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The FDA Budget for FY 11: Moving Forward

February 5, 2010

ADVOCACY

REMINDER: Alliance Member Meeting. Tuesday, February 9th at 2:00 pm.

Agriculture Appropriators Meetings. Next week the Alliance is set to meet with the staff of the following members:

  • Senator Richard Durbin (D-IL) — on Monday
  • Senator Susan Collins (R-ME) — on Monday
  • Senator Mitch McConnell (R-KY) — on Wednesday
  • Professional staff of Senate Agriculture Appropriation Subcommittee — on Wednesday
  • Senator Christopher Bond (R-MO) — on Wednesday

House Agriculture Appropriations Subcommittee Hearing on FDA Budget. Wednesday, February 10th at 10:00 am.

Meeting with Josh Sharfstein, FDA Principal Deputy Commissioner. The Alliance is also meeting with Dr. Sharfstein next week to discuss ways to measure improvements at the agency.

ANALYSIS AND COMMENTARY

This will be a tough budget year for the FDA. The proposed 6% increase in the President’s budget request is a great first step. More funds are needed. The Alliance’s position is clear: good year or bad, the strength of the FDA needs to be a public priority.

Everyone in the FDA stakeholder community agrees with this. Or so I thought. There appears to be a small group of naysayers. They believe the agency has grown too fast. They say: FDA should take a break for a year or two, consolidate its gains, then grow again.

On its face, this may seem reasonable. In fact, it is dangerous thinking that risks our nation’s health and safety. It could also lead to yet another lost decade for the agency.

These are strong words, but ones I believe in.

In FY 10, FDA’s appropriation supported as many full-time equivalent (FTE) employees as in 1994, the agency’s peak year. Given how much the world has changed (scientific complexity, globalization, volume of products, etc.), how can the same number of FDA employees be expected to get today’s job done?  Simply put, they can’t. More employees will be needed and that requires an increase in the appropriations part of the FDA budget.

Has the agency reached full strength on nanotechnology, regulatory science, bioinformatics or biomarkers? Has it fully incorporated personalized medicine, global food distribution or fighting obesity into its thinking? What about the need to encourage innovation? Are there no more places around the world where FDA needs to have offices? Is the agency ready for follow-on biologics and a revamped food safety system? Do we think we have enough inspectors?

I can go on for paragraphs, but the point should be clear: FDA’s job is rapidly expanding in an ever more complex world.

There are definitely issues managing and harnessing a growing workforce, but these are ones that Commissioner Hamburg can deal with. She is an experienced administrator and understands what is needed.

All the risk is the other way, in not growing each year to meet the growing challenges of FDA’s mission. This is not the last tough budget year; it is the first of many. To give up for one or two years … risks the loss of momentum at a time when lawmakers will be desperate to find places to trim the federal budget.

FDA is already behind. Years without new personnel are years where we lose more ground.

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

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