BIOTERRORISM: FDA’s Pivotal Role Fighting Bioterrorism and Emerging Infectious Diseases

With Congress out of session until September 13, the Executive Branch has the opportunity to gain extra column inches and media bandwidth. Thus, last week’s report on medical countermeasures (MCM), released by HHS Secretary Sebelius, drew a lot of interest and a minimum of Congressional comment.
The Secretary released the findings and recommendations from a top-to-bottom review of the Department’s efforts with regard to the development of MCM. In the view of FDA Matters, the report thrusts FDA back into its rightful place as a key agency deserving more resources and respect for its national security responsibilities.
MCM are products that will decrease morbidity and mortality from a bioterror attack or from naturally occurring emerging infectious diseases. Think anthrax or radioactivity from an improvised nuclear device for the first, think H1N1 influenza for the second.
Scientifically and medically, these are difficult products to discover and develop. Financially, they won’t ever be developed without:
federal assistance to promising research; and
a strategic national stockpile and government contracts that will buy proven MCM’s.
As with the larger promise of moving medical therapies from “bench to bedside,” there is no progress without FDA. The agency encourages companies by helping them to define appropriate safety and efficacy endpoints for their particular MCM and works with them to resolve questions of animal models, lab standards, statistical plans, quality manufacturing, etc.
Then, the agency evaluates the testing results and determines whether to approve the product. This work has an additional wrinkle. With most MCM’s (maybe all) it is unethical to do human efficacy trials (e.g. intentionally expose a human being to anthrax to see if the MCM works). Instead, the agency (and the company) must make the difficult evaluation as to whether efficacy in animals is a sufficient surrogate for efficacy in humans.
The Secretary (and the underlying report) found that FDA’s efforts in this area are insufficiently funded. Perhaps for the first time, there was a more global recognition of FDA’s central role in making us safer from bioterrorism and naturally occurring emerging infectious diseases. The Secretary also recognized that FDA needs resources above its current level to do this job well.
The Administration placed a price tag–$170 million in funds to be available until expended–on the size and scope of the monies needed to upgrade FDA’s efforts in this area. The monies will come from dollars previously appropriated to HHS to combat pandemic flu. HHS and OMB have agreed that the monies can be transferred administratively as long as they retain their original purpose of helping to deal with pandemic flu.
However, the Secretary’s recommendation is for the transferred funds to also be used for non-pandemic medical countermeasures. This requires a budget amendment to be sent to Congress to broaden the permitted uses of these funds. How likely is Congress to approve this? We probably won’t know until after September 13.
http://www.fdamatters.com/?p=1095