WASHINGTON — The Food and Drug Administration doesn’t have enough funding or staff to properly regulate pharmaceutical compounders, a top agency official said Friday, describing inspections that turned up “stuff floating around” in supposedly sterile shipments.

The program doesn’t “have adequate core staffing,” said Janet Woodcock, director of the Center for Drug Evaluation and Research, on Friday, adding that it’s one of the center’s programs that is “suffering the most.”

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.

  • I am a retired health care professional and I remain very interested in the
    areas of prescrip drug development and pricing and need for tighter regs
    over pharm development and physician scripts for meds not specifically
    approved for treatment of certain diagnoses. Impurities critical !

  • The FDA has utterly failed in it’s mission to protect public health. They chose to ignore this problem, even after all of those patents were injected with fungus tainted steroids. When Industry insiders decide where the regulations should be removed, while Congress under-funds necessary services, they are unable to function in the way they were intended to. This is what happens when science and facts are ignored to increase profitability.

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

Privacy Policy