Great unknowns

PDUFA reauthorization passed a major milestone last week when the U.S. Senate's expert committee voted 15-5 in favor of a bill that extends drug and device user fees for five years and revamps drug safety oversight. But the final shape and impact of the legislation is still not clear.

PDUFA IV and associated legislation will certainly move the U.S. into an era of total lifecycle regulation for prescription drugs, and newly inserted provisions promise to increase the transparency of FDA deliberations.

The most important unknowns in the PDUFA IV equation are the balance Congress will strike between precautionary and data-driven safety regulation, and whether the myriad statutory changes will work as intended or if they will end up unnecessarily delaying the development and review of new drugs.

At this point, both FDA and industry believe that without substantial revisions, the Food and Drug Administration Revitalization Act (S. 1082) would gum up the regulatory machinery, creating counterproductive hurdles to developing new drugs.

S. 1082

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