One of the bill’s key provisions is renewing the federal Special Reserve Fund to purchase medical countermeasures against such diseases as anthrax, botulism, and smallpox for the Strategic National Stockpile. [© pressmaster - Fotolia.com]
The array of federal biodefense programs created in the years after 9/11 is on track to remain in place through federal fiscal year 2018. There will also be some new provisions that officials hope will encourage more development of medical countermeasures that can be stockpiled for emergency use.
Earlier this month a House of Representatives bill (HR 2405) to reauthorize those biodefense programs for the next five federal fiscal years cleared the chamber on a simple voice vote. President Barack Obama’s administration has declared its support for HR 2405, adding that it “looks forward to working with Congress to improve and strengthen the bill, for example by authorizing a strategic investor for medical countermeasures, as its consideration shifts to the Senate.”
The Senate version of the Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization of 2011 (S.1855), introduced last month, was the subject of a closed-door “executive session” on December 14 by the chamber’s Committee on Health, Education, Labor, and Pensions, on its way to an expected approval by that chamber.
Among the bill’s most important provisions is renewing 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).
“The first legislation made these programs happen, and now the reauthorization is an issue of how to make them more operational and functional,” Dara Alpert Lieberman, senior government relations manager for the public health defense group Trust for America’s Health, told GEN.
Setting Funding Levels
Both the House and Senate versions of PAHPA Reauthorization would fund the SRF at $2.8 billion over five years, from FY 2014 through FY 2018. The original 10-year PAHPA authorized $5.6 billion.
“While certainly everybody would like to see the SRF be a little bigger in order to incentivize more industry, it’s actually a very reasonable number,” Phyllis Arthur, senior director, vaccines, immunotherapeutics, and diagnostics policy, for the Biotechnology Industry Organization (BIO), told GEN.
It remains to be seen how, if at all, the House and Senate will prevent Washington from draining the fund for other purposes. Three times since FY 2004, most recently in FY 2009, money from SRF was transferred to homeland security. Additionally, last year Sens. Richard Burr (R-NC), Judd Gregg (R-NH), and Joseph Lieberman (I-CT) introduced a bill that rescinded a $2 billion transfer from the SRF to fund increased education state aid.
To discourage such draining of the fund, both the House and Senate versions of PAHPA Reauthorization require HHS to alert 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. The House goes even further by stipulating that appropriations to the SRF are not available for use other than for payments made by the HHS Secretary to a vendor for advanced development or procurement of a security countermeasure or for associated administrative expenses.
Addressing Regulatory Concerns
Also in both the House and Senate versions of the PAHPA Reauthorization is language creating “regulatory management plans.” Through this drug developers can establish formal frameworks for obtaining scientific feedback from and interactions with officials regarding the development and regulatory review of countermeasures. While details differ, both bills require the plans to spell out the data that would be required for approval, including protocols and developmental milestones. The plans are also supposed to help drug makers work through complex scientific issues such as developing animal models.
“These are the kinds of timelines that interest industry,” Arthur noted. “It’s really just having consistency in terms of communication to and from the agency and consistency in feedback when trying to solve some of the regulatory hurdles. This is a good way to make sure that work is staying on track or that issues are being identified. If we’re not on track for certain portfolio products but there’s a good reason why a scientific hurdle hasn’t been accomplished, that would be identified in the report. It’s not really to blame; it’s more to track and to make sure that we understand where the priorities are over time.”
The Senate bill also clarifies FDA’s review process for medical countermeasures. It requires FDA to take material threat determinations by the US Department of Homeland Security into consideration when reviewing products. As Lieberman noted that would put into statute a practice of FDA’s Medical Countermeasures Initiative that was only expanded to CBRN (chemical, biological, radiological, and nuclear) in April; the $170 million program was launched in 2010 strictly for activities related to preparing for and responding to an influenza pandemic.
“The idea behind codifying was to make sure that those reviewers working on medical countermeasures were acutely aware of what the products they were working on were designed to do,” Arthur explained.
Also to that effect, Section 304 of the Senate bill charges the HHS secretary with accelerating countermeasure activities by ensuring the appropriate involvement of FDA personnel in interagency activities, ensuring FDA involvement and consultation in flexible manufacturing activities, and promoting the development of countermeasure expertise within FDA. Section 306 also requires the HHS secretary to submit an annual report detailing FDA’s medical countermeasure development and review activities, including identifying regulatory science priorities and scientific gaps.
Annual Budget Considerations Are Important
Closer coordination among government agencies and faster decisions will be essential if countermeasure developers are to spend a decade and roughly $1 billion to bring these drugs to market. To that extent PAHPA should prove helpful. How to achieve both will require more time to hash out in conference, since that accounts for many of the differences in the reauthorization bills.
“Because diseases or conditions requiring the use of CBRN countermeasures important to national security have historically occurred infrequently, manufacturers have asserted that a commercial market sufficient to justify investment in the development of CBRN countermeasures does not exist, and therefore economic incentive must be provided by the public sector by providing a guaranteed market,” Ryan C. Morhard, legal analyst with the Center for Biosecurity of UPMC, told GEN.
Obama’s administration has positioned itself as supportive of more biotech business activity in countermeasures. In 2010, HHS announced a strategy for its Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) that included encouraging translation of research; providing testing, development, and manufacturing services with mature pharmaceutical partners; and involving the federal government as a strategic partner and investor to countermeasure developers. That same year, the President’s Council of Advisors on Science and Technology issued its own study designed to speed up development of flu vaccines.
The proposed PAHPA Reauthorization will codify into law some of their recommendations, and in some cases, set funding for these and other biodefense priorities. Both the Senate and House bills, for example, call for plans to implement HHS’ PHEMCE strategy.
The most significant biodefense measures go beyond PAHPA legislation, however, to the annual budget bills that future Congresses will decide for all the agencies involved. So while PAHPA may set a fairly sound direction, a better indication of Congress’ commitment to biodefense will be as simple as following the money.