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Focusing on the Goals for the New Year

January 8, 2010

ANALYSIS AND COMMENTARY

In FY 10, FDA’s appropriation will support about 9,100 full-time employees. This is the same personnel level as 1994, which was the previous high-water mark. This statistic (courtesy of Sam Baker at FDA Week) is yet another confirmation that FDA remains substantially underfunded. The growth in the last few years needs to be seen as a down payment on what still needs to be accomplished.

In the intervening 16 years, FDA has been given a large number of  new responsibilities. And doing it’s everyday job is considerably more labor-intensive because of the increased complexity of science and the globalization of the food and drug industries.

To be accurate, the agency does have more total resources than in 1994 because user fees add about 2,600 employees. Even for user fee fans, this still leads to what should be an unhappy conclusion: the public contribution to FDA (as reflected in personnel levels) has not increased since the first user fee program kicked in.

In prior columns, I have pointed to three possible barriers to getting FDA a substantial increase in the  FY 11 appropriations process:

  • President Obama will be emphasizing deficit reduction in his FY 11 budget requests.
  • FDA may not get as much attention from appropriators as they struggle with funding new legislation, particularly health reform. The PDUFA reauthorization cycle starts again in a few months and this will also be a distraction.
  • In a tight year, Congress often underfunds agencies that have had above-average increases over the prior 2 or 3 appropriations cycles, figuring the agency can use an extra year to absorb increases and manage growth.

Another concern is the role of unfunded mandates. If Congress appropriates $400 million dollars for FDA, we might be very happy. However, if the agency must absorb $250 million dollars for new functions (e.g., food safety, follow-on biologics, etc.), then the net increase for core programs is only about $150 million. At 6% annual inflation in FDA costs (the OMB-approved number), about $140 million of that will be needed just to sustain program levels. ,

In the face of these barriers, and knowing that appropriated personnel levels haven’t grown in 16 years, the Alliance (and its members) need to be continuously reinforcing that “strengthening FDA” is a work in progress. The job is not nearly done.

Who needs to hear this message?  The Alliance’s focus is the Administration, Congress and the media. We need your participation and support to make this happen.

Now is also the time to bulk up the Alliance’s  membership … our 180 members is impressive to Hill staff. Having 250 members would command even more respect. Please think about who else should belong, then pick up the phone or send an e-mail. Ladd and I will be happy to follow-up with more information and to chat about the past accomplishments and future goals of the Alliance.

Ladd, Tony and I wish everyone a happy and healthy new year.

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

MEDIA/NEWS

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