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CSBA Letter to Congressional Leaders on PBM, PPRV, and SBIR

Council for State Biotechnology Associations (CSBA) • Letters, Testimony & Comments • 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 ProgramExtend the SBIR/STTR ProgramsAdvance important PBM transparency reformsReauthorize the Rare Pediatric Disease Priority Review Voucher ProgramWe 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…

Press Release • December 5, 2025

WASHINGTON, D.C. – Phyllis Arthur, Executive Vice President and Head of Health Policy and Programs of the Biotechnology Innovation Organization (BIO) released the following statement on the December 2025 ACIP meeting.“For decades, the CDC’s Advisory Committee on Immunization Practices (ACIP) has been a shining example of America’s leadership in scientific excellence and evidence-based decision-making.This year we’ve seen this once-transparent, apolitical process led by clinicians and infectious disease experts eroded meeting by meeting. Adopting recommendations without rigorous analysis leaves American children and families vulnerable to deadly infectious diseases that have long been preventable because of vaccines. It sows confusion among patients and providers and undermines access.Today’s decision to change the recommendation for hepatitis B vaccination for newborns, despite 35 years of progress toward eliminating the disease in children, will result in increased rates of hepatitis B, causing liver disease and cancer.BIO urges ACIP to reaffirm its long-standing, transparent, balanced, evidence-based processes that support timely vaccine access and safeguard the nation’s ability to prevent deadly infectious diseases.”###About the Biotechnology Innovation Organization (BIO)BIO is the premier biotechnology advocacy organization representing biotech companies, industry leaders, and state biotech associations in the United States and more than 35 countries around the globe. BIO members range from biotech start-ups to some of the world’s largest biopharmaceutical companies – all united by the same goal: to develop medical and scientific breakthroughs that prevent and fight disease, restore health, and improve patients’ lives. BIO also organizes the BIO International Convention and a series of annual conferences that drive partnerships, investment, and progress within the sector. Learn more at bio.org.

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Letters, Testimony & Comments • December 4, 2025

Re: Docket No. CDC-2025-0783; Advisory Committee on Immunization Practices (ACIP) MeetingDear Dr. Zadeh and Members of the ACIP:The Biotechnology Innovation Organization (BIO) appreciates the opportunity to provide comments to the Advisory Committee on Immunization Practices (ACIP) in advance of the December 4-5, 2025 meeting. BIO encourages the reinstatement of several long-standing practices that have historically supported ACIP’s application of high-caliber science and transparent evidence-based decision making to safeguard Americans’ ability to protect against deadly infectious disease and avoid unintended disruptions to vaccine supply and patient access.BIO is the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 35 other nations. BIO membership includes vaccine developers and manufacturers who have worked closely with the public health community to support policies that help ensure access to innovation and life-saving vaccines for all individuals.For decades, the U.S. has been a global leader in scientific rigor and health innovation in vaccines, exemplified by policy developed through a transparent and predictable process. The Committee’s recommendations have earned trust because they have been consistently informed by structured evaluations that used the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system and the Evidence to Recommendation (EtR) processes. Continuous consistency and predictability in vaccine guidance from ACIP allows the U.S. to accelerate the delivery of vaccines to those wanting and needing them and to support the ongoing development of new vaccines.The longstanding ACIP process provides a model of integrity and transparency. Its success lies in structured reviews of the full body of evidence related to a vaccine conducted over multiple public meetings supported by…

Press Release • December 2, 2025

WASHINGTON, D.C. – John F. Crowley, President and CEO of the Biotechnology Innovation Organization (BIO) released the following statement on reports of the retirement of Richard Pazdur from the US FDA.“Dr. Pazdur has dedicated decades of his career to public service and the needs of patients. He exemplifies the type of expert and steady leadership that has made the United States the home to the world’s leading medical breakthroughs. Dr. Pazdur’s departure raises serious concerns about the repeated turnover in key leadership occurring at the FDA. We need organizational strength and stability at the Agency. This constant turmoil is undermining America's leadership in biotechnology, creating unprecedented regulatory instability and unpredictability, and risks ceding this critical sector to China. As BIO has long upheld - it is imperative that we retain and recruit scientific expertise and strong leadership of the highest caliber at our health agencies and that the standards that are the hallmark of these health institutions are upheld and advanced. We are at a tipping point. It is time to right this ship.”###About the Biotechnology Innovation Organization (BIO)BIO is the premier biotechnology advocacy organization representing biotech companies, industry leaders, and state biotech associations in the United States and more than 35 countries around the globe. BIO members range from biotech start-ups to some of the world’s largest biopharmaceutical companies – all united by the same goal: to develop medical and scientific breakthroughs that prevent and fight disease, restore health, and improve patients’ lives. BIO also organizes the BIO International Convention and a series of annual conferences that drive partnerships, investment, and progress within the sector. Learn more at bio.org.

Press Release • December 2, 2025

WASHINGTON, DC (December 2, 2025) – The Biotechnology Innovation Organization (BIO), in partnership with the Council of State Bioscience Associations (CSBA), released today its latest biennial report on best practices in bioscience economic development initiatives: The U.S. Bioscience Industry: A Powerful Engine for State Economies.The report details the diverse strategies states, cities, and municipalities are using to strengthen the bioscience ecosystem in their communities and support America's global leadership in biotechnology."This report underscores how deeply biotechnology is woven into our nation's fabric and serves as a roadmap for how states can help maintain America’s global biotechnology leadership," said John F. Crowley, President and CEO of BIO. "It shows how smart investments in biomanufacturing, research, and workforce development don't just bring effective medicines to patients, they also foster economic vitality across the country."The report examines public policy initiatives across all 50 states and Puerto Rico, highlights standout programs, and identifies national trends, including:R&D Incentives: Thirty-nine states and Puerto Rico now offer research and development tax credits, many refundable, to help early-stage bioscience companies access capital. Thirty-two states and Puerto Rico support SBIR/STTR matching grants for companies in their regions. In the coming decade, the bioscience market is expected to expand rapidly -- with forecasts predicting it will reach over $5 trillion by 2034.Jobs & Investment Boosts: States are expanding job creation and capital investment grants to attract and retain bioscience employers that inject our economy with good-paying jobs. In the U.S. alone, the bioscience industry's total economic impact (as measured by overall output) exceeded $3.2 trillion in 2023, supporting a large number of direct and indirect jobs.Manufacturing Tax Relief: Forty states and Puerto Rico are offering sales and use tax…