Woodcock Details Proposals to Spur Drug Competition and Curb Misuse

CDER Director Janet Woodcock flagged proposals in the FDA’s fiscal year 2020 budget designed to encourage drug competition and seal regulatory loopholes in testimony before a Senate drug pricing hearing.

Woodcock reminded members of the Senate’s Special Committee on Aging that the FDA has no direct role in pricing but said the agency is doing what it can to lower prices indirectly.

She highlighted a legislative proposal in the budget request that would impact the 180-day exclusivity available to first filers of medications. The proposed change would put a stop to first filers with deficient ANDAs that “game the system” to avoid losing exclusivity.