Controversial drug approval raises concerns about a shortage of permanent FDA chiefs

“This is an incredible loss of confidence in the transparency of the authorities, especially in the drug approval process,” said a former FDA official, “a terrible failure of leadership” on Woodcock’s side that the drug was approved. Said that.

Critics have accused them of being too friendly with the Woodcock-regulated industry for years. Decades of tenure, leading the FDA’s pharmaceutical division, approved new, expensive medicines without sufficient evidence that they were effective or safe. Some, including Duchenne muscular dystrophy medicine and certain cancer treatments, have not yet been successful and have shown no clear clinical benefit.Another approval under Woodcock — for Dsuvia, a powerful fentanyl pill — elicited some anger and criticism from the FDA in Congress.External advisor to exacerbate the addiction crisis.

“It’s not as black and white as people want … these are difficult decisions and there’s really no right answer,” Woodcock told POLITICO in April. Even years after it hits the market, it shows no benefit for a particular tumor.

The White House did not respond to requests for comment on the story. An FDA spokesperson declined to comment.

Monday’s decision on Alzheimer’s disease, Known as aducanumab or aduhelm, the FDA has been thrown into new disagreements and secondary speculations from scientists, experts, and even Wall Street analysts. Three members of the FDA’s expert advisory board, who voted against drug approval in November, resigned in protest.

The agency’s longtime observer says it’s very unusual for Woodcock as acting commissioner. Keep public silence about Aducanumab’s decision.

Diana Zuckerman, director of the National Institute of Health, said: For years, “She has almost always been considered the most powerful person in the agency.”

Despite the blowback, there are few signs that it has affected Woodcock’s position in the West Wing. Biden has sought new investment in the development of treatments for Alzheimer’s disease and other illnesses, and two people familiar with his reaction say he is happy with the decision.

Biden is seeking $ 6.5 billion as part of its budget request for fiscal year 2022. Create a new research group Within the National Institutes of Health aimed at accelerating research on Alzheimer’s disease, diabetes and cancer.

Meanwhile, the White House has identified some viable alternatives to Woodcock for the FDA’s top jobs. The administration has scrutinized former Obama-era FDA official Michelle McMurray Heath for the role of commissioner, some people familiar with the process said.

However, McMurray Heath has been running the biotechnology innovation organization of the pharmaceutical industry group for the past year, which can make it difficult to sell within the Democratic Party, which advocates drug price crackdowns. In May, BIO criticized Biden’s decision to support the waiver of the Covid-19 vaccine and previously opposed the Trump administration’s efforts to curb drug prices.

Other former officials, including past commissioners, claim that Woodcock remains the best choice for the top role.

“If anything, it should show that she is willing to make unpopular and difficult decisions, even when they may counterattack her negatively. To me, it’s not a minus. It’s a big plus, “said a former senior health official, who said Woodcock was likely to leave the decision to the authorities’ drug reviewers. “I think most of what this tells you is that Janet is more focused on her job than winning the job.”

The lack of politically appointed commissioners can impede the FDA’s ability to launch new initiatives and make key policy decisions such as tobacco reform efforts. Authorities are also reducing the unprocessed portion of botanical tests and approvals for pharmaceuticals and medical devices.

Parliamentary pressure to find a permanent FDA chief continues to grow, and lawmakers from both parties are wondering what’s going on so long in a pandemic. Richard Burr of North Carolina, a top Republican member of the Senate Health Commission, complained this week that Biden hadn’t nominated an FDA candidate long ago.

“I have the utmost respect for Janet Woodcock. She leads the FDA well. I think she has all the qualifications she needs at the moment, but she’s good enough for that role. We need a confirmed person, “he said in a hearing on Tuesday. Other Biden candidates.

Barr and other Republicans said they supported Woodcock, a sign that she would be confirmed if nominated.However The administration is reluctant to host some Democrats who have been critical of Woodcock about her achievements in opioids, including Joe Manchin, West Virginia’s main swing vote.

Three other senators have also linked Woodcock to concerns about the opioid epidemic.

“I don’t trust her judgment. I don’t believe she’s the right person for the job. I disagree,” Senator Catherine Cortez Mast, a Democrat, told POLITICO.

Ed Markey, Massachusetts, is a spokesperson Senator Maggie Hassan said Democrats in New Hampshire “continue to believe that President Biden needs to propose an FDA commissioner to act independently of the industry he or she regulates.”

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

Senator Elizabeth Warren of Massachusetts and Senator Ron Weiden of Oregon are one of the most outspoken critics of the pharmaceutical industry in the Senate, as well as Woodcock’s support for a permanent operation of the FDA. I avoided that.

“I want to know who else is working on this,” Warren said of the candidate’s area of ​​running an agency. “I’m very concerned about the process used by the FDA since Monday’s approval for Alzheimer’s disease.” I’m doing it. “

Weiden, chair of the Finance Commission, recently There is a day to blow up the FDA’s decision-making, and on Thursday they said that the “important means” of his support for the final candidate was the need for such drugs to be effective and affordable. He said it was how to look.

In a brief interview on Thursday, Secretary of Health and Welfare Xavier Becerra did not promise to appoint a permanent FDA president by August, suggesting that it was primarily a White House decision. Woodcock could continue to act as a deputy member after August only if the administration also made an official nomination.

“That’s what I want to make sure I talk to the White House. [before answering]”I hope we have the opportunity to submit candidates to the Senate in the near future,” he said.

Besera added that Woodcock “was also useful as an act,” but it also seemed to be a distance from the authorities’ decision to approve a drug for Alzheimer’s disease.

“We rely on science to make this kind of call. The FDA has the right to a great deal of respect and independence in its actions, so we all know how the FDA operates. I would love to hear about science. ”

Controversial drug approval raises concerns about a shortage of permanent FDA chiefs

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