Lawmakers Seek to Boost FDA Power Over Fast-Tracked Drugs (1)

The FDA could remove from the market any drugs that obtained accelerated approval if they fail to show a clinical benefit under a proposed package reauthorizing must-pass user fee legislation.

The bipartisan proposal, unveiled Wednesday by leaders of the House Energy and Commerce Committee, would push sponsors of drugs approved through the accelerated pathway to complete required postmarket studies. Both the Food and Drug Administration and lawmakers have pushed for legislative changes to minimize the amount of time between when an accelerated approved drug enters the market and the completion of studies demonstrating if there’s a clinical benefit.

The ...