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Playing “Catch-Up”: A Multi-Year Effort

March 27, 2010

ADVOCACY

Alliance Written Testimony for Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies.   Please click here to see the written testimony that the Alliance submitted to the Subcommittee regarding FY 11 appropriations.

Friends of Cancer Research/FasterCures Hill Briefing. Alliance member organizations Friends of Cancer Research and FasterCures held a briefing this past week regarding the need to bolster FDA’s scientific capacity.  Congresswoman Rosa DeLauro gave remarks at the briefing and the panel included Alliance Board Member Ellen Sigal of Friends of Cancer Research and was moderated by Alliance Board Member Margaret Anderson of FasterCures. Increased FDA funding was a major theme of the event.

Upcoming: FDA Public Workshop on Measuring Progress on Food Safety (Tuesday March 30, 2010). For more details on the workshop Please click here for more on the FDA’s initiatives in this area.  

ANALYSIS AND COMMENTARY

With generous increases in funding, FDA can be better each year, but it may never “catch up.” New responsibilities, new scientific complexity, and new information are always going to make FDA’s workplan more labor-intensive and expensive than the prior year. Plus the fixed costs of the agency’s core capacity increase every year.

New responsibilities. As part of health reform, FDA has several new responsibilities. The largest is the creation of an approval pathway for follow-on biologics. This is going to require a lot of manpower to:

  • Implement this complex new law through regulations and guidances;
  • Generate the knowledge within FDA sufficient to regulate an expanded range of biological products; and
  • Negotiate requirements with individual sponsors and evaluate their applications.  

And as all Alliance members know, more responsibilities require more manpower, which means more funding. Over 80% of the agency’s costs are people-related (salaries, benefits, rent, IT, training, etc.)

New scientific complexity. One of Commissioner Hamburg’s key initiatives in the FY 11 budget request is for “advancing regulatory science.” Her proposal for $25 million is a good start, but just the beginning. The need is probably 6 to 10 times as great. FDA needs to know its science. Biology (drug development, food safety), chemistry (manufacturing, diagnostics, cosmetics), and physics (medical devices, radiation-emitting products) are dynamic fields. New knowledge (and usually more complex knowledge) is an every-day event. It might take FDA a number of years to build the culture of science it needs and have all the tools in place. Even then, the knowledge and the tools will change every day and require increased effort.  Please click here for more on the FDA’s initiatives in this area.  

New information. We often talk about FDA’s IT needs, meaning both day-to-day working capacity and the larger data and tracking databases that improve FDA decision-making. We tend to think of these as capital investments in hardware and software … and some more staff to make the systems work well. There is more: staff to analyze and form recommendations based on the new information coming into the agency through these new data and tracking systems. For example, FDA will eventually have information on hundreds of millions of patient encounters involving pharmaceuticals. This will be worthless without dozens (and eventually hundreds) of analysts to sift valuable insights and actionable knowledge from the mountains of data.  

The fact that FDA may never “catch up” is a challenge for us as advocates. Every extra appropriated dollar moves FDA forward; lean years take us backward against a rapidly moving target. From the beginning, the Alliance has stressed that our cause is a multi-year endeavor. Even as we succeed in getting the agency more resources, more years stretch before us. We are grateful that the Alliance members understand and are committed to long-term advocacy.  

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

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