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OTC Monograph User Fees Still On The Table, But Not In Legislation

 
• By Malcolm Spicer

FDA’s Aug. 23 webinar will update industry stakeholders on progress to modernize its OTC monograph program, but without user fee legislation, new performance goals will not take effect; stakeholders hold out hope a standalone OTC user fee bill could still progress in Congress.

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FDA will not be able to implement its proposed OTC monograph reform and user fee rules on Oct. 1, the start of US federal fiscal year 2018, because those changes were contingent on Congress passing enabling legislation.

So far, such legislation has not made it beyond the discussion stage, either as an independent bill or as part...

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