Weekly Policy Blog: PAHPA Reauthorization Advances Without Government Price Fixing
By: Colorado BioScience Association Date: 07/24/2023
Congress took important action on pandemic preparedness last week, advancing the Pandemic and All-Hazards Preparedness Act (PAHPA) reauthorization bills in both the Senate and the House ahead of its expiration on September 30th. CBSA met with and sent letters to the Colorado Congressional Delegation regarding concerns with the “reasonable pricing” clause proposed in the Senate Health, Education, Labor, & Pensions (HELP) Committee’s discussion draft, which would have negatively impacted public-private partnerships at BARDA and the CDC, so we were pleased to learn that those provisions were not included in the mark-up that advanced. CBSA, however, was disappointed to see that the PASTEUR Act, which CBSA has urged Congress to pass, was not included in the PAHPA reauthorization mark-ups.
The Current PAHPA
PAHPA put in place measures to ensure the United States is prepared for future pandemics, biothreats, and other public health emergencies. The current PAHPA must be reauthorized before the end of its five-year term, which expires on September 30th. CBSA supports PAHPA’s incentives to spur innovation and the development of new and faster response capabilities, such as the Medical Countermeasures (MCMs) Priority Review Voucher (PRV) program.
House Energy & Commerce Committee
The House Energy & Commerce Committee marked up two bills reauthorizing PAHPA on July 19th. H.R. 4420, the Preparedness and Response Reauthorization Act, and H.R. 4421, the Preparing for All Hazards and Pathogens Reauthorization Act, passed the committee on a party-line vote. Burdensome policies to address the problem of drug shortages were excluded, but there is still work to be done to ensure that drug shortages are addressed in an appropriate, responsible manner. In addition, Rep. Scott Peters (D-CA) criticized the bills for not including the PASTEUR Act, legislation which has been proposed to address the threat of antimicrobial resistance (AMR).
Senate HELP Committee
The Senate HELP Committee gave bipartisan approval in executive session on July 20th to a proposal for PAHPA reauthorization: S. 2333, Pandemic and All-Hazards Preparedness and Response Act. The bill’s incentives to promote research into MCMs include a clean five-year extension of the MCM PRV program and measures to support vaccine development and manufacturing. Two helpful amendments were also included in the version that ultimately passed the committee:
- Thanks to Sen. John Hickenlooper (D-CO), an amendment was added that would establish a program for reviewing MCMs for emerging pathogens at the Food and Drug Administration (FDA).
- An amendment from Sen. Ted Budd (R-NC) was added that would make changes to the management of the Strategic National Stockpile (SNS) of necessary medicines and supplies held in case of a health emergency, including a process to assess risks and reducing unnecessary reporting requirements.
Importantly, the version of the bill that moved forward did not include the government price fixing “reasonable pricing” clause that had been proposed in the Senate HELP Committee’s draft of the 2023 PAHPA reauthorization. In a letter sent to Sen. John Hickenlooper on July 12th, CBSA outlined its concerns with the “reasonable pricing” clause. Sections 601 and 602 in Chairman Sanders’ proposal would have required all Biomedical Advanced Research and Development Authority (BARDA) and Centers for Disease Control (CDC)-supported products be sold to the Federal Government or in the U.S. commercial market at the lowest price among G7 countries and at a “reasonable price.” These provisions would have effectively shut down private sector investment and the type of public-private partnerships that are vital to the development of life-saving MCMs, especially those that have a limited commercial market or no commercial market and rely on these partnerships.
The bills passed by each of the committees will next be heard by the full House and Senate. There will then be a reconciliation of the two versions before final congressional approval, which must take place before the September 30th expiration date of the current PAHPA.