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

More from Post-Marketing Regulation & Studies

More from Product Reviews