Skip to Main Content

WASHINGTON — Food and Drug Administration Commissioner Scott Gottlieb defended his agency’s “breakthrough therapy” program, which speeds review of drugs that show signs of benefit early on, amid criticism from academics that the therapies aren’t actually breakthroughs at all.

A study published in late April in the Journal of Clinical Oncology showed that, on average, cancer drugs designated as “breakthrough” don’t help patients more than drugs that aren’t designated as “breakthrough.” And a study published earlier in April in the New England Journal of Medicine pointed out other examples of “breakthrough therapies” that really weren’t scientific breakthroughs.


Gottlieb said that there aren’t “any misgivings” around the program, and that it’s been “very important.”

Unlock this article by subscribing to STAT+ and enjoy your first 30 days free!