CSBA Letter to Congressional Leaders on PBM, PPRV, and SBIR
December 8, 2025
Dear Congressional Leaders:
On behalf of the Council of State Bioscience Associations (CSBA)—a national coalition of independent, state and territory-based organizations representing the full breadth of America’s biotechnology ecosystem—we write to urge swift congressional action on three bipartisan, urgently needed policies that will strengthen the U.S. life sciences sector and improve patient access to affordable, life-changing therapies.
According to a recent industry report, U.S. bioscience industry employment in 2023 reached 2.3 million jobs in more than 149,000 businesses across every state in the U.S. and Puerto Rico. The total economic impact of the bioscience industry on the U.S. economy, as measured by overall output, totaled $3.2 trillion dollars in 20231. Our member companies—many of them research-intensive, pre-revenue biotechnology innovators—are working every day to discover treatments and cures for diseases that currently have none. Their ability to continue taking scientific and financial risks depends heavily on clear, stable federal policy frameworks. Just as importantly, patients across the country depend on policymakers to ensure the affordability, accessibility, and timely development of new therapies.
Congress has a critical opportunity to advance reforms that directly help patients and promote the virtuous circle of biotech innovation. To support the ecosystem, we urge you to:
Reauthorize the Rare Pediatric Disease Priority Review Voucher Program
Extend the SBIR/STTR Programs
Advance important PBM transparency reforms
Reauthorize the Rare Pediatric Disease Priority Review Voucher Program We strongly urge passage of the “Mikaela Naylon Give Kids A Chance Act” to ensure continuity of the FDA Rare Pediatric Disease Priority Review Voucher (RPD PRV) program. Nearly half of rare disease patients are children, yet therapeutic options remain extremely limited due to high development costs and small patient populations. The RPD PRV program has been one of the federal government’s most effective tools for incentivizing the development of new pediatric rare disease therapies.
Since 2012, FDA has awarded 53 vouchers covering 39 rare pediatric diseases—36 of which previously had no approved treatments. These innovations have benefitted more than 200,000 vulnerable children. The program has enjoyed bipartisan support and has been successfully reauthorized twice. The successful PRV program, one that small biotech companies have incorporated into their financing strategies, and come to rely on since its inception, lapsed in December 2024. Without reauthorization, progress in drug development for children with rare diseases will slow and hope will diminish for families facing life-threatening rare conditions. We urge Congress to prevent any further interruption of this critical program. Extend the SBIR/STTR Programs to Protect U.S. Innovation and Competitiveness We also urge immediate action to extend the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs which expired on September 30, 2025.
For more than four decades, SBIR and STTR have served as the largest and most reliable early-stage capital sources for R&D-intensive startups—particularly biotechnology companies working on high-risk, high-reward therapeutic innovations. Even a short lapse would have severe consequences for the nation’s innovation capacity, undermining small business job creation, disrupting research pipelines, and delaying biomedical advances.
State governments recognize the high value of these programs: more than 28 states operate SBIR matching-grant initiatives that leverage federal funding and accelerate commercialization. Stability and continuation of SBIR/STTR are essential for maintaining U.S. leadership in biotechnology and ensuring that federal agencies and small businesses can plan effectively. Congress must extend the program immediately which will provide time to finalize a comprehensive reauthorization while protecting America’s most productive early-stage innovation engine.
Advance PBM Transparency and Accountability Reforms As Congress continues its work to improve health care access and affordability, we urge passage of comprehensive Pharmacy Benefit Manager (PBM) reforms. These reforms—agreed to by both chambers and nearly enacted last year—are overdue and urgently needed.
Three PBMs currently process almost 80% of prescription drug claims in the United States, creating a marketplace in which opaque contracting practices, spread pricing, rebate structures, and formulary design can drive up costs for patients and employers while limiting choice. For the tens of millions of Americans managing chronic or acute medical conditions, these practices translate into delays, denials, and unaffordable out-of-pocket costs—even when employers already cover the majority of health care expenses.
The bipartisan package would take meaningful first steps toward restoring fairness and transparency by:
Requiring full transparency into PBM practices, incentives, and financial arrangements;
Banning spread pricing;
Requiring 100% pass-through of rebates, fees, and discounts to plan sponsors and patients; and
De-linking PBM compensation from drug prices.
These reforms would reduce perverse incentives, promote true market competition, and improve affordability for families nationwide. Congress came close to enacting these provisions last year; we urge you to finish that work now.
Across the country, biotechnology companies—large and small—are working to deliver the next generation of therapies, cures, and life-sustaining technologies. To succeed, they require federal policies that promote affordability, transparency, stability, and innovation. We urge Congress to swiftly pass these critical programs and deliver important reforms for patients and future biomedical innovation.
Thank you for your leadership and your continued commitment to advancing policies that support patients, strengthen American innovation, and maintain the United States’ role as the global leader in biotechnology.
Sincerely,
AR - BIOArkansas AZ - Arizona Bioindustry Association, Inc. (AZBio) CA - Biocom California CA - California Life Sciences CA - SoCalBio CO - Colorado BioScience Association CT - BioCT FL - BioFlorida GA - Georgia Life Sciences IA - Iowa Biotechnology Association ID - Idaho Technology Council IL - Illinois Biotechnology Innovation Organization, iBIO IN - Indiana Life Sciences Association KS - AdAstra Bio KY - Kentucky Life Sciences Council LA - Louisiana Bio MA - MassBio MD - Maryland Tech Council MI - Michigan Biosciences Industry Association (MichBio) MO - Missouri Biotechnology Association MT - Montana Bioscience Alliance NC - NCLifeSci ND - Bioscience Association of North Dakota NE - Bio Nebraska NH – New Hampshire Life Sciences NJ - BioNJ NM - New Mexico Biotechnology & Biomedical Association NV - Nevada Biotechnology & Health Science (NevBio) NY - NewYorkBIO OH - The Ohio Life Sciences Association OK - Life Science Oklahoma OR - Oregon Life Sciences PA - Life Sciences PA PR - INDUNIV Research Center, Inc./ BIO Puerto Rico RI - RI Bio SC - SCbio SD - South Dakota Biotech TN - Life Science TN TX - Texas Healthcare & Bioscience Institute TX - Texas Healthcare and Bioscience Institute UT - BioUtah VA - Virginia Biotechnology Association WI - BioForward Wisconsin WV - Bioscience Association of West Virginia
Dear Majority Leader Thune, Minority Leader Schumer, Speaker Johnson, and Minority Leader Jeffries:The Council of State Bioscience Associations (CSBA) is a coalition of independent state and territory based non-profit trade associations, each of…
Dear Congressional Leaders:
On behalf of the Council of State Bioscience Associations (CSBA)—a national coalition of independent, state and territory-based organizations representing the full breadth of America’s biotechnology ecosystem—we write to urge swift congressional action on three bipartisan, urgently needed policies that will strengthen the U.S. life sciences sector and improve patient access to affordable, life-changing therapies.
According to a recent industry report, U.S. bioscience industry employment in 2023 reached 2.3 million jobs in more than 149,000 businesses across every state in the U.S. and Puerto Rico. The total economic impact of the bioscience industry on the U.S. economy, as measured by overall output, totaled $3.2 trillion dollars in 20231. Our member companies—many of them research-intensive, pre-revenue biotechnology innovators—are working every day to discover treatments and cures for diseases that currently have none. Their ability to continue taking scientific and financial risks depends heavily on clear, stable federal policy frameworks. Just as importantly, patients across the country depend on policymakers to ensure the affordability, accessibility, and timely development of new therapies.
Congress has a critical opportunity to advance reforms that directly help patients and promote the virtuous circle of biotech innovation. To support the ecosystem, we urge you to:
Reauthorize the Rare Pediatric Disease Priority Review Voucher Program
We strongly urge passage of the “Mikaela Naylon Give Kids A Chance Act” to ensure continuity of the FDA Rare Pediatric Disease Priority Review Voucher (RPD PRV) program. Nearly half of rare disease patients are children, yet therapeutic options remain extremely limited due to high development costs and small patient populations. The RPD PRV program has been one of the federal government’s most effective tools for incentivizing the development of new pediatric rare disease therapies.
Since 2012, FDA has awarded 53 vouchers covering 39 rare pediatric diseases—36 of which previously had no approved treatments. These innovations have benefitted more than 200,000 vulnerable children. The program has enjoyed bipartisan support and has been successfully reauthorized twice. The successful PRV program, one that small biotech companies have incorporated into their financing strategies, and come to rely on since its inception, lapsed in December 2024. Without reauthorization, progress in drug development for children with rare diseases will slow and hope will diminish for families facing life-threatening rare conditions. We urge Congress to prevent any further interruption of this critical program.
Extend the SBIR/STTR Programs to Protect U.S. Innovation and Competitiveness We also urge immediate action to extend the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs which expired on September 30, 2025.
For more than four decades, SBIR and STTR have served as the largest and most reliable early-stage capital sources for R&D-intensive startups—particularly biotechnology companies working on high-risk, high-reward therapeutic innovations. Even a short lapse would have severe consequences for the nation’s innovation capacity, undermining small business job creation, disrupting research pipelines, and delaying biomedical advances.
State governments recognize the high value of these programs: more than 28 states operate SBIR matching-grant initiatives that leverage federal funding and accelerate commercialization. Stability and continuation of SBIR/STTR are essential for maintaining U.S. leadership in biotechnology and ensuring that federal agencies and small businesses can plan effectively. Congress must extend the program immediately which will provide time to finalize a comprehensive reauthorization while protecting America’s most productive early-stage innovation engine.
Advance PBM Transparency and Accountability Reforms
As Congress continues its work to improve health care access and affordability, we urge passage of comprehensive Pharmacy Benefit Manager (PBM) reforms. These reforms—agreed to by both chambers and nearly enacted last year—are overdue and urgently needed.
Three PBMs currently process almost 80% of prescription drug claims in the United States, creating a marketplace in which opaque contracting practices, spread pricing, rebate structures, and formulary design can drive up costs for patients and employers while limiting choice. For the tens of millions of Americans managing chronic or acute medical conditions, these practices translate into delays, denials, and unaffordable out-of-pocket costs—even when employers already cover the majority of health care expenses.
The bipartisan package would take meaningful first steps toward restoring fairness and transparency by:
These reforms would reduce perverse incentives, promote true market competition, and improve affordability for families nationwide. Congress came close to enacting these provisions last year; we urge you to finish that work now.
Across the country, biotechnology companies—large and small—are working to deliver the next generation of therapies, cures, and life-sustaining technologies. To succeed, they require federal policies that promote affordability, transparency, stability, and innovation. We urge Congress to swiftly pass these critical programs and deliver important reforms for patients and future biomedical innovation.
Thank you for your leadership and your continued commitment to advancing policies that support patients, strengthen American innovation, and maintain the United States’ role as the global leader in biotechnology.
Sincerely,
AR - BIOArkansas
AZ - Arizona Bioindustry Association, Inc. (AZBio) CA - Biocom California
CA - California Life Sciences CA - SoCalBio
CO - Colorado BioScience Association CT - BioCT
FL - BioFlorida
GA - Georgia Life Sciences
IA - Iowa Biotechnology Association ID - Idaho Technology Council
IL - Illinois Biotechnology Innovation Organization, iBIO IN - Indiana Life Sciences Association
KS - AdAstra Bio
KY - Kentucky Life Sciences Council LA - Louisiana Bio
MA - MassBio
MD - Maryland Tech Council
MI - Michigan Biosciences Industry Association (MichBio)
MO - Missouri Biotechnology Association MT - Montana Bioscience Alliance
NC - NCLifeSci
ND - Bioscience Association of North Dakota NE - Bio Nebraska
NH – New Hampshire Life Sciences NJ - BioNJ
NM - New Mexico Biotechnology & Biomedical Association NV - Nevada Biotechnology & Health Science (NevBio) NY - NewYorkBIO
OH - The Ohio Life Sciences Association OK - Life Science Oklahoma
OR - Oregon Life Sciences PA - Life Sciences PA
PR - INDUNIV Research Center, Inc./ BIO Puerto Rico RI - RI Bio
SC - SCbio
SD - South Dakota Biotech TN - Life Science TN
TX - Texas Healthcare & Bioscience Institute TX - Texas Healthcare and Bioscience Institute UT - BioUtah
VA - Virginia Biotechnology Association WI - BioForward Wisconsin
WV - Bioscience Association of West Virginia