After Aduhelm fallout, FDA veteran Woodcock out of running for commish job: report

Janet Woodcock, M.D., has spent more than three decades at the FDA, but her time running the agency as its interim leader is looking less likely to materialize into a full-time gig.

After the departure of Stephen Hahn, M.D., the former President Donald Trump pick for FDA commissioner, President Joe Biden installed Woodcock into the chair for the short term as he looked for a replacement.

Many thought Woodcock would be a shoo-in, but as we approach Nov. 15 when her temporary term is up, a report out by Bloomberg says the White House has now dismissed her as a candidate.

This also seems borne out by the fact that during the worst pandemic in more than a century, with the FDA front and center (though sometimes behind the president) in authorizing or approving new drugs and vaccines, we still have no full-time commissioner. It would seem easy to simply move Woodcock into that role and have her confirmed, and get on with the job of dealing with the pandemic.

But that hasn’t happened. Woodcock “has been ruled out as permanent head of the Food and Drug Administration,” people familiar with the matter have told Bloomberg, as it looks to parachute someone in to help fully approve new COVID drugs and vaccines, which will widen the scope of their use.

The report in Bloomberg notes that she has faced “firm opposition on Capitol Hill,” notably from Sen. Joe Manchin, D-West Virginia, a key swing vote in the evenly divided chamber.

RELATED: FDA veteran Woodcock takes over as acting commissioner in Biden administration

He, like others, has lashed out at Woodcock, seen by some as being a little too cozy with pharma, for her decision to allow the speedy approval of Biogen’s highly controversial Alzheimer’s disease drug Aduhelm, a drug that has mixed trial data at best yet was given a fairly broad OK by the agency.

This also came despite the expert advisory committee review saying it should not be approved, meaning the agency went against this advice.

Woodcock has overseen an exodus of talent from that Aduhelm AdComm who left in anger over the drug’s approval. She’s also losing a top official in Ellis Unger, M.D., a cardiologist who led the agency’s Office of Drug Evaluation I, who is retiring after 25 years at the agency.

Unger is retiring for “personal reasons” and not in response to the Aduhelm approval, but that still leaves some major shoes to fill.

While the White House hasn’t publicly ruled out Woodcock, officials “have privately concluded that she won’t be the nominee, said the people, who discussed the matter on condition of anonymity,” Bloomberg said.

Despite the urgency, the government still appears happy to have Woodcock remain as acting commissioner: Biden isn’t expected to announce a nominee in the immediate future, the people told the paper.

Six former FDA commissioners banded together in March to urge Biden to appoint a full-time leader, noting vaccine, drug and testing issues related to the pandemic as well as the need to implement new tobacco regulations.

The ex-commissioners did not endorse any one candidate in their letter to the White House, but they did praise Woodcock, who led CDER from 1994 to 2005 and from 2008 until January 2021.