Alliance for a Stronger FDA

September 8, 2012

by Steven Grossman, Deputy Executive Director of Alliance for a Stronger FDA

Congress returns next week, which leaves them somewhere between 6 and 10 working days to write and approve an FY 13 Continuing Resolution before FY 12 appropriations run out on October 1. Assuming that the details can be worked out and sufficient votes gathered, the CR will run for 6 months and fund most programs (including FDA) at their FY 12 levels.

For FDA, this would mean a budget authority appropriation of $2.5 billion plus revenue from user fees. As has been widely reported in the trade press this week, special language will be needed in the CR for FDA to collect monies under the two new user fee programs — the one for generic drugs and the other for biosimilars — since they technically do not have a FY 12 existence to be “continued.”

…FDA is at risk of losing more than $200 million from its current appropriation — a devastating cut in the agency’s operations. If sequestration occurs: food will be less safe, drug and device approvals will be slower, problems with imports and globalization will become more numerous, and FDA modernization will be severely slowed (the opposite of what everyone, critics included, want).

The precise impact is hard to quantify because FDA will try to prioritize its remaining manpower and perhaps no immediate disasters will occur and no life-saving therapies will languish. But it is hard to imagine that anyone — including Congress and the President — thinks that the optimum FDA strategy is for the American people to rely on good luck when it comes to products under the agency’s jurisdiction…

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