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Two-Tier OTC Monograph Approach Could Come With User Fee Revamp

 
• By Malcolm Spicer

One tier could provide two-year exclusivity, should FDA request clinical trials for new conditions or ingredients, under a US Senate discussion draft. Essentially stalled monograph process would be replaced by deadlines for FDA action in under two years.

Industry could have two tracks for seeking changes to OTC products marketed under the US monograph system: one for adding new ingredients or medical conditions treated by those ingredients, which would be eligible for exclusivity when clinical trials are required, and another for other types of changes.

The approach is proposed in a discussion draft of legislation to create a user fee program for OTC...

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