FDA to drop two-study rule for new drug approvals
The Food and Drug Administration (FDA) plans to drop its longtime standard of requiring two rigorous studies to win approval for new drugs, the latest change from Trump administration officials vowing to speed up the availability of certain medical products.
Going forward, the FDA’s “default position” will be to require one study for new drugs and other novel health products, FDA Commissioner Dr. Marty Makary and a top deputy, Dr. Vinay Prasad, wrote in a New England Journal of Medicine piece published on Wednesday.
The announcement is the latest example of Makary and his team changing long-standing FDA standards and procedures to slash bureaucracy and accelerate the availability of new medicines.
Since arriving at the agency last April, Makary has launched a series of directives that he says will shorten FDA reviews, including mandating the use of artificial intelligence by staffers and offering one-month drug assessments for new medications that serve “national interests.”
It contrasts with the FDA’s more restrictive approach to other products, including vaccines.
Makary and Prasad said dropping the two-trial requirement reflects modern advances that have made drug research “increasingly precise and scientific.”
The latest approach contrasts with the FDA’s recent actions on vaccines, gene therapies, and other treatments.
