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Ears ARE open on Capitol Hill … But …

March 12, 2012

Although Ladd Wiley, the Executive Director of the Alliance, has already done a number of Hill visits this year, my first ones were this week. It gave me some impressions that are worth passing on.

First, whether the budget situation is hopeless (as many believe), there are still Hill staffers willing to listen and try to help advance the funding of important programs, such as FDA. They are not unaware of the severe downward pressure, but believe that setting national priorities is still an important function of Congress. They are open to hearing why FDA may need increased funding in FY 13. No one is making promises, but doors are still open.

Second, we found staffers particularly interested in the ways in which FDA is different from other agencies. With more than 80% of FDA’s costs tied up in people (salary, benefits, rent, IT, training, etc.), the consequences of a flat budget (or worse) are far more severe than for most other agencies. Intuitively, staffers seemed to understand the breadth of FDA’s reach, but they were open to the reminder that FDA and FDA-regulated products touch every American many times each day.

Third, most people (not just staffers) have a hard time grasping the enormity of the globalization of FDA-regulated products. As Commissioner Hamburg pointed out in her Congressional testimony last week:

  • Nearly 40% of the drugs American take are made overseas; 80% of active pharmaceutical ingredients are imported into the U.S.
  • Approximately one-half of the medical devices used in the U.S. are imported.
  • Food imports have increased nine-fold since 1993;  70% of seafood and 35% of fresh produce in the U.S. comes from foreign countries.
  • FDA-regulated imported food products come from more than 300,000 foreign facilities located in 200 countries.

 Fourth, there was curiosity when we discussed the ways in which science is growing more complex — thus, requiring more time, manpower, and knowledge than in the past to perform a comparable activity (review an application for approval; evaluate a clinical trial, perform a field inspection, etc.). They had heard of nanotechnology, for example, but not the multiple ways in which FDA is involved because of this technology’s use in foods and cosmetics and proposed uses in other FDA-regulated products.

Finally, there was a need to educate staffers on the scope of FDA’s increasing responsibilities and why these require increased funding for the agency. I always try to make the point that not all new agency priorities come through legislation. Drug shortages, a new food pathogen, the imperative for bio-defense products, new sources of imports, and the advance of science … all place strains on the agency to do more and to do new things.

Staffers, of course, understood the legislative part of new FDA responsibilities. They were aware of the Food Safety Modernization Act and the need to fund its implementation. However, they were not as focused on the costs of the new biosimilars program (at least $20 million of which has to come from appropriated funding and not the new user fees). Nor were they thinking about the strain on resources still associated with requirements first put into law in the 2007 amendments (e.g., REMS and other post-market safety initiatives). Finally, staffers had not yet thought about how the user fee reauthorization legislation is likely to contain a number of new non-user fee FDA initiatives that will be unfunded mandates.

Conclusion: we have our work cut out for us. No program will have an easy time getting a funding increase in FY 13, but FDA has one of the best cases to be an exception. The Alliance is well-positioned to make that case. Please include FDA’s needs in your own Hill visits and please sign-up for Alliance lobby day on the Hill, scheduled for Wednesday, March 28.

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

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