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Possible $170 Million for FDA Regulatory Science Initiative

August 20, 2010

ADVOCACY

HHS Secretary Kathleen Sebelius announced a new regulatory science initiative yesterday. We understand the program consists of $170 million for FDA but are trying to determine more specifics.

ANALYSIS AND COMMENTARY

It’s hot in DC and Congress is gone until September 13. It would be boring except the Executive Branch always seems willing to absorb the extra column inches that are freed up by Congressional recess. Thus, the report released yesterday by HHS Secretary Sebelius drew a lot of attention, but I didn’t read a single article that included a quote from a Member of Congress. The Alliance’s press release and our viewpoint can be viewed here.

Yesterday, the Secretary released the findings and recommendations from a top-to-bottom review of the Department’s efforts with regard to national security and the development of medical countermeasures (MCM). This means products that will decrease morbidity and mortality from a bioterror attack or from naturally occurring emerging infectious diseases. Think anthrax or radioactivity from a dirty bomb 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 MCMs once they are proven.

As with the larger promise of moving medical therapies from “bench to bedside,” there is no progress without FDA. The agency is supposed to encourage companies by helping them to define appropriate safety and efficacy endpoints for their particular MCM and work with them to resolve questions of animal models, lab standards, statistical plans, quality manufacturing, etc.

Then, the agency is charged with evaluating the results of testing and determine 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.

What is notable for us is that the Secretary (and the underlying report) found that there was insufficient funding of FDA’s efforts in this area. 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. There was also a recognition that FDA couldn’t do this job with its current resource level.

Even better, the Administration placed a price tag — $170 million for FY 10 and FY 11 — on the size and scope of the monies needed to upgrade FDA’s efforts in this area.  This is a substantial amount of money that will greatly increase FDA ability to fulfill its mission in the coming fiscal year (FY 11). We have been cautious in announcing this number because of uncertainties about where the money will come from and the degree to which Congress must still have its say.

What we know so far is that the Administration plans to transfer the $170 million to FDA from the funds previously appropriated to HHS to deal with pandemic flu. Apparently, HHS and OMB have agreed that the monies can be transferred as long as they retain their original purpose of helping to deal with pandemic flu. It seems likely they can do this, but there is no immediate way to determine if Members of Congress agree.

It is clear that the transferred funds cannot be used for non-pandemic medical countermeasures. To accomplish this will require a budget amendment to broaden the permitted uses of these funds. How likely is it that Congress will approve this? We probably won’t know for sure until after September 13.

Note: This analysis and commentary is written by Steven Grossman, Deputy Executive Director of the Alliance.

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