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Accelerated Approval Reform Target? Makena Hearing Highlights Product Promotion During Withdrawal Period

 
• By Sarah Karlin-Smith

Makena hearing and the product’s prolonged withdrawal process raises questions about whether FDA needs new authorities to curtail advertisement and ensure accurate patient and provider education after an accelerated approval drug’s confirmatory trial fails and/or during the period in which the agency is considering pulling the product from the market. 

Makena hearing marketing
Communication on accelerated approval drugs post confirmatory trial failure may be ripe for regulatory reform. • Source: Shutterstock

The US Food and Drug Administration’s accelerated approval withdrawal hearing for Covis Pharma’s preterm birth drug Makena highlighted a regulatory gap – as the FDA slowly completes the steps required to pull a medication from market, a company can promote the product as it sees fit, no mention of the drug’s perilous approval status required.

The House-passed accelerated approval reform bill, cleared as part of FDA’s broader user fee renewal package in June, included new...

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