One FDA Director Resigns, Another Reportedly Under Investigation

Big changes this week over at the Food and Drug Administration, where one high-ranking official has resigned amid concerns about approvals he authorized for questionable medical devices while another top official reportedly is under investigation for possible conflicts of interest.

All the internal turmoil may make for interesting water-cooler gossip around the hallways at FDA headquarters, but it’s clearly not news good for an agency that has been blasted with criticism in recent years for bumbling product recalls and new-drug approvals blamed for causing thousands of consumer deaths, illnesses, and injuries.

Schultz Shown the Door

Daniel Schultz, the head of the FDA’s medical device division, said Tuesday that he would be stepping down from the post. The move was said to be “by mutual agreement” with FDA Commissioner Margaret Hamburg, but we all know how that works: “Listen Dan, we’ll let you resign and won’t fire you, but ya gotta go.”

There’s been smoke coming from smoldering problems within the medical device division under Schultz for months. Earlier this year, nine experts told President Barack Obama that they had real serious concerns about medical devices that were rammed through the FDA approvals process despite concerns about their effectiveness and safety.

The scientists said they felt compelled by the FDA to vote in favor of approving the devices, even though they worried about the risks. National lawmakers are now looking into the accusations of wrongdoing by Schultz’s unit.

Woodcock Under Conflict Probe

In other FDA news, Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, reportedly is under investigation for an alleged conflict of interest, according to a report today in The Wall Street Journal. According to the Journal, the Health and Human Services inspector general is poking around after a company called Amphastar Pharmaceuticals complained that a competing firm, Momenta Pharmaceuticals, has been given special access to Woodcock.

The two companies compete in developing generic blood-thinning drugs. While the FDA said it is aware that there has been a claim of foul by Amphastar, officials are tight lipped and refusing to talk about it, the Journal reported.

So it’s been exciting and uncertain times for high-ranking employees at the FDA lately.

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