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Two Tales from the City

June 26, 2010

ADVOCACY

Upcoming Meetings

  • Week of June 28. Karen Midthun, Director of Center for Biologics Evaluation and Research (CBER).

ANALYSIS AND COMMENTARY

There are two stories this week that bear on the fate of the FDA. The first was the announcement that the House Budget Committee would neither propose nor pass a budget resolution for FY 2011. The resolution is an annual requirement that sets targets for spending in this coming year, as well as providing a five-year forecast on spending. 

Even without a budget resolution, the committee is going to provide general guidance to the House: domestic spending should not exceed the President’s budget request minus $7 billion. We do not expect FDA to be affected  directly; but it would force even more competition among worthy programs fighting for a shrinking pot of money.

This reflects the prevailing mood throughout Capitol Hill.  Congressional leaders have decided the President’s restrained FY 2011 budget request isn’t restrained enough. I don’t think this reflects some broad consensus to pull back on programs that the President would “overfund.” Rather, it is premised on incumbents’ fears that they will look soft on spending … and feeling they can recover the high ground by being tougher than the President.

The appropriations process is largely stalled until Congress figures out whether the $7 billion in further cuts is enough.

The other story was an HHS Inspector General’s report on FDA oversight of foreign clinical trials. Put simply, FDA was criticized for not doing more to assure the integrity of sites, protocols and results and for not keeping track better. The agency agreed with the recommendations and now must find the funds to pay for more inspectors and a larger presence in this area.

These type of reports are almost a weekly occurrence — FDA is shown to have insufficient presence in an obvious area of need and the agency agrees (as it mostly should). The cost of improved oversight of foreign trials might be found somewhere in the FDA’s appropriations. The problem is the number of things the agency is being asked to do better. There is not enough money to cover all of them … not even close.

To me, the moral of these two stories is that we must continue to argue that FDA’s needs are (and must be) an exception to the drive for budget cutting.  The challenge is not just limited to FY 11 and Congress … we are also working hard with the Administration to give FDA a higher allotment in the FY 12 budget request being put together now.

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

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