward to seeing the work they'll do across the OIB.
Today's hearing will explore the many challenges the Organic Industrial Base encounters including access to a domestic supply chain, antiquated manufacturing processes and fluctuating requirements.
We will also explore the Army's efforts to scale munition production capacity, to ensure safety standards for servicemembers and civilians working in the production process, and to invest in emerging technologies and new facilities to modernize the OIB.
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Original text here: https://armedservices.house.gov/news/documentsingle.aspx?DocumentID=6403
House Armed Services Subcommittee Chairman Bergman Issues Opening Remarks at Hearing on Modernization of Organic Industrial Base
WASHINGTON, March 7 -- Rep. Jack Bergman, R-Michigan, chairman of the House Armed Services Subcommittee on Readiness, released the following opening remarks from a Feb. 24, 2026, joint hearing with the Subcommittee on Tactical Air and Land Forces entitled "Modernization of the Organic Industrial Base":* * *
The organic industrial base is the heart of our Army's ability to generate combat power, and any inadequacies in the industrial base directly impact the mission-capable rates of our ground forces.
Unfortunately, the Army's readiness trends over the last decade are particularly troubling.
Since ... Show Full Article WASHINGTON, March 7 -- Rep. Jack Bergman, R-Michigan, chairman of the House Armed Services Subcommittee on Readiness, released the following opening remarks from a Feb. 24, 2026, joint hearing with the Subcommittee on Tactical Air and Land Forces entitled "Modernization of the Organic Industrial Base": * * * The organic industrial base is the heart of our Army's ability to generate combat power, and any inadequacies in the industrial base directly impact the mission-capable rates of our ground forces. Unfortunately, the Army's readiness trends over the last decade are particularly troubling. Since2015, almost all Army vehicles experienced declines in mission-capable rates.
Additionally, the Army's maintenance costs are increasing with an average cost increase of over 50%.
According to GAO, the lack of parts and challenges related to technical data negatively affected the availability and costs of the entire ground forces.
These declining mission capability rates and increasing costs are directly related to an underperforming acquisition system.
Our inability to adequately secure the parts and determine the technical data rights at the beginning of our acquisition process undermines the ability of our organic industrial base to adequately maintain our ground vehicle fleet.
Additionally, I think that we are sitting on the precipice of a new dawn where advanced manufacturing revolutionizes our vehicle maintenance approach.
I am not confident that our military is keeping pace with the commercial sector in delivering timely and cost-efficient products.
As to the Army's organic industrial base to generate munitions capacity, our Army arsenals stand at the epicenter.
I think using our arsenal's ability to assemble and build munitions necessary for our combat forces and maintain excess capacity in times of need is a good model to maintain operational readiness.
I also think the organic industrial base needs to be utilized before additional commercial options are pursued.
That is why I am particularly surprised that we continue to sustain foreign munition manufacturers when idled American capacity is available to support munitions production.
We need to be more realistic as to our nation's munition goals and build capacity to meet our needs in times of conflict.
At the same time, it is important that our partners and allies also retain sufficient capacity to support their needs.
It is hard for me to understand why the United States should size our industrial base to meet an apathetic international consortium that has the time but lacks the will to make strategic investments to support their own national security interests.
There is much we need to do to better align our industrial base for the future, and I look forward to working with the administration and our esteemed witnesses to make this a reality.
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Original text here: https://armedservices.house.gov/news/documentsingle.aspx?DocumentID=6404
Google Energy & Sustainability Policy Head Hanna Testifies Before House Science Subcommittee
WASHINGTON, March 7 -- The House Science, Space and Technology Subcommittee on Investigations and Oversight released the following written testimony by Marsden Hanna, head of energy and sustainability policy, government affairs and public policy of the Global Affairs Team at Google, from a Feb. 24, 2026, hearing entitled "Powering America's AI Future: Assessing Policy Options to Increase Data Center Infrastructure":* * *
Chairman McCormick, Ranking Member Sykes and Members of the Subcommittee.
Thank you for the opportunity to speak to you today. My name is Marsden Hanna and I develop Google's ... Show Full Article WASHINGTON, March 7 -- The House Science, Space and Technology Subcommittee on Investigations and Oversight released the following written testimony by Marsden Hanna, head of energy and sustainability policy, government affairs and public policy of the Global Affairs Team at Google, from a Feb. 24, 2026, hearing entitled "Powering America's AI Future: Assessing Policy Options to Increase Data Center Infrastructure": * * * Chairman McCormick, Ranking Member Sykes and Members of the Subcommittee. Thank you for the opportunity to speak to you today. My name is Marsden Hanna and I develop Google'sapproach to energy policies. I appreciate the opportunity to discuss the intersection of artificial intelligence and energy with the Subcommittee. As the United States races to lead the world in AI, permitting and transmission reform has become a critical lever for maintaining our country's competitive edge.
The potential for AI to accelerate U.S. economic growth is staggering. Research estimates that generative AI could result in global economic uplift of more than $4 trillion annually. Realizing these gains - while accelerating breakthroughs in science and fortifying our national security - depends entirely on America's ability to build and power the electrical infrastructure that makes them possible.
Today, we are facing a critical challenge to achieving these goals: fragmented and congested electricity grids across the country are increasingly tapped out and many can no longer support electrical load growth. After decades of flat electricity consumption, recent load growth has resulted in an all-time high demand for power. However, transmission lines, many built more than 50 years ago, are now running out of capacity to power this growth and must be expanded and modernized. The U.S. electric grid needs investment and reinvigoration to simply keep running, let alone grow.
We believe energy supply is a national security imperative. Winning the AI race requires winning the energy race. Currently, the United States is ahead of global competitors on AI development, remaining dominant in developing AI models and designing advanced semiconductors.
However, the gap is closing. The speed with which China can plan, permit and deploy energy infrastructure is a major comparative advantage. China is leveraging this advantage to deploy massive investment into meeting its demand growth, emerging as the largest investor in the global power sector. According to a 2020 report, China has completed over 80 times more high-voltage interregional transmission than the United States in recent years. To maintain our lead in the AI race, we must reverse that trend and at least keep pace with, if not overtake, the rest of the world in development of energy infrastructure.
Today's energy infrastructure permitting system in the United States is a patchwork of local, state, and federal regulations marked by bureaucracy at all levels of government. This leads to crippling timelines, paralyzing litigation, uncertainty and an overall ineffective federal permitting scheme. Critical transmission projects can take up to 10 to 15 years to permit and build. The system is riddled with single points of failure, where litigation over procedural issues can delay or kill projects that are essential for economic growth and reliability - particularly for ambitious energy infrastructure projects that can do the most to advance economic and national security interests. Since passage of the Energy Policy Act of 2005, reliance on its novel federal authorities has resulted in not a single transmission line being built.
U.S. electricity policies and statutory frameworks need urgent reform. We have endorsed the bipartisan SPEED Act (H.R.4776) passed by the U.S. House of Representatives last year. We encourage urgent action to support regional and inter-regional transmission modernization and expansion, including the advancement of robust permitting reform measures this Congress.
Three Pillars of Reform to Spur Innovation
Efforts to build transmission lines in the United States face a full stack of permitting barriers. At the federal level, this includes National Environmental Policy Act (NEPA) processes, which bundle the substantive environmental permitting laws that may trigger reviews across several federal agencies. Further, litigation risks emerge at every touch point and can result in decade-long timeline extensions for routine build outs and upgrades.
Congress can help address these problems and spur American innovation by focusing on three core pillars:
* First, cut energy infrastructure permitting bureaucracy across the board. Reducing permitting timelines to accelerate project schedules can help to reduce project costs and these savings can be passed on to electric ratepayers nationwide.
* Second, establish an effective federal transmission permitting framework.
Congress can speed construction of national interest transmission lines that provide economic and reliability benefits to power growth by reforming federal backstop authority at the Federal Energy Regulatory Commission (FERC).
* Third, Congress should establish clear procedures that provide permitting certainty for new energy projects. Accelerating investment in energy infrastructure requires a consistent and durable permitting framework on which investors, asset owners and purchasers of power can rely to get projects built.
1. Cut Infrastructure Permitting Bureaucracy
America must move faster by cutting infrastructure permitting bureaucracy and eliminating red tape for all electricity infrastructure, including transmission. Congress can begin by legislating a streamlined federal infrastructure permitting process for all upgrades associated with existing infrastructure within existing rights of way, including deployment of advanced transmission technologies.
We also encourage Congress to consider reforms to NEPA and other procedural statutes to speed up the process for critical transmission lines under federal review. Federal legislative reforms can also provide reasonable boundaries on the scope of reviews conducted pursuant to the relevant statute, such as by placing limits on what activities can be considered "major federal actions." In order to provide legal certainty, Congress should also establish: (1) limits on statutes of limitations; (2) clear statutory timelines in which courts must act on permitting litigation and appeals; and (3) reforms that narrow standing to litigate agency actions. We believe that litigation should be limited to stakeholders that have participated in a public comment process and stand to be negatively impacted.
2. Establish an Effective Federal Transmission Permitting Framework
The United States currently has a complex and bureaucratic dual-agency process for Federal transmission permitting, which is layered on top of a permitting gauntlet that runs across some 3,000 utilities, markets, and state, federal and tribal jurisdictions. Federal backstop permitting authority for transmission has been entirely ineffective to date: the process requires the Department of Energy (DOE) to designate a National Interest Electric Transmission Corridor (NIETC), which is a multi-year bureaucratic process combined with a NEPA review. A developer may then apply for permits within a NIETC from states, and if denied the developer can subsequently apply to FERC for a permit. At this stage, FERC conducts a lengthy review process that includes a duplicative NEPA review. Litigation over procedural issues at any stage can halt the process, at which point applicants must start over from the beginning. The current convoluted process simply is not working: over the last 20 years, the NIETC process has led to the construction of zero new transmission lines due to this combination of overly bureaucratic processes and legal uncertainty. Congress can improve and expand the process by which lines become eligible for a federal permit by eliminating the requirements for a DOE NIETC designation and establishing a more effective process to issue permits at FERC for national interest transmission.
We urge Congress to build off of the bipartisan Energy Permitting Reform Act (EPRA) of 2024 by granting FERC permitting authority for backbone interstate transmission lines that mirrors the "certificate of public convenience and necessity" process used for interstate natural gas pipelines. The robust and direct statutory authority that Congress provided FERC to issue permits for interstate natural gas pipelines has been a key factor that has enabled timely gas infrastructure build out. This includes enabling network expansion to accommodate innovative technology advancements such as the advent of unconventional drilling techniques. The U.S. is in another era of innovation-driven growth, but lacks linear infrastructure permitting parity for the transmission grid. This is emerging as an inhibitor - rather than an enabler - of future growth.
Congress should also clarify and expand the scope of eligible transmission lines by providing clear thresholds and criteria for the exercise of federal permitting authority in order to increase the speed at which federal permits can be issued. Eligibility should include transmission lines that are critical for reliability, reducing congestion, reducing costs, increasing carrying capacity, or supporting economic growth. In Google's view, additional circumstances that should trigger FERC permitting authority include:
* Defined and modest expansions of existing transmission rights of way to enable significant voltage upgrades and allow more transmission capacity over the same or similar land;
* To enable longitudinal permitting of transmission alongside existing transportation corridors;
* If a state or local authority denies a permit for a regional transmission project that a region has approved; or
* For lines that are primarily sited within Section 368 corridors designated by the U.S. Bureau of Land Management.
3. Provide Permitting Certainty
Even with an improved, streamlined federal permitting system, large energy projects are still years-long endeavors that require long-term policy and procedural certainty. In order to win the AI race, Congress should establish a durable permitting framework and procedures to modernize America's energy infrastructure on a rapid timeframe. This framework should provide assurance to developers that projects which have satisfied the necessary permitting requirements will be completed without the revocation of authorization.
Expanding our grid is the key to unlocking vast, low-cost energy resources and driving down prices. By strategically building updated, higher voltage backbone transmission lines, the United States can benefit from massive economies of scale. Studies have shown that for every $1 invested in transmission lines, American consumers receive approximately $4 back in benefits. These improvements will reduce system-wide costs, increase reliability and power the next era of economic growth through concentrated energy buildout.
At Google, we believe in the promise of AI and we are investing heavily in the infrastructure behind it across the U.S. - many of you have seen that in your states. In just the last six months of 2025, we announced investments of $40 billion in Texas, $9 billion each in South Carolina, Oklahoma, and Virginia, $7 billion in Iowa and $4 billion in Arkansas, with more investments to come. Realizing the potential of artificial intelligence will require robust energy infrastructure, more efficient energy use and new, innovative technology solutions. I look forward to today's discussion and to working with many more of you on these investments. They are a reflection of the opportunity we see in America.
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Original text here: https://republicans-science.house.gov/_cache/files/c/d/cd6fa0e5-4adf-41dd-b6f0-8d9f412a711f/7F809390EF5E02C52D46B9D1BF09E0D7EE78A0A03584E44A8B5C79FB9728E031.marsden-hanna-testimony.pdf
EveryLife Foundation for Rare Disease Mission Officer Kennedy Testifies Before Senate Special Committee on Aging
WASHINGTON, March 7 -- The Senate Special Committee on Aging released the following written testimony by Annie Kennedy, chief mission officer for the EveryLife Foundation for Rare Diseases, from a Feb. 26, 2026, hearing entitled "From Regulator to Roadblock: How FDA Bureaucracy Stifles Innovation." FDA is the Food and Drug Administration.* * *
Thank you, Chairman Scott, Ranking Member Gillibrand, and distinguished members of the Committee, for convening this critical hearing to explore how the Food and Drug Administration can enhance regulatory clarity and predictability - and foster a more ... Show Full Article WASHINGTON, March 7 -- The Senate Special Committee on Aging released the following written testimony by Annie Kennedy, chief mission officer for the EveryLife Foundation for Rare Diseases, from a Feb. 26, 2026, hearing entitled "From Regulator to Roadblock: How FDA Bureaucracy Stifles Innovation." FDA is the Food and Drug Administration. * * * Thank you, Chairman Scott, Ranking Member Gillibrand, and distinguished members of the Committee, for convening this critical hearing to explore how the Food and Drug Administration can enhance regulatory clarity and predictability - and foster a morepatient-centered, efficient review process for rare disease therapies. These changes, if made, will strengthen U.S. biomedical leadership and ensure lifesaving therapies reach our rare disease patient community as soon as possible.
My name is Annie Kennedy, and I serve as the Chief Mission Officer for the EveryLife Foundation for Rare Diseases. I am especially honored to be here today on behalf of the more than 800 rare disease advocates who have joined us in Washington for Rare Disease Week on Capitol Hill. Our families have traveled great distances and from most every state - including each state represented on this committee - to be here this week - and we each proudly represent the more than 30 million Americans living with rare diseases./i
The Orphan Drug Act defines a rare disease as a condition that affects fewer than 200,000 people in the United States. Today, there are more than 10,000 distinct rare diseases,/ii about 70 percent of which start in childhood./iii
Some of these are more common, such as Cystic Fibrosis and Duchenne muscular dystrophy. Others are so rare that they are considered N of 1 and are named by their genetic mutation. Collectively, our rare community comprises more than 10% of the U.S. population.
Congressional Efforts Yielded a Movement That Reshaped Methodology in Rare Disease
A stable and predictable regulatory environment is critical to the rare disease therapy development ecosystem. Over the past decade, our rare disease community has seen hundreds of life-altering and life-saving therapies become reality, and we appreciate that each and every day, researchers and drug developers are working to develop therapies for the 95 percent of the community that is still waiting for their first approved therapy.
For patient communities comprised of small numbers whose diagnoses typically occur after long, heartbreaking, and expensive diagnostic odysseys during which the disease has progressed - and function has declined - time is a precious commodity.
Randomized, double blind, placebo-controlled trials that are traditionally conducted in conditions with larger, well characterized, and slowly progressing disease populations are neither appropriate, nor ethical, when considering the challenges and urgency of rare disease.
Congress has long recognized that statutory "regulatory flexibility" is a means to accelerate treatments for patients living with rare diseases. Over the last two decades, your leadership has provided therapy developers and regulators tools that have not only rocketed the United States into renown as the most competitive developer of rare disease products - but most importantly, have yielded life-changing medicine approvals for thousands of children and adults within our rare disease community.
More than 40 years ago, Congress enacted the landmark Orphan Drug Act (ODA) to create a designation, incentives and other processes to help evolve what to that point had been a largely neglected sector, devoid of approved products. Since that time, Congress has further recognized the complexities and challenges associated with rare disease therapy development - and has unleashed a decade-plus of innovation through the establishment of scientific, clinical, and regulatory infrastructure intended to create an environment of rapid and tailored development.
Through the 21 st Century Cures Act, multiple FDA user fee cycles, the recent reauthorization of the Rare Disease Pediatric Priority Review Voucher program, and other actions, we have seen the advent of life saving therapy development incentives, the patient focused drug development movement, the establishment of the FDA Rare Disease Innovation Hub, and application of the accelerated approval pathway to rare disease - all while ensuring that the highest standards of safety and efficacy were upheld.
The application of the accelerated approval pathway to rare disease therapy development called for access to emerging therapies that have achieved safety and efficacy based on the earliest signals of promise, when considered against known alternative disease outcomes. And while over 250 therapies have been approved using the accelerated approval pathway, only 20%/iv of these have been for rare non-oncological diseases.
As a result of Congress' leadership, rare disease patient advocacy organizations have witnessed improved engagement and understanding of the patient perspective through various approaches, including the Patient-Focused Drug Development workshops, the development of the FDA Benefit-Risk Framework, the formation of rare disease-focused initiatives within CDER and CBER, as well as reporting on the use of patient experience data within the regulatory review process.
Also transforming community engagement and sponsor development, legislation has spurred FDA's issuance of numerous guidance documents that are informing the conduct of patient-focused product development activities for drugs, cell- and gene-based therapies, diagnostics, and medical devices that has been critical to our pipelines.
In fact, nearly 1,400 orphan-designated therapies are changing the lives of patients and families./v
These past Congressional efforts yielded a movement that reshaped methodology.
And while this movement and the critical application of methodology have yielded benefit for some, we have only just begun. Still, the vast majority of our communities living with the more than 10,000 rare diseases still have no FDA approved treatments. To date, fewer than five percent of rare diseases have an FDA approved treatment - and none have been cured.
In other words, the majority of our nation's rare disease community are living with rapidly progressive and debilitating conditions for which there is no treatment. This is the challenge before us today. Unfortunately, despite four decades of positive scientific momentum, progress has stalled.
Momentum Has Shifted
We are here today because our community has experienced worrisome trends with devastating consequences.
While we have been incredibly heartened by announcements flagging support of rare disease therapy development initiatives such as the Rare Disease Evidence Principles (RDEP) framework and the Plausible Mechanism Pathway, our community has experienced a series of FDA actions on rare disease product applications that seem misaligned with recent public pledges to expand the use of regulatory flexibility in evaluating rare disease therapies.
* Since the start of 2025, at least 23 Complete Response Letters (CRLs) declining to approve rare disease therapies have been issued - many of which were being considered under the accelerated approval pathway.
* Several of the recent CRLs include comments that indicate a hesitation to apply regulatory flexibility on issues such as the use of surrogate endpoints, natural history studies, external controls, and real-world evidence.
* Previously, novel product reviews encountering complex discernment might initiate the convening of a product - or topic - specific advisory committee for the inclusion of insights of external experts to inform decision making.
* Yet in 2025, the FDA held 65% fewer advisory committee meetings for prescription drugs, biologics, and related topics than in 2024,/vi sharply reducing opportunities for external expertise and patient insights to inform FDA decisions. In some cases, meetings that were expected to discuss rare disease products - that later received a negative regulatory decision - were cancelled.
Congressional Action to Ensure Today's Patients Will Benefit from Robust Rare Disease Treatment Pipelines
In order to ensure that this generation of patients living with rare diseases benefit from the innovation within our nation's robust therapy pipelines, we ask that Congress conduct oversight of the following:
* The application of the accelerated approval pathway to rare disease therapies;
* Resolving the inconsistent and unpredictable application of regulatory flexibility; and
* Resuming the use of Advisory Committee Meetings to receive external expertise on product reviews and key policy topics.
We also ask that Congress provide the necessary resources and direction to optimize the Rare Disease Innovation Hub's ability to improve outcomes for rare disease patients through enhanced coordination and alignment between medical product centers.
Finally, within the remit of the Rare Disease Innovation Hub, we urge FDA to establish a Rare Disease and Condition Advisory Committee to ensure the Agency can leverage external expertise and patient insights in its approach to rare disease regulatory reviews. While not a product-review committee, this would provide a clear mechanism for FDA to obtain the necessary perspective from rare disease stakeholders to inform this work.
Closing
While the FDA has taken actions to implement rare disease related provisions of the user fee bills and created new rare disease infrastructure through the Rare Disease Innovation Hub, the impact of these and other actions has not yet been fully realized for the benefit of the rare disease community.
The uneven application of rare disease policies and recent actions across the agency are resulting in increased unpredictability and risk that we fear could slow or prevent promising therapies from reaching those who need them most.
At a time when advances in science and understanding of diseases have put life-alerting treatments within reach for many communities, the uneven application of regulatory tools created by Congress is threatening our rare disease patient community's future.
Time is the most precious commodity for rare disease community.
And when a promising therapeutic target faces delays or demise due to the complexities in rare disease and strain on the existing regulatory infrastructure, investment wanes, future scientific promise is unfulfilled, and lives are lost.
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About the EveryLife Foundation for Rare Diseases:
The EveryLife Foundation for Rare Diseases is a 501(c)(3) nonprofit, nonpartisan organization powered by the rare disease community to improve health outcomes by driving change through evidence-based policy, leading science-driven policy and regulatory research, activating the community to advocate for their rights and needs, and strengthening the rare disease community.
Contact:
Jamie Sullivan
Senior Vice President of Policy & Advocacy
EveryLife Foundation for Rare Diseases
JSullivan@everylifefoundation.org
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Footnotes:
i National Institutes of Health- National Center for Advancing Translational Sciences. (n.d.). Genetic and rare diseases information center. Genetic and Rare Diseases Information Center. https://rarediseases.info.nih.gov/
ii National Institutes of Health- National Center for Advancing Translational Sciences. (n.d.). Genetic and rare diseases information center. Genetic and Rare Diseases Information Center. https://rarediseases.info.nih.gov/
iii Nguengang Wakap S, Lambert DM, Olry A, Rodwell C, Gueydan C, Lanneau V, et al. Estimating cumulative point prevalence of rare diseases: analysis of the Orphanet database. Eur J Hum Genet. 2020;28(2):165-73.
iv Expediting treatments in the 21st century: orphan drugs and accelerated approvals | Orphanet Journal of Rare Diseases | Springer Nature Link
v Food and Drug Administration: Office of Orphan Products Development. (n.d.)Orphan Drug Product Designation Database. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm
vi https://insights.citeline.com/pink-sheet/product-reviews/us-advisory-committees/us-fda-sees-advisory-committee-volume-collapse-in-2025T265ZITIFREIRBHA7PFGREWACM/
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Original text here: https://www.aging.senate.gov/imo/media/doc/70d7fe5b-cf94-be74-1bd6-5af9e596a188/Testimony_Kennedy%2002.26.26.pdf
Competitive Enterprise Institute Center for Energy & Environment Research Fellow Lambermont Testifies Before House Science Subcommittee
WASHINGTON, March 7 -- The House Science, Space and Technology Subcommittee on Investigations and Oversight released the following written testimony by Paige Lambermont, research fellow of the Competitive Enterprise Institute Center for Energy and Environment, from a Feb. 24, 2026, hearing entitled "Powering America's AI Future: Assessing Policy Options to Increase Data Center Infrastructure":* * *
Chairman McCormick, Ranking Member Sykes, and distinguished members of the subcommittee, thank you for holding this hearing today and inviting me to testify.
My name is Paige Lambermont and I am ... Show Full Article WASHINGTON, March 7 -- The House Science, Space and Technology Subcommittee on Investigations and Oversight released the following written testimony by Paige Lambermont, research fellow of the Competitive Enterprise Institute Center for Energy and Environment, from a Feb. 24, 2026, hearing entitled "Powering America's AI Future: Assessing Policy Options to Increase Data Center Infrastructure": * * * Chairman McCormick, Ranking Member Sykes, and distinguished members of the subcommittee, thank you for holding this hearing today and inviting me to testify. My name is Paige Lambermont and I ama Research Fellow in the Center for Energy and Environment at the Competitive Enterprise Institute, a nonprofit, non-partisan public policy organization dedicated to free market, limited government principles with a focus on regulatory issues.
I am grateful for the opportunity to speak to you today about the importance of permitting changes and innovation to meet rising power demand.
I have three main points that I want to make in my testimony:
1. Power scarcity has been created by policy decisions
2. Permitting reform is essential to meet this challenge
3. Now is the time for new and innovative solutions
Power Scarcity is a Policy Decision
For the last several decades, energy policy in general, and electricity policy in particular has focused on making do with less, curtailing demand, producing less power, and electrifying things like cars and appliances.
These policies have simultaneously created less reliable electricity, while also using government intervention to increase reliance on electricity. This was never a plan that was going to foster reliability, but now that demand has begun to rise for the first time in nearly two decades, the true folly of that approach has been revealed.
According to a DOE report, 104 GW of firm power capacity are set to retire by 2030./1
At the same time, demand growth by 2030 is projected to be between 35 and 108 GW./2
The delta between retiring capacity and new demand will require new reliable capacity to fill the gap.
Ideally, the permitting and policy ecosystem would favor the swift construction of new reliable power plants and the supply chains for building these plants would still be intact. In this hypothetical world new power demand from data centers would be an opportunity to generate electricity to solve complex problems and generate economic productivity.
But, on our broken power grid, where it is incredibly difficult to build new power plants, and the supply chain to build those power plants has broken down, this opportunity becomes a challenge.
The priority should be the formulation of policy that turns that challenge back into an opportunity.
We are more than capable of meeting growing power demand, but this will require removing regulatory barriers that impair the construction of new power plants and the reliability of the power grid. There are many policy changes that will contribute to this, but two of the most important actions will be comprehensive broad-based and technology neutral permitting reform, and removing obstacles to innovation.
Permitting Reform is Essential to Meet This Challenge
To help solve the current power supply issue, our federal permitting system must be reformed in ways that go beyond the National Environmental Policy Acy (NEPA). The Clean Water Act (CWA), Clean Air Act (CAA), Endangered Species Act (ESA), and other laws must be amended in parallel to remove overbroad, duplicative, and unnecessary requirements to secure permits.
This would help create a federal permitting process that allows new development to occur in a timely, predictable, and cost-effective manner while maintaining high standards.
Regulatory agencies also play a role in making it more difficult to build new power plants. So while the Environmental Protection Agency (EPA) is a primary culprit, another agency that's been especially restrictive is the Nuclear Regulatory Commission (NRC). The ADVANCE Act helped to bring the mission of the NRC in line with the goal of stewarding rather than simply overseeing the nuclear industry./3
But improvement must go much further if nuclear power is going to play a role in meeting rising demand.
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1 U.S. Department of Energy, "Resource Adequacy Report: Evaluating the Reliability and Security of the United States Electric Grid," July 2025, https://www.energy.gov/sites/default/files/202507/DOE%20Final%20EO%20Report%20%28FINAL%20JULY%207%29_0.pdf.
2 U.S. Department of Energy, "Resource Adequacy Report: Evaluating the Reliability and Security of the United States Electric Grid," July 2025, https://www.energy.gov/sites/default/files/202507/DOE%20Final%20EO%20Report%20%28FINAL%20JULY%207%29_0.pdf.
3 Congress.gov. "S.870 - 118th Congress (2023-2024): An act to authorize appropriations for the United States Fire Administration and firefighter assistance grant programs, to advance the benefits of nuclear energy, and for other purposes." July 9, 2024. https://www.congress.gov/bill/118th-congress/senate-bill/870.
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In China, the current timeline for a large reactor from start to finish is seven years and there are currently 27 reactors under construction./4
The last large reactors built in the US were Plant Vogtle Units 3 and 4 which took 14 and 15 years respectively and began construction in 2009./5
The United States is not losing on quality of technology, or ability to innovate in this space. It's losing on regulation, and that is entirely a policy choice. Ensuring that the regulatory structures that govern the development of new power plants of all types are reasonable, predictable, consistent, and scientifically based is essential to develop new power plants at the necessary speed to meet rising demand and remain globally competitive.
Now is the Time for New and Innovative Solutions
Another option to ease the bottleneck around getting new power on the grid is to enable innovation including off-grid utilities. Consumer Regulated Electricity (CRE) is an opportunity to create an alternative to the traditional grid pathway for new customers that are willing to pay for their own electricity. CRE would allow for privately financed, off-grid electric utilities to serve customers including data centers. These utilities would be physically islanded from the broader power grid./6
This would allow companies who want power quickly to avoid the traditional utilities queue, while bearing the costs of their own infrastructure.
CRE provides flexibility and speed to companies working on innovative projects, while providing cost insulation for ratepayers. For this to be possible, individual states would need to pass legislation exempting islanded utilities from their definition of a public utility. This policy innovation has already become law in New Hampshire and related legislation has been introduced in several other states. At the Federal level, the DATA Act, S.3585, introduced by Senator Tom Cotton (R-AR) would enable CRE by clarifying that CRE utilities are exempt from federal regulation as public utilities.
Conclusion
To meet growing demand and protect ratepayers, it is essential that we both reform our permitting system and remove government obstacles to allow new and innovative solutions. It is technologically possible to meet rising demand, and we can and should do so in a way that protects existing ratepayers while allowing for new development.
Thank you.
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4 Stephen Ezell, "How Innovative is China in Nuclear Power", Information Technology & Innovation Foundation, June 17, 2024, https://itif.org/publications/2024/06/17/how-innovative-is-china-in-nuclearpower/.
5 Energy Information Administration, "Plant Vogtle Unit 4 begins commercial operation," May 1, 2024, https://www.eia.gov/todayinenergy/detail.php?id=61963.
6 https://www.cato.org/briefing-paper/case-consumer-regulated-electricity-private-electricity-grids-offerparallel-path#federal-reforms-support-cre
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Original text here: https://republicans-science.house.gov/_cache/files/e/8/e8af86fd-f7cb-4af4-b7e9-fcb3b00e3610/EE8C250912EF0D47B2E329E726F0AA627B4B2B3FD31FF6834017A8946ED482D8.paige-lambermont-testimony-for-2.24.pdf
Amicus Therapeutics President Campbell Testifies Before Senate Special Committee on Aging
WASHINGTON, March 7 -- The Senate Special Committee on Aging released the following written testimony by Bradley Campbell, president and CEO of Amicus Therapeutics Inc., Princeton, New Jersey, and a board member of the Biotechnology Innovation Organization, from a Feb. 26, 2026, hearing entitled "From Regulator to Roadblock: How FDA Bureaucracy Stifles Innovation." FDA is the Food and Drug Administration.* * *
Chairman Scott, Ranking Member Gillibrand, and distinguished committee members:
My name is Bradley Campbell, and for the last 20 years, I've worked at Amicus Therapeutics, a Princeton, ... Show Full Article WASHINGTON, March 7 -- The Senate Special Committee on Aging released the following written testimony by Bradley Campbell, president and CEO of Amicus Therapeutics Inc., Princeton, New Jersey, and a board member of the Biotechnology Innovation Organization, from a Feb. 26, 2026, hearing entitled "From Regulator to Roadblock: How FDA Bureaucracy Stifles Innovation." FDA is the Food and Drug Administration. * * * Chairman Scott, Ranking Member Gillibrand, and distinguished committee members: My name is Bradley Campbell, and for the last 20 years, I've worked at Amicus Therapeutics, a Princeton,New Jersey-headquartered company whose mission is to develop and deliver transformative medicines for people living with rare diseases. Since August 2022, I have had the honor and privilege of serving as President and CEO.
I am also a member of the Board of Directors of the Biotechnology Innovation Organization (BIO), the Advisory Board of the Duke Margolis Institute for Health Policy, and the Corporate Advisory Board for the National Tay-Sachs and Allied Diseases Association.
As I speak with you today, I would note that Amicus is in the process of being acquired by BioMarin Pharmaceuticals, but my remarks today are based on my thirty years of experience in drug development, and in particular the twenty years I have spent at Amicus.
Amicus has successfully developed and commercialized three products that treat two lifethreatening lysosomal storage disorders. These rare genetic disorders are caused by the body's inability to break down substances it normally would, leading to progressive, often irreversible, and potentially fatal organ and muscle damage.
These medicines are a small molecule drug chaperone for Fabry disease (Galafold), and a twocomponent therapy for Pompe disease that combines an oral small molecule enzyme stabilizer (Opfolda) with an infused biologic enzyme replacement therapy (Pombiliti).
I am grateful to Chairman Scott, Ranking Member Gillibrand, and the distinguished members of the Senate Special Committee on Aging for the opportunity to speak today about Amicus' experience developing medicines for serious and life-threatening rare diseases since our founding in 2002.
I am proud to speak today alongside my fellow panelists Cara O'Neill, rare disease mom and Chief Science Officer at the Cure Sanfilippo Foundation, Annie Kennedy, Chief Mission Officer at the EveryLife Foundation, and Dr. Jeremy Schmahmann, Professor of Neurology at Harvard Medical School.
I would like to thank the many members of the rare disease community who are in the room with us today, and in the Capitol this week, in celebration of Rare Disease Day, and to build on the powerful legacy of the Orphan Drug Act (ODA), passed by Congress in 1983.
Similar to the ODA, the reauthorization of the FDA's Pediatric Priority Review Voucher program on February 3 is another example of how bipartisan Congressional action, informed by rare disease advocates, can help drive meaningful advances in rare disease research and drug development. It is critical that we protect and strengthen existing incentives for orphan drug development while we address other regulatory and policy issues.
On behalf of all of us at Amicus, I want to thank the many patients and families in the U.S. and around the world who have made our work at Amicus possible, and to share how their insights have made our work better.
For example, at a recent patient advisory group meeting, we were speaking with Pompe patients about "patient experience data," and how to make it more quantitative, which, in turn also makes these data more measurable-- very salient to today's discussion of regulatory frameworks.
During a break between sessions, a young woman came up to me and said that while clinical trials in Pompe disease often measure "forced vital capacity," she depends on a mechanical ventilator to breathe. Therefore, she said, what would truly make a difference in her life was if she could just hold her breath for one minute. Why? Because if her ventilator battery fails, or she falls, or if an aide has to clear a mucus plug from her trachea tube, those 60 seconds could mean the difference between life and death.
That led all of us to reflect on how many breaths we take each day, and how easily we take for granted that the next one will always follow the last.
Her comment remains one of the most profound and simple examples of why it is critical to listen to the voice of patients and caregivers in designing clinical trials and regulatory endpoints that reflect what truly matters to the rare disease community.
The core message of my testimony today is straightforward and builds on this insight: the rare disease innovation ecosystem, as currently regulated, and which historically has done so much in supporting the development of new therapies for people living with rare diseases, must adapt in speed, flexibility, and scale to meet the magnitude of unmet medical need facing American patients.
We cannot ask patients to wait years for new treatments when the difference between life and death can be a single breath.
Working Together to Get Treatments to Rare Disease Patients Faster
To understand why this is true, I would like to share more about Amicus, both our successes and setbacks.
Since our founding in 2002, Amicus has grown from a small start-up into a global organization of more than five hundred team members supporting three approved medicines and the patients who rely on them.
But our success was never a given, and definitely not a straight line.
When we were developing an oral chaperone treatment for Fabry disease (Galafold), we initially planned for it to be used by all adult patients with Fabry. However, our early trials showed that migalastat worked well for some patients, but not others. Through deeper analysis of trial data and in close dialogue with regulators, Amicus developed and validated an assay that
could identify which out of the thousands of known genetic variants were responsive to treatment --and just as importantly, which were not.
The FDA ultimately incorporated this concept of "amenability" directly into the drug's labeling. The result was Galafold became the first oral precision therapy for Fabry disease, matched to patients most likely to benefit.
This is a concrete example of regulators and sponsors learning together, rather than treating trials as one-shot, binary verdicts. The result is a more convenient oral treatment option that frees a subset of Fabry disease patients from the hours-long burden of bi-weekly infusions and relieves the health care system from the added costs that come from hospital and clinicbased infusions.
The lesson is consistent: innovation is not just about creating new medicines in the lab. It requires working collaboratively with regulators, patient advocates, researchers, and more to build regulatory pathways that are flexible and designed to adapt as they learn -- providing patients and clinicians with novel treatment options as well as more data about how to apply those options to optimize health outcomes for people living with rare diseases.
But as with so many other biotechs, not every Amicus research program developing a novel medicine has crossed the proverbial finish line of FDA approval.
In epidermolysis bullosa (EB), a devastating skin disease, we launched what was at the time the largest ever trial for EB, but promising early data were contradicted in a Phase 3 trial that showed some efficacy but failed to beat placebo on the primary endpoints.
Rather than shelving the data in our archives, we communicated everything we learned with the EB community, including investigators, patient leaders, regulators, and even other companies working in the EB space.
We did this fully and deliberately, so others could build on what we had learned rather than spend scarce resources and precious patient time on ground we had already covered.
Since then, the FDA has approved the first topical gene therapy for dystrophic EB and the first cellbased gene therapy specifically for recessive dystrophic EB-- proof that responsible data sharing can help move the whole rare disease community forward.
So, for Amicus, after more than 20 years in drug development, while we now have three approved drugs, we have had many more programs that were discontinued.
Rare diseases are incredibly complex and inherently more difficult to study than more common, better understood diseases. That is one reason why the vast majority of biotech companies fail, and even when they succeed, the time to get to consistent profitability and sustainability is measured in decades, not years. Amicus was founded in 2002 and became profitable only at the end of last year.
Research supported by the U.S. National Institutes of Health (NIH) estimates 95 percent of the 10,000-plus known rare diseases still lack effective, FDA-approved treatments. That means roughly 9,500 rare diseases lack treatment today.
If we keep the current pace of innovation, averaging 31 orphan-designated novel approvals per year across CDER and CBER over the last five years,/i then developing treatments for half of all known rare diseases (~5,000 conditions) would take approximately 161 years.
We know that America's small and mid-size biotechs are the engine for new medicines overall, and for rare diseases in particular./ii
I firmly believe that these companies will be better able to create new medicines, faster, if we adopt more flexible, agile regulatory frameworks and fully harness new tools including artificial intelligence. These approaches should also be harmonized between the U.S. FDA and other advanced regulatory agencies to minimize the collection of data that does not meaningfully advance our understanding of patient safety or product efficacy.
The FDA has reached much the same diagnosis. The creation of the Rare Disease Innovation Hub (RDIH), Rare Disease Evidence Principles (RDEP), and many other FDA programs all acknowledge that conventional drug development paradigms and evidence standards simply do not work for many rare and ultra-rare conditions.
These are all welcome efforts, but we need to transition from meetings and pilots to agency infrastructure to train staff on how to consistently implement novel approaches and best practices, convene external expert working groups to resolve scientific and regulatory bottlenecks, and de-risk promising new biomarkers.
I believe there are three fundamental areas where we need to concentrate our efforts to modernize regulations and make rapid progress without sacrificing patient safety or public health.
A. Start Clinical Trials Faster--Without Lowering Safety Standards
Other country regulators have adopted or are building faster pathways that allow early-phase trials to activate in weeks rather than months. In January 2026, the European Union launched FAST-EU (Facilitating and Accelerating Strategic Clinical Trials) to cap the time to authorization of multinational clinical trials at 70 days./iii
Under Australia's Clinical Trial Notification (CTN) system, many trials can begin almost immediately after local ethics approval./iv
What these models have in common is that they are shifting early clinical learning, investment, and trial leadership away from the United States. U.S. reforms should:
* Reduce administrative burdens on trial sites and sponsors by standardizing documents and processes, including clinical trial contracts, informed consent, and modular e-consent.
* Enable integration of new artificial intelligence tools to analyze complex datasets and for predictive enrollment, adaptive randomization, and site ID.
* Support single Institutional Review Boards (sIRBs), and leverage cloud services to centralize document collection and enable real-time data quality monitoring.
* Expand the use of decentralized and hybrid trials, master protocols and platform studies, RWE and external controls for decision making and remote monitoring.
* Provide Congress with routine reports on rare disease trial transformation that reflect key success metrics.
B. Use Biomarkers and Innovative Endpoints to Assess When Medicines are Working
Policymakers should support and expand FDA's capability to convene stakeholders and design fit-for-purpose biomarkers and endpoints, as well as building internal knowledge management systems that enable reviewers to apply those tools consistently and predictably.
This starts with
* Sufficiently funding and staffing the Rare Disease Innovation Hub to convene more public, multistakeholder efforts that prioritize, develop, and operationalize a growing set of reusable endpoints (including composite endpoints) and biomarkers across rare diseases.
* Investing in systematic reviewer training and support so sponsors know that innovative and flexible approaches will be utilized consistently across divisions and centers.
* Harmonizing FDA and EMA expectations for high quality real-world evidence (RWE)-- especially in rare pediatric populations--so it can support decisions and, where appropriate, labeling quality.
* Finalize and expand Platform Technology Designation (PTD) to enable carryover of validated assays, analytics, and chemistry and manufacturing control (CMC) elements across platform modalities (including gene therapy and gene editing), with transparent crosscenter criteria and routine reporting on PTD.
C. Make Inspections and Manufacturing Rules Work Better for Rare Disease Medicines
For rare and low-volume therapies, manufacturing and inspection can become rate-limiting steps to patient access. To keep pace with innovation and the unique challenges with rare disease low volume products, FDA should:
* Expand the use of Mutual Recognition Agreements (MRAs) with other advanced regulatory agencies and expand the use of Remote Regulatory Assessments (RRAs) to reduce duplicative in-person inspections.
* Streamline foreign facility inspections by using Artificial Intelligence to prioritize risk-based inspections. This would conserve FDA inspection resources for high risk/high priority inspections and share burdens more equitably with other trusted regulatory agencies.
In addition, Congress should pass the Biomanufacturing Excellence Act of 2025 (H.R. 6089 and S. 3188) which directs the National Institute of Standards and Technology (NIST) to establish a National Biomanufacturing Center of Excellence (COE) to advance manufacturing methods to ensure innovative products can move rapidly from clinical to commercial scale.
Conclusion
Let me leave you with one final story. At an Amicus Patient Advisory Board meeting last year, one of our Fabry patient advisors said that he had stopped saving for retirement when he was first diagnosed in his late thirties. What he found online about Fabry disease at the time, was that life expectancy for men with Fabry disease was only into their late fifties.
But advances in treatment for Fabry disease, including earlier diagnosis, and better management of disease complications are extending lives and changing expectations.
That gentleman is now saving for retirement. For him, for the woman with Pompe disease who told us she needed 60 seconds to breathe, for the many patients we have learned from, and even more, around the world--we need to have a regulatory framework that can accelerate bringing these patients new treatments.
Please join me in helping to make a future to look forward to the reality for many more adults, children, and families living with rare diseases, including the advocates standing in this room today.
Thank you, and I look forward to answering your questions.
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Footnotes:
i This does not include supplemental New Drug Applications, or supplemental Biological License Applications (sNDA or sBLA). Drugs with Orphan designations are exempt from the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c) requirements... It also does not include label indications for drugs that are were originally approved for non-orphan indications. While the total number of available treatments for rare diseases is higher, we believe that counting Orphan Designated approvals is the best way to measure the rate of innovation in rare disease drug development.
ii Biotechnology Innovation Organization. America's Innovation Engine: The Power of Small and Mid-Sized Biotechs. https://www.bio.org/sites/default/files/2026-01/the_power_of_small_and_mid-size_biotechs.pdf
iii https://www.aifa.gov.it/en/fast-eu
iv Steyn N, Davis S. Australia: The Regulatory and Reimbursement Environment. Third in a three-part series. Parexel; August 28, 2023. Available at: https://www.parexel.com/application/files/resources/assets/Australia%20Regulatory%20Market%20Acces s %20Article_Third%20in%20a%20three-part%20series%20(1).pdf (accessed Feb. 18, 2026)
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Original text here: https://www.aging.senate.gov/imo/media/doc/70d7fe5b-cf94-be74-1bd6-5af9e596a188/Testimony_Campbell%2002.26.26.pdf
