Contribute Try STAT+ Today

At a time of heightened concern over abuse and dependence issues surrounding medicines, the Food and Drug Administration slammed a small drug maker for sending an email to physicians that appeared to “intentionally” omit any mention that its insomnia pill is a controlled substance.

In a Sept. 13 warning letter sent to Galt Pharmaceuticals, the agency complained to the company that the email made numerous claims about the benefits of its Doral pill for treating insomnia. But the email completely failed to mention the warning and precaution language in the prescribing label about the withdrawal syndrome associated with benzodiazepines, such as Doral.

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


What is it?

STAT+ 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
  • STAT+ Conversations
  • Weekly opportunities to engage with our reporters and leading industry experts in live video conversations
  • 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.