National Biotechnology Initiative Act of 2025
Introduced in both the House and the Senate in April 2025, the National Biotechnology Initiative Act of 2025 (H.R. 2756 / S. 1387) aims to streamline regulations inhibiting biotechnology innovation and strengthen U.S. competitiveness in biotechnology. If passed, the legislation would establish a National Biotechnology Coordination Office within the Executive Office of the President to lead a whole-of-government strategy for advancing biotechnology and promoting innovation. The newly created office would be tasked with, for example, easing regulatory burdens on well-understood products and coordinating across agencies to improve the climate for biotechnological innovation. A bipartisan group of lawmakers introduced the bill, which has been referred to various committees in both houses of Congress.
PBM Reform Act
Congress is considering legislation to reform the role of pharmacy benefit managers (PBMs) within the healthcare system. In July 2025, a bipartisan group of legislators introduced the PBM Reform Act (H.R. 4317). The bill proposes a number of different changes. For example, the bill would ban “spread pricing,” require transparency in reimbursements, rebate flows, and pricing, and alter the compensation structure for PBMs.
Pediatric Priority Review Voucher (PRV) Program Renewal
Developing treatments for rare conditions, especially those faced by children, is particularly challenging for manufacturers. Manufacturers seeking to develop innovative drugs in this space face high research and development costs, small patient populations, and unique scientific hurdles associated with treating children. In recognition of these challenges, Congress created the Pediatric Priority Review Voucher (PRV) Program in 2012, which offers financial incentives to encourage drug development for rare pediatric diseases. When a manufacturer received approval of a drug treating a rare pediatric condition, the PRV program granted manufacturers a voucher for a priority FDA review of another drug, a valuable incentive for manufacturers facing a lengthy FDA approval process. These vouchers could be sold to other companies, which allowed companies another opportunity to recoup the massive investments made in developing a treatment for a rare pediatric condition.
The PRV program expired in 2024, and Congress has not yet reauthorized the program. However, a new bill, the Give Kids a Chance Act of 2025 (H.R. 1262 / S. 932), is pending in both the House and the Senate. If passed, the bill would extend the PRV program until 2029. It has bipartisan support from lawmakers and is widely supported by patient groups and pharmaceutical companies as an essential tool to encourage investment in therapies for underserved pediatric populations and rare conditions.
Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization
In 2006, the Pandemic and All-Hazards Preparedness Act (PAHPA) authorizes a suite of programs within the Department of Health and Human Services to improve public health emergency preparedness and response. PAHPA supports advanced research and manufacturing capabilities for pandemic preparedness, including funding for vaccine and therapeutic development. It also creates governmental infrastructure intended to manage the response to pandemics, biothreats, and infectious diseases.
PAHPA expired in 2023, but Congress temporarily extended several provisions through September 2025. PAHPA’s future remains uncertain. The Trump Administration has proposed changes to PAHPA-authorized programs, including reorganizing certain programs and eliminating others.
Ensuring Pathways to Innovative Cures (EPIC) Act
The bipartisan EPIC Act (H.R. 1492 / S. 832) seeks to address one of the unintended consequences of the Inflation Reduction Act’s drug-pricing provisions—the so-called “pill penalty.” This Inflation Reduction Act provision subjects small-molecule drugs to government price controls four years earlier than biologic products. This disincentivizes research and investment in small-molecule drugs. The pill penalty has been widely criticized. For example, President Trump issued an Executive Order decrying the pill penalty as “distort[ing] innovation by pushing investment towards expensive biological products.”
The EPIC Act, if passed, would eliminate the pill penalty by harmonizing timelines between prescription drugs and biologics, which would ensure balanced incentives across drug categories.
National Security Commission on Emerging Biotechnology Recommendations
Congress tasked the National Security Commission on Emerging Biotechnology with examining and issuing a report about how advancements in emerging biotechnology and related technologies will shape current and future national security priorities and needs. Earlier this year, the Commission released a report describing its findings and making a number of recommendations. It identified four main areas of action for the federal government: (1) “promote U.S. biotechnology innovation,” (2) “be the biotechnology partner of choice for the world,” (3) “use national security tools to protect [the U.S.] innovation and industrial base in biotechnology,” and (4) “work with the international community, including China where prudent, to develop best practices and standards for biosafety and biosecurity to prevent against misuse, whether deliberate or accidental.” Based on those priorities, the Commission identified 49 specific recommendations, including a recommendation that Congress establish a National Biotechnology Coordination Office to facilitate interagency biotechnology regulation and policy, and a recommendation that the Department of Defense work more closely with private companies to develop and manufacturer critical biotechnology products.
Since the release of the report, several bills have been introduced seeking to implement the Commission’s recommendations. For instance, the National Biotechnology Initiative Act (H.R. 2756 / S. 1387) adopts the Commission’s recommendations to create a National Biotechnology Coordination Office and seeks to streamline federal biotechnology regulations. These legislative proposals remain pending.
National Security Biotechnology Workforce Training Act
Introduced in October 2025, the National Security Biotechnology Workforce Training Act (H.R. 5770) is currently pending in the House. If passed, it would fund training programs and apprenticeships to address critical workforce shortages in biomanufacturing and biotechnology. The Secretary of Defense is tasked with implementing the training program. By investing in talent development, the bill seeks to ensure that the U.S. innovation ecosystem has the skilled professionals needed to scale production of advanced therapies and maintain global competitiveness.