Skip to Main Content
Contribute Try STAT+ Today

The next chapter in an unusual saga involving a high-priced, rare disease drug will play out in a federal court, where Catalyst Pharmaceuticals (CPRX) has accused the Food and Drug Administration of violating the law when it recently approved a similar medicine made by a small, family-run company. And the battle is being closely watched for clues that incentives for developing such drugs may be jeopardized.

In its lawsuit, Catalyst alleges the FDA “arbitrarily and capriciously” approved the other medicine, which is made by Jacobus Pharmaceutical, by applying different standards. Moreover, the agency unfairly trampled on Catalyst’s right to seven years of exclusive marketing, a designation for so-called orphan drugs that treat small numbers of patients, according to the lawsuit.

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.