FDA head resigns after presiding over record approvals

Dive Brief:

  • Margaret A. Hamburg has announced her March resignation as commissioner of the Food and Drug Administration. Hamburg presided for six years as the reach of the FDA expanded extensively to regulate the tobacco industry and revamp the country's food-safety system. Perhaps most notably, Hamburg led the FDA in stepping up the pace of drug approvals.
  • Hamburg's six years make her one of the longest-serving FDA commissioners of the past few decades. 
  • Stephen Ostroff, FDA chief scientist, will step up as acting commissioner. Potential candidates to take Hamburg's position could include other recently-hired top FDA officials.

​Dive Insight:

Hamburg's leadership was sometimes controversial, on subjects including unregulated "compounding" pharmacies and the FDA's approval of painkillers argued to be contributing to the prescription drug epidemic.

The FDA's increased drug approvals have included "breakthrough" medications for conditions including cancer and cystic fibrosis. The Pharmaceutical Research and Manufacturers of America (PhRMA), praised Hamburg to the Washington Post for her "thoughtful regulation of medicines" and her "strong leadership."

However, not everyone is a fan.

"I'm pleased to see her go," Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing told the Post. "Her administration consistently put the interests of the drug companies ahead of public health."

Filed Under: Policy & Regulation
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