The U.S. Senate has agreed to reauthorize for five more years the array of federal biodefense programs created after 9/11. It does, however, have some significant differences from the programs reauthorized by the US House of Representatives during the fall.
The Senate approved a bill reauthorizing the Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization of 2011 (S.1855) from FY 2014 through FY 2018 three months after a somewhat similar measure passed the House. Both chambers passed the bills by voice vote, indicating consensus support for at least maintaining, and in some cases expanding, the biodefense programs.
As passed by the Senate, PAHPA renews the federal Special Reserve Fund (SRF) to purchase medical countermeasures against such diseases as anthrax, botulism, and smallpox for the Strategic National Stockpile. The SRF was created through the Project BioShield Act of 2004, one of two bills that are being renewed through the new legislation. The other is the Pandemic and All-Hazards Preparedness Act of 2006, which established the Biodefense Advanced Research and Development Authority (BARDA) within the U.S. Department of Health and Human Services (HHS).
Both the House and Senate versions of PAHPA Reauthorization would fund the SRF at $2.8 billion over five years. That's the same level as the $5.6 billion authorized under the original 10-year PAHPA. Three times since FY 2004, most recently in FY 2009, money from SRF was transferred to homeland security. And with the end of the first PAHPA authorization at the end of next fiscal year, it is expected that SRF will be fully drained, in part by the transfer of President Barack Obama’s FY 2013 budget for BARDA from the SRF as well as through approval of some procurement contracts slated for execution in the next fiscal year.
To discourage such draining of the fund in the reauthorized PAHPA, both the House and Senate versions require HHS to alert “appropriate committees of Congress” on the potential impact of diminished funding levels whenever the amount of BioShield funds available for procurement amounts to less than $1.5 billion. However, S.1855 requires a report to that effect within 30 days, compared with a 15-day deadline set by the House reauthorization measure, HR 2405.
More importantly, the Senate bill failed to adopt language within the House bill stating that if money is to be taken out of SRF, that money must be allocated toward advanced development BARDA funding. The House bill requires that any money shifted from SRF shall not be used to pay costs other than advanced development or procurement of a security countermeasure and should not be used for any administrative expenses including salaries.
“One can envision a possibility that money could be taken out of the SRF, which is for procurement—that's its intended use—and used for other things besides advanced development,” Phyllis Arthur, senior director, vaccines, immunotherapeutics, and diagnostics policy, for the Biotechnology Industry Organization (BIO), told GEN.
Both the House and Senate reauthorizations of PAHPA would create “regulatory management plans” (RMPs), through which drug developers can establish formal frameworks for obtaining scientific feedback from and interactions with officials regarding the development and regulatory review of countermeasures. Both bills require the RMPs to spell out the data that would be required for approval, including protocols and developmental milestones. RMPs are also supposed to help drug makers work through complex scientific issues such as developing animal models.
However, the Senate and House bills differ on details of what the RMPs should cover. The House bill requires RMPs for classic medical countermeasures (MCMs)—CBRN (chemical, biological, radiological, and nuclear) products—and makes them optional for pandemic and epidemic products like pandemic flu.
“The Senate bill is more of an opt-in for any product,” Arthur noted. “Companies can decide not to do an RMP or, in essence, it would be more of a mutually agreed decision on both parts to do one for any security countermeasure, be it pandemic flu or a regular classic MCM.”
The House and Senate bills include similar language emphasizing that RMPs should be agreed upon by the FDA and drug sponsors or applicants, with both sides communicating with each other to iron out areas of disagreement: “There needed to be some clarity on what do you have to do if you can't agree on the scientific criteria necessary to get the licensure. And so both bills now outline that,” Arthur said. But specifics on how to resolve disagreements will likely have to await the writing of detailed regulations implementing a reauthorized PAHPA, she added.
A conference committee will be needed to iron out differences in the PAHPA bills: The Senate bill requires FDA to take material threat determinations by the US Department of Homeland Security into consideration when reviewing products, putting into statutory language a practice of FDA’s Medical Countermeasures Initiative (MCMi), which was only expanded to CBRN last year.
The Senate measure specifically reauthorizes and lays out funding for the Strategic National Stockpile, managed by CDC, allocating $523 million a year over five years; establishes a “strategic investor” entity to promote public-private partnerships to develop MCMs; and also requires BARDA’s director to prioritize MCMs eligible for RMPs if the FDA determines that resources are not available for all MCMs seeking approval for the management plans.
None of those factors are in the House bill, which unlike the Senate requires HHS’ assistant secretary for preparedness and response to submit to the House Committee on Energy and Commerce and the Senate Committee on Health, Education, Labor, and Pensions a “Countermeasure Implementation Plan” describing the CBRN threats facing the nation “and the corresponding efforts to develop qualified countermeasures.”