Health Law Highlights

Accelerated Approval Process Is Not Without Risk: Placing Recent FDA Action in Context

Summary of article from Troutman Pepper, by Kyle Dolinsky, Judith O’Grady:

The FDA withdrew approval for Pepaxto, a multiple myeloma drug, after post-marketing studies failed to confirm its clinical benefit. The drug had been granted accelerated approval, a pathway for drugs treating serious illnesses that offer therapeutic benefits over existing treatments. However, post-marketing studies are required to verify the drug’s benefit, and failure to do so can result in withdrawal of approval. This was the first time the FDA implemented formalized withdrawal procedures under the Food and Drug Omnibus Report Act of 2022. Despite the withdrawal, the risk of litigation concerning accelerated approval drugs remains unchanged.