On July 3, 2023, Senators Bernie Sanders (I-Vt.), Chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee, Bill Cassidy, M.D. (R-La.), Ranking Member of the HELP Committee, Bob Casey (D-Pa.), and Mitt Romney (R-Utah) released a staff-level bipartisan discussion draft to reauthorize the Pandemic and All-Hazards Preparedness Act (PAHPA). PAHPA aims to improve the United States’ preparedness and response capabilities for future public health emergencies such as pandemics, natural disasters, and bioterrorism. First passed in 2006, PAHPA is set to expire on September 30, 2023, after two previous reauthorizations in 2013 and 2019. The draft seeks a reauthorization of five (5) years, meaning it would next expire at the end of fiscal year 2028. Notably, this will be PAHPA’s first reauthorization since the COVID-19 pandemic swept across the world, and it must be reauthorized to continue to support essential public health preparedness efforts.
In addition to the bipartisan draft, Ranking Member Cassidy released and requested immediate comments on a measure to extend and expand the Priority Review Voucher (PRV) program for material threat medical countermeasures (MTMCMs) (21 U.S.C. § 360bbb–4a), which is also set to expire on October 1, 2023. The MTMCM PRV program incentivizes the development of drugs that are used to prevent or mitigate harm caused by chemical, biological, radiological, and nuclear material (CBRN) threats. Under the MTMCM PRV program, when the Food and Drug Administration (FDA) approves a CBRN product that meets the statutory criteria, the sponsor will receive a PRV that entitles the holder to a six-month review of a future product, rather than the standard 10-month review cycle. Once awarded, a PRV holder may either apply the PRV to any subsequent qualifying application or sell the PRV to another company, which may then use it on their own subsequent application for any drug that would not otherwise receive priority review.
The additional revenue from either marketing a drug sooner or from selling the PRV significantly incentivizes drug sponsors to develop drugs for CBRN indications, in an area where there is little or no commercial market outside of the military and public health agencies. The draft measure seeks to amend the MTMCM PRV program by: (1) extending the program through fiscal year 2028; (2) providing a new, non-transferable PRV to companies that develop new medical countermeasures in addition to the transferable PRV they receive; and (3) broadening the statutory language to include threats to the Armed Forces.
Deadline for Comment
The HELP Committee seeks comments on the draft legislation. If you are interested in submitting a Comment, please do so by next Monday, July 10, 2023, at 10:00 a.m. ET to PAHPA2023Comments@help.senate.gov.
The Venable team has deep experience with the PRVs and the MTMCM PRV program in particular. We are available to answer any questions that you may have about the draft legislation, and we can also support the submission of any comments to the Committee. Please do not hesitate to contact our team members Jeremiah Kelly and Justin Coen.