Crunch time for FDA user fees as reau­tho­riza­tion looks to hitch a ride on short-term spend­ing bill

The lifeblood of the FDA’s drug re­views — the user fees that in­dus­try pays FDA for time­ly re­views of new and gener­ic drugs over five-year pe­ri­ods — must be reau­tho­rized be­fore the end of this month or else re­views and ap­provals will grind to a halt quick­ly, with thou­sands laid off at the agency.

While the FDA says it’s ex­pect­ing a deal to get done, what’s ex­act­ly in that deal re­mains to be seen, as sources said they haven’t seen any bill text yet, and Re­pub­li­cans have sought a bill clean of all rid­ers, in­clud­ing one that would re­form the ac­cel­er­at­ed ap­proval path­way, linked to an­oth­er short-term gov­ern­ment spend­ing bill.

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