"It's an incredible loss of confidence in transparency around the agency, in particular the drug approval process” and “an abject failure of leadership” on Woodcock’s part that the drug was approved, said a former senior FDA official.
Critics for years have accused Woodcock of being too friendly with the industry she regulates, and that under her decadeslong tenure heading FDA’s drug division the agency approved new, expensive medicines without enough evidence they were effective or safe. Several, including a Duchenne muscular dystrophy medicine and certain cancer treatments, have yet to pan out and show clear clinical benefit. Another approval under Woodcock — for Dsuvia, a potent fentanyl pill — has drawn the ire of some in Congress and criticism from FDA’s outside advisors for worsening the addiction crisis.
“It isn't as black and white as people would like ... these are hard decisions and there's no really right answers,” Woodcock told POLITICO in April amid the agency’s last controversy over drug approvals, in that case involving cancer medicines that did not show benefit against certain tumors after several years on the market.
The White House did not respond to a request for comment for this story. An FDA spokesperson declined to comment.
Monday’s decision on the Alzheimer’s medicine, known as aducanumab or Aduhelm, threw the FDA into a fresh round of dissension and second-guessing from scientists, experts and even Wall Street analysts. Three members of FDA’s expert advisory panel — which voted against approving the drug in November — resigned in protest.
Longtime observers of the agency say it was highly unusual for Woodcock, as acting commissioner, to stay publicly silent about the aducanumab decision.
“It’s hard to imagine that she didn’t have a role in this,” said Diana Zuckerman, president of the National Center for Health Research. Throughout the years, “she has been considered the person who was the most powerful at the agency, most of the time.”
Yet despite the blowback, there's little sign it has affected Woodcock's standing within the West Wing. Biden was pleased with the decision, according to two people familiar with his reaction, which comes as he's pushed for fresh investment in developing treatments for Alzheimer's and other diseases.
Biden is seeking $6.5 billion as part of his fiscal 2022 budget request to create a new research group within the National Institutes of Health aimed at accelerating work on Alzheimer's, diabetes and cancer.
Meanwhile, the White House has identified few viable alternatives to Woodcock for the top FDA job. The administration has vetted former Obama-era FDA official Michelle McMurry-Heath for the commissioner role, several people familiar with the process said.
But McMurry-Heath has now run the pharmaceutical industry group Biotech Innovation Organization for the past year, potentially making her a harder sell within a Democratic Party that's advocated cracking down on drug prices. BIO in May criticized Biden's decision to support waiving patents on Covid-19 vaccines and previously opposed Trump administration efforts to rein in drug prices.
Other former officials, including past commissioners, insist that Woodcock is still the best pick for the top role.
“If anything, it should signal that she’s willing to make what could be unpopular and hard decisions even when they might negatively blow back on her. To me, that’s a big plus, not a minus,” said one former senior health official, who noted that Woodcock likely left the decision up to the agency’s drug reviewers. “I think mostly what this tells you is Janet is more focused on her job than winning a job.”
The lack of a politically appointed commissioner could hinder the FDA's ability to launch new initiatives or make major policy decisions like tobacco reform efforts. The agency is also whittling away a backlog of plant inspections and drug and medical device approvals.
Congressional pressure to find a permanent FDA chief continues to mount, with lawmakers from both parties questioning what’s taking so long amid a global pandemic. The Senate health committee’s top Republican, Richard Burr of North Carolina, complained this week that it was long past time for Biden to name an FDA nominee.
“I have the greatest respect for Janet Woodcock, she is leading the FDA ably, and I think she has all of the qualifications needed for this moment, but we need a fully confirmed person in that role,” he said in a Tuesday hearing on other Biden nominees.
Burr and other Republicans have said they would back Woodcock, a sign that she would be confirmed if nominated. But the administration is loath to antagonize some Democrats who’ve been critical of Woodcock over her track record on opioids, including West Virginia’s key swing vote, Joe Manchin, whose state has been ravaged by the drug crisis.
Three other Democratic senators have also linked Woodcock to their concerns about the opioid epidemic.
“I don’t trust her judgment, I don’t trust that she is the right person for the job, and I will oppose it,” Sen. Catherine Cortez Masto (D-Nev.) told POLITICO.
Ed Markey from Massachusetts said he has “deep reservations,“ while a spokesperson for Sen. Maggie Hassan said the New Hampshire Democrat “continues to believe that President Biden needs to put forward an FDA commissioner who will act independently from the industry that he or she regulates.”
“They don’t need Democrats to vote, they just need Democrats not to be really angry,” Zuckerman said of the administration.
Sens. Elizabeth Warren of Massachusetts and Ron Wyden of Oregon — who rank among the Senate's most outspoken drug industry critics — similarly shied away from voicing support for Woodcock to run the FDA on a permanent basis.
"I want to see who else is up on this," Warren said of the field of potential candidates to run the agency, adding that she came away from Monday's Alzheimer's approval "very concerned about the process that the FDA has used."
Wyden, who chairs the Finance Committee, has spent recent days blasting the FDA's decisionmaking, and on Thursday said a "critical measure" of his support for an eventual nominee will be how they view the need for such drugs to be both effective and affordable.
In a brief interview on Thursday, Biden health secretary Xavier Becerra would not commit to nominating a permanent FDA head before August, and suggested it is largely a White House decision. Woodcock could only remain acting commissioner beyond August if the administration has also made an official nomination.
"That's something I would want to make sure to discuss with the White House [before answering]," he said. "We hope at some point soon we'll have the opportunity to present the nominee to the Senate."
Becerra added that Woodcock has "served well as acting," but also appeared to distance himself from the agency's decision to approve the Alzheimer's drug.
"We rely on the science when we make these kinds of calls, and because the FDA is entitled to a great deal of deference and independence in the way that it acts, I think all of us are looking to hear just how the FDA operates based on the science," he said.