Amid ongoing interest among Americans to import drugs from other countries as well as continuing concern about a spate of recalled blood pressure medicines manufactured overseas, House and Senate lawmakers have asked the FDA to explain how it protects the pharmaceutical supply chain. At the same time, a bipartisan group from the House wants the Government Accountability Office to review the FDA inspection program.

In separate letters sent late last week, the lawmakers cited recent news reports about ongoing manufacturing problems at companies in China and India, which account for the majority of the active pharmaceutical ingredients used in medicines that are shipped to the U.S. They also pointed to a 2016 GAO report that found FDA oversight of foreign facilities was lacking.

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.

Leave a Comment

Please enter your name.
Please enter a comment.

  • One issue that has not been included in the dialogue on inspections is the number of MOU’s that US FDA has entered into in the last few years. Being able to accept the inspection reports of other national agencies might – I say “might” – allow the FDA focus on fewer targets, while still having more coverage.
    One may argue that they should then do just as many, just different ones, but a risk-based approach is supposed to allow a more focused effort. It will be more than interesting to see how this plays out, and if it is done in a substantive way.

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

Privacy Policy