Controversial drug approval stokes concern about lack of a permanent FDA chief

“It is an unbelievable loss of confidence in transparency across the company, particularly the drug approval course of” and “an abject failure of management” on Woodcock’s half that the drug was accepted, stated a former senior FDA official.

Critics for years have accused Woodcock of being too pleasant with the business she regulates, and that underneath her decadeslong tenure heading FDA’s drug division the company accepted new, costly medicines with out sufficient proof they have been efficient or protected. A number of, together with a Duchenne muscular dystrophy drugs and sure most cancers remedies, have but to pan out and present clear medical profit. One other approval underneath Woodcock — for Dsuvia, a potent fentanyl tablet — has drawn the ire of some in Congress and criticism from FDAs exterior advisors for worsening the dependancy disaster.

“It is not as black and white as folks would really like … these are laborious selections and there isn’t any actually proper solutions,” Woodcock informed POLITICO in April amid the company’s final controversy over drug approvals, in that case involving most cancers medicines that didn’t present profit towards sure tumors after a number of years in the marketplace.

The White Home didn’t reply to a request for remark for this story. An FDA spokesperson declined to remark.

Monday’s determination on the Alzheimer’s drugs, often called aducanumab or Aduhelm, threw the FDA into a contemporary spherical of dissension and second-guessing from scientists, specialists and even Wall Road analysts. Three members of FDA’s skilled advisory panel — which voted towards approving the drug in November — resigned in protest.

Longtime observers of the company say it was extremely uncommon for Woodcock, as performing commissioner, to remain publicly silent about the aducanumab determination.

“It’s laborious to think about that she didn’t have a position on this,” stated Diana Zuckerman, president of the Nationwide Institute for Well being Analysis. All through the years, “she has been thought of the one who was essentially the most highly effective on the company, most of the time.”

But regardless of the blowback, there’s little signal it has affected Woodcock’s standing throughout the West Wing. Biden was happy with the choice, in line with two folks conversant in his response, which comes as he is pushed for contemporary funding in growing remedies for Alzheimer’s and different ailments.

Biden is in search of $6.5 billion as half of his fiscal 2022 finances request to create a new analysis group throughout the Nationwide Institutes of Well being geared toward accelerating work on Alzheimer’s, diabetes and most cancers.

In the meantime, the White Home has recognized few viable alternate options to Woodcock for the highest FDA job. The administration has vetted former Obama-era FDA official Michelle McMurry-Heath for the commissioner position, a number of folks conversant in the method stated.

However McMurry-Heath has now run the pharmaceutical business group Biotech Innovation Group for the previous yr, probably making her a tougher promote inside a Democratic Get together that is advocated cracking down on drug costs. BIO in Might criticized Biden’s determination to assist waiving patents on Covid-19 vaccines and beforehand opposed Trump administration efforts to rein in drug costs.

Different former officers, together with previous commissioners, insist that Woodcock remains to be one of the best choose for the highest position.

“If something, it ought to sign that she’s prepared to make what may very well be unpopular and laborious selections even once they would possibly negatively blow again on her. To me, that’s a huge plus, not a minus,” stated one former senior well being official, who famous that Woodcock seemingly left the choice as much as the company’s drug reviewers. “I believe largely what this tells you is Janet is extra centered on her job than successful a job.”

The lack of a politically appointed commissioner might hinder the FDA’s capability to launch new initiatives or make main coverage selections like tobacco reform efforts. The company can be whittling away a backlog of plant inspections and drug and medical machine approvals.

Congressional strain to search out a permanent FDA chief continues to mount, with lawmakers from each events questioning what’s taking so lengthy amid a world pandemic. The Senate well being committee’s high Republican, Richard Burr of North Carolina, complained this week that it was gone time for Biden to call an FDA nominee.

“I’ve the best respect for Janet Woodcock, she is main the FDA ably, and I believe she has all of the {qualifications} wanted for this second, however we’d like a absolutely confirmed particular person in that position,” he stated in a Tuesday listening to on different Biden nominees.

Burr and different Republicans have stated they’d again Woodcock, a signal that she can be confirmed if nominated. However the administration is loath to antagonize some Democrats who’ve been essential of Woodcock over her observe file on opioids, together with West Virginia’s key swing vote, Joe Manchin, whose state has been ravaged by the drug disaster.

Three different Democratic senators have additionally linked Woodcock to their issues about the opioid epidemic.

“I don’t belief her judgment, I don’t belief that she is the correct particular person for the job, and I’ll oppose it,” Sen. Catherine Cortez Masto (D-Nev.) informed POLITICO.

Ed Markey from Massachusetts stated he has “deep reservations,“ whereas a spokesperson for Sen. Maggie Hassan stated the New Hampshire Democrat “continues to consider that President Biden must put ahead an FDA commissioner who will act independently from the business that she or he regulates.”

“They don’t want Democrats to vote, they simply want Democrats to not be actually offended,” Zuckerman stated of the administration.

Sens. Elizabeth Warren of Massachusetts and Ron Wyden of Oregon — who rank among the many Senate’s most outspoken drug business critics — equally shied away from voicing assist for Woodcock to run the FDA on a permanent foundation.

“I wish to see who else is up on this,” Warren stated of the sector of potential candidates to run the company, including that she got here away from Monday’s Alzheimer’s approval “very involved about the method that the FDA has used.”

Wyden, who chairs the Finance Committee, has spent latest days blasting the FDA’s decisionmaking, and on Thursday stated a “essential measure” of his assist for an eventual nominee shall be how they view the necessity for such medication to be each efficient and reasonably priced.

In a temporary interview on Thursday, Biden well being secretary Xavier Becerra wouldn’t decide to nominating a permanent FDA head earlier than August, and instructed it’s largely a White Home determination. Woodcock might solely stay performing commissioner past August if the administration has additionally made an official nomination.

“That is one thing I’d wish to be sure that to debate with the White Home [before answering],” he stated. “We hope at some point we’ll have the chance to current the nominee to the Senate.”

Becerra added that Woodcock has “served properly as performing,” but in addition appeared to distance himself from the company’s determination to approve the Alzheimer’s drug.

“We depend on the science after we make these varieties of calls, and since the FDA is entitled to a nice deal of deference and independence in the way in which that it acts, I believe all of us wish to hear simply how the FDA operates based mostly on the science,” he stated.

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