US FDA Urged To Improve Messaging To Professional Societies On Accelerated Approval Withdrawals

The US Food and Drug Administration should be more forceful in its communications to professional societies about accelerated approval drugs which have failed to confirm clinical benefit and for which withdrawal is being proposed.

The sometimes lengthy interval between the agency’s proposal to pull a drug’s marketing approval and the actual withdrawal creates an opening for the FDA to better convey its concerns about the medicine’s benefit-risk profile in a way that impacts prescribing guidelines, Joshua Sharfstein, vice dean for public health practice and community engagement at