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.

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


What is it?

STAT Plus is STAT's premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.

What's included?

  • Daily reporting and analysis
  • The most comprehensive industry coverage from a powerhouse team of reporters
  • Subscriber-only newsletters
  • Daily newsletters to brief you on the most important industry news of the day
  • Online intelligence briefings
  • Frequent opportunities to engage with veteran beat reporters and industry experts
  • Exclusive industry events
  • Premium access to subscriber-only networking events around the country
  • The best reporters in the industry
  • The most trusted and well-connected newsroom in the health care industry
  • And much more
  • Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr.

A roundup of STAT’s top stories of the day in science and medicine

Privacy Policy