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.