PAHPA a national security priority

A national security priority: BIO pushes PAHPA reauthorization in 2026

BIO joined over 80 organizations and companies in signing a letter to Congress urging reauthorization of the Pandemic and All Hazards Preparedness Act (PAHPA) before year’s end—a top BIO priority.

Why it matters: PAHPA protects national security by preparing America for public health emergencies. Routinely reauthorized for five-year periods, PAHPA has been existing on short-term funding extensions since 2023.

Government-industry collaboration supported by PAHPA includes federal purchase of medical countermeasures (MCMs) against chemical, biological, radiological, and nuclear threats, pandemic influenza, and emerging infectious diseases. MCMs are held in the Strategic National Stockpile (SNS).

BIO’s priorities for PAHPA legislation:

• Reauthorization of several Administration for Strategic Preparedness and Response (ASPR) programs, including the Biomedical Advanced Research and Development Authority (BARDA), the SNS, Project BioShield, and the Pandemic Influenza Program.
• Reauthorization of the Medical Countermeasure Priority Review Voucher (MCM PRV) program, incentivizing development of MCMs.
• Authorization of a Pathogen-Agnostic Viral Family program at BARDA to enable efficient research into treatments addressing multiple viruses.

BIO’s view: “This is a national security priority, an important way to protect Americans,” explains Phyllis Arthur, BIO's EVP and Chief of Global Health. “We are at a time when Americans care a great deal about what's happening in terms of our nation being ready for known and unknown threats.”

Read more on Bio.News.

BIO recommends competitiveness agenda in House hearing

BIO submitted written recommendations to the Sept. 16 House Science, Space, and Technology Subcommittee on Investigations & Oversight hearing on “Balancing Biotechnology Innovation and Biosecurity: Securing U.S. Leadership.”

BIO recommends: “A comprehensive competitiveness agenda that strengthens every stage of the biotechnology ecosystem, from basic research and early-stage development to manufacturing and commercialization. This agenda should prioritize seven areas:”

1. Accelerating early-stage drug development: Modernize the Investigational New Drug (IND) process. Optimize Phase 1 clinical trials regulation. Establish a coordinated national clinical trial strategy. Maintain skilled regulators.
2. Expanding manufacturing capacity: Encourage domestic biomanufacturing with financial tools like tax incentives. Support advanced manufacturing technology and moving foreign manufacturing to America.
3. Strengthening supply chains and infrastructure: Establish a National Strategic Biomanufacturing Priority List identifying strategic inputs. Incentivize domestic input production.
4. Developing the biotechnology workforce: Coordinate a national framework for biomanufacturing education. Support students and training programs.
5. Improving access to capital: Strengthen R&D incentives. Focus on needs of small- and medium-sized biotechs. Share federal scientific infrastructure and regulatory expertise. Encourage public-private partnerships and private investment.
6. Protecting intellectual property: Further clarify patent eligibility. Provide reliable enforcement. Limit abusive challenges. Enhance international protection of trade secrets.
7. Ensuring sustained federal coordination and research support: Establish a federal coordinating body to develop a national biotechnology strategy. Maintain predictable, merit-based, federal funding.

Highlights of the hearing:

• The Biosecurity Modernization and Innovation Act, legislation in which BIO is engaged that would require gene synthesis screening to secure potentially dangerous nucleic acid sequences, was promoted by one witness.
• Concerns about China were cited by Reps. Zoe Lofgren (D-CA) and April McClain Delaney (D-MD) who highlighted the National Security Commission on Emerging Biotechnology report, which BIO has praised.

What Else to Read

Bill would make Rare Pediatric Disease Priority Review Voucher (PPRV) program permanent. Legislation to permanently authorize the U.S. Food and Drug Administration’s (FDA) PPRV program, was introduced Sept. 14 by Reps. Gus Bilirakis (R-FL), Nanette Barragán (D-CA), Kat Cammack (R-FL), Jake Auchincloss (D-MA), Tom Kean, Jr. (R-NJ) and Kevin Mullin (D-CA). Reauthorized every five years and scheduled to sunset in 2029, the program incentivizes development of rare pediatric disease treatments. “The Rare Pediatric Disease PRV program provides critical incentives for rare disease research and development at no cost to taxpayers," BIO President & CEO John F. Crowley commented. "Permanent reauthorization of this vital program would bring hope to children and families touched by rare disease who have no more time to wait, and stability and confidence for biotech innovators who are leading the way in the discovery of breakthrough treatments.” Read more here.

FDA approves Ultragenyx treatment for Sanfilippo syndrome Type A. Ultragenyx Pharmaceutical on Sept. 17 announced Food and Drug Administration (FDA) approval of FAYUVI™ for the treatment of pediatric patients with mucopolysaccharidosis type IIIA, also known as Sanfilippo syndrome Type A. “FAYUVI™ is the first-ever FDA-approved treatment for Sanfilippo syndrome Type A, a progressive and fatal neurodegenerative disease, and the second gene therapy approval for Ultragenyx. The Company received a Priority Review Voucher upon this approval,” Ultragenyx said. Read more here.

Fourth measles death is most in a year since 1992. Pennsylvania health officials last week reported the state’s fourth measles death this year, the first time four people died of measles in the U.S. since 1992, CNN reports. Officials say lax vaccination rates have caused an increase in measles cases, which have reached a 35-year high, with more than 95% of the cases among unvaccinated or those with unknown vaccination status, according to the Centers for Disease Control and Prevention. Measles vaccination, which began in the U.S. in 1963, reduced measles cases by 99.5% as of 2024. Read more here.

Beltway Report

At the Sept. 15 Senate Finance Committee hearing of Chris Klomp to be Deputy Secretary of Health and Human Services, Sen. Steve Daines (R-MT) expressed concerns about the negative impact of the proposed GLOBE and GUARD pricing models on the ability of smaller and mid-sized biotechs to engage in R&D and attract investment, “especially at this moment when China is rapidly closing the innovation gap and seeking to overtake the United States as a global leader in biotech.” In the same hearing, Klomp described the importance of the measles, mumps, rubella (MMR) vaccine, saying: “Unquestionably, the MMR vaccine is the single most effective public health tool that we have against measles.”

The Senate Health, Education, Labor & Pensions (HELP) Committee has scheduled a Sept. 24 hearing on Heidi Overton’s nomination to be Food and Drug Administration (FDA) Commissioner.