"A Rising Tide Lifts All Boats"
ADVOCACY
Upcoming Meetings
Next week the Alliance is meeting with the staff of Congresswoman Rosa DeLauro (D-CT), Chairwoman of the House Agriculture-FDA Appropriations Subcommittee.
In early June the Alliance is scheduled to meet with officials at the Office of Management and Budget.
Food Subgroup Conference Call (Wednesday, May 26th at 3:30 Eastern): Resource Implications of Pending Food Legislation.
ANALYSIS AND COMMENTARY
Since the Alliance’s founding in 2006, we have always stressed the need to support FDA as a whole. The founders and early members of the Alliance believed strongly that “a rising tide lifts all boats.” It remains a part of our organizational DNA. Given the growth of user fees, it has become even more important to advocate for the appropriated funding that supports all of FDA’s core public health mission.We see no conflict in Alliance members also being advocates for their own area of FDA. We encourage them to put that advocacy in the context of Alliance recommendations for funding the entire FDA. Our only real concern is that members not advocate for their own area of FDA at the expense of other parts of the agency.So, it has been troubling that, on a few occasions, we have heard people say that rising appropriations for foods has been at the expense of drugs and biologics. I have done the analysis, comparing FY 02, FY 07 and FY 10. Here are some of the conclusions:
Combining center activities, field activities and user fees: over this 8-year period, funding for food activities has actually declined slightly compared to CDER/CBER.
Including user fees, but excluding field activities (monies that go directly to the Office of Regulatory Affairs for inspections and enforcement): the core functions of CDER and CBER have done far better than the food core functions (mostly CFSAN).
Excluding user fees and field activities: for the eight-year period, CFSAN and food activities grew by 60%, CDER/CBER by 57%. For the last three years, CFSAN and food activities have grown by 67% compared to 69% for human drugs and biologics. In effect, the food center and drugs centers have been treated almost identically for the core appropriations.
Looking ahead? In the President’s FY 11 request, the proposed appropriations increase for CFSAN is larger than for CDER and CBER combined. However, all of the differential is in 87 people and $40 million that is being proposed for new food inspectors. If ORA is excluded, as well as user fees, the food increase and the drug/biologics increases are about equal.The complete analysis can be found in an article entitled “Center-Envy: Are Foods Doing Better than Drugs?” It’s conclusion goes beyond Alliance policy, but is consistent with what we believe: center-envy is bad in its own right, but even worse when it is based on misinformation and misperceptions.So, the next time you are asked: who’s doing better, I hope you will respond: the core food and drug functions are growing at similar rates.
Note: This analysis and commentary is written by Steven Grossman, Deputy Executive Director of the Alliance. Mr. Grossman is also the author of the blog, FDA Matters, where the full analysis mentioned above appears. The blog is a product of his consulting practice and is not affiliated with the Alliance. The opinions expressed on the blog are solely his own.