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politico – Controversial drug approval fuels concerns over absence of standing FDA chief

“It’s an incredible loss of confidence in the transparency around the agency, especially the drug approval process” and “an abject leadership failure” on Woodcock’s part that the drug has been approved, said a former senior FDA official.

For years, critics have accused Woodcock of being too friendly with the industry it regulates, and that under it A decades-long tenure as the head of the FDA’s drugs division, the agency approved expensive new drugs without enough evidence that they were effective or safe. Several, including a drug for Duchenne muscular dystrophy and some cancer treatments, have yet to show results and have shown clear clinical benefit. Another approval under Woodcock – for Dsuvia, a potent fentanyl pill – has angered some in Congress and criticism from the FDAs external counselors for the worsening drug crisis.

“It’s not as black and white as people would like… these are tough decisions and there aren’t really any right answers,” Woodcock told POLITICO in April amid the latest controversy in the agency on drug approvals, in this case involving cancer drugs that did not show benefit against certain tumors after several years of marketing.

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 drug, known as aducanumab or Aduhelm, has thrown the FDA into a new wave of dissent and questioning from scientists, pundits and even Wall Street analysts. Three members of the FDA’s expert advisory group – who voted against the drug’s approval in November – have resigned in protest.

Longtime agency watchers say it was highly unusual for Woodcock, as acting commissioner, to remain publicly silent on the aducanumab decision.

“It’s hard to imagine that she didn’t play a role in this,” said Diana Zuckerman, president of the National Institute for Health Research. Over the years, “she was considered the most powerful person in the agency most of the time.”

Yet despite the backlash, there is little sign that it affected Woodcock’s position within the West Wing. Biden was happy with the move, according to two people familiar with his reaction, which comes as he pushes for new investments in the development of treatments for Alzheimer’s and other illnesses.

Biden is seeking $ 6.5 billion as part of his FY2022 budget request to create a new research group within the National Institutes of Health to accelerate work on Alzheimer’s disease, diabetes and the cancer.

Meanwhile, the White House has identified few viable alternatives to Woodcock for the top FDA post. The administration has approved former Obama-era FDA official Michelle McMurry-Heath for the commissioner’s role, several people familiar with the process said.

But McMurry-Heath has now led the pharmaceutical industry group Biotech Innovation Organization for a year, potentially making it harder to sell in a Democratic Party that advocates tackling drug prices. BIO in May criticized Biden’s decision to support the lifting of patents on Covid-19 vaccines and previously opposed the Trump administration’s efforts to curb drug prices.

Other former officials, including former Commissioners, insist Woodcock is still the best choice for the lead role.

“On the contrary, it should indicate that she is ready to make decisions that could be unpopular and difficult, even if they could harm her. For me that’s a big plus, not a minus, ”said a former senior health official, who noted that Woodcock likely left the decision to the agency’s drug reviewers. “I think what this tells you is that Janet is more focused on her job than on getting a job.”

The absence of a politically appointed commissioner could hamper the FDA’s ability to launch new initiatives or make major policy decisions like tobacco reform efforts. The agency is also reducing the backlog of factory inspections and drug and medical device approvals.

Pressure from Congress to find a permanent FDA chief continues to mount, with lawmakers on both sides wondering what is taking so long amid a global pandemic. Top Republican on the Senate Health Committee, Richard Burr of North Carolina, complained this week that it was high time Biden nominated an FDA candidate.

“I have the utmost respect for Janet Woodcock, she runs the FDA competently, and I think she has all the necessary qualifications at the moment, but we need someone who is fully confirmed in this role,” said he said during a hearing Tuesday on other Biden candidates.

Burr and other Republicans have said they will back Woodcock, a sign that she would be confirmed if she was nominated. But the The administration is loath to upset some Democrats who have criticized Woodcock for his opioid background, including the decisive vote of West Virginia 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 believe she is the right person for the job, and I will oppose it,” Senator Catherine Cortez Masto (D-Nev.) Told POLITICO.

Ed Markey of Massachusetts said he had “deep reservations,” while a spokesperson for Senator Maggie Hassan said the New Hampshire Democrat “continues to believe President Biden must propose an FDA commissioner who will act independently of the industry he regulates.”

“They don’t need Democrats to vote, they just need Democrats not to be really angry,” Zuckerman said of the administration.

Senators Elizabeth Warren of Massachusetts and Ron Wyden of Oregon – who are among the most vocal critics of the pharmaceutical industry in the Senate – have also avoided expressing support for Woodcock to lead the FDA on a permanent basis.

“I want to see who else is in the know,” Warren said of the area of ​​potential candidates to lead the agency, adding that she was out of Monday’s Alzheimer’s approval “very concerned about the process being used by the FDA “.

Wyden, who chairs the Finance Committee, recently spent days of blasting FDA decision-making, and said Thursday that a “critical measure” of its support for a potential candidate will be how they perceive the need for these drugs to be both effective and affordable .

In a brief interview Thursday, Biden’s Health Secretary Xavier Becerra would not commit to appointing a permanent chief of the FDA until August and suggested that this was largely a decision by the White House. Woodcock could only remain acting commissioner beyond August if the administration also made a formal appointment.

“This is something I would like to make sure to discuss with the White House [before answering]”He said.” We hope that at some point we will soon have the opportunity to present the candidate to the Senate. “

Becerra added that Woodcock has “served well as an actor,” but also appeared to distance himself from the agency’s decision to approve the Alzheimer’s drug.

“We rely on science when we make these kinds of calls, and because the FDA deserves a great deal of deference and independence in the way it acts, I think we’re all looking at how the FDA works. based on science, ”he said.

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