Just a Few More Things for FDA to Focus on
Two of the continuing themes of the Alliance are:
- The need for Congress to exceptionalize FDA and provide it with funding increases regardless of how other agencies fare, and
- The clear consensus in Congress that FDA’s job is important and needs to expand (yet it often feels like there is a disconnect with the dollars provided)
Both were on display at the House full committee mark-up on June 13 and in the Committee’s report.
FDA is still slated to receive the amount passed by the subcommittee a week ago. Although it is well above FDA’s post-sequester FY 13 funding level, the proposed funding for FY 14 does not even match the FDA’s FY 12 base funding. So, the agency needs more money than the House level, but we also recognize that FDA appears to be the only major discretionary program in the Ag/FDA appropriation to receive an increase above the FY 13 enacted level. Many agriculture programs did not even receive that amount.
The Committee report contained a large number of programmatic requests. The committee expressed concern about “the unpredictable nature and pace at which FDA moves guidance, rules, and regulations through the process.” Where OMB review may significantly slow the process, the House is suggesting that the agency consider using advisories and guidances to inform consumers and industry more quickly on critical public health issues.
The committee also provided direction to FDA (mostly to hurry things up or consider certain factors and issues) on: non-tropical diseases, animal antimicrobials, nutrition labeling, food safety monitoring, tobacco products (cigars), sunscreen, new dietary ingredients, food safety centers of excellence, cosmetics and lead, drug shortages, food and veterinary medicine, compounded drugs, food product tracing, premarket review of tobacco products, low-risk, expedited imports, cough and cold products for children, antibiotic data collection, seafood, mammography, canned tuna, impact on small businesses of the generic drug user fee, and abuse-deterrent drugs.
I haven’t checked against prior years, but it seems like a particularly long list. Whether any specific item is meritorious, the overall effect seems good for FDA. The committee may have things it wants done, but it cares what happens and is clear that “what FDA does” matters to the world.
The mark-up showed the same priority and concern about FDA issues. Committee members reached a consensus that user fees should not be sequestered, although no specific solution has yet been adopted. Other topics discussed in committee included the artificial pancreas, food additive petitions, and the pediatric device consortia grant program.
Step back for a second (as we hope the committee did) and look at the incredible range of issues that FDA must deal with. That’s why the agency needs the resources and why we advocate on their behalf.
Note: This analysis and commentary is written by Steven Grossman, the Deputy Executive Director of the Alliance for a Stronger FDA.