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

United States News News

Controversial drug approval stokes concern about lack of a permanent FDA chief
United States Latest News,United States Headlines
  • 📰 politico
  • ⏱ Reading Time:
  • 40 sec. here
  • 2 min. at publisher
  • 📊 Quality Score:
  • News: 19%
  • Publisher: 59%

The FDA’s approval of a controversial new Alzheimer’s drug this week has hardened opposition to acting commissioner Janet Woodcock, who remains President Joe Biden’s apparent favorite to be the agency’s permanent leader

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.to stay publicly silent about the aducanumab decision.

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. 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.

Burr and other Republicans have said they would back Woodcock, a sign that she would be confirmed if nominated. But the “They don’t need Democrats to vote, they just need Democrats not to be really angry,” Zuckerman said of the administration.

We have summarized this news so that you can read it quickly. If you are interested in the news, you can read the full text here. Read more:

politico /  🏆 381. in US

United States Latest News, United States Headlines

Similar News:You can also read news stories similar to this one that we have collected from other news sources.

Two members of U.S. FDA advisory panel resign over Alzheimer's drug approvalTwo members of U.S. FDA advisory panel resign over Alzheimer's drug approvalTwo members of a panel of outside advisors to the U.S. Food and Drug Administration have resigned in protest at the agency's decision to approve Biogen Inc's (BIIB.O) Aduhelm for treatment of Alzheimer's disease despite the committee’s recommendation against doing so.
Read more »

Two members of FDA panel resign in protest over Alzheimer's drug approvalTwo members of FDA panel resign in protest over Alzheimer's drug approvalThe 11-member committee voted nearly unanimously in November that Biogen's drug should not be approved, citing inconclusive evidence.
Read more »

Third member of prestigious FDA panel resigns over approval of Biogen's Alzheimer's drugThird member of prestigious FDA panel resigns over approval of Biogen's Alzheimer's drugA third member of a key FDA panel has resigned over the agency's controversial decision to approve Biogen's new Alzheimer's drug, Aduhelm, CNBC has learned.
Read more »

Two doctors have resigned from a prestigious panel after FDA approved a controversial Alzheimer's drugBusiness Insider tells the global tech, finance, markets, media, healthcare, and strategy stories you want to know.
Read more »

Third member of FDA advisory panel resigns over Alzheimer's drug approvalThird member of FDA advisory panel resigns over Alzheimer's drug approvalA third member of a panel of outside advisers to the U.S. FDA has resigned in protest over the agency's decision to approve Biogen Inc's Alzheimer's disease treatment despite the committee's recommendation against doing so.
Read more »

Moderna Asks FDA For Emergency Approval Of Its Covid-19 Vaccine In Teens Aged 12-17Moderna Asks FDA For Emergency Approval Of Its Covid-19 Vaccine In Teens Aged 12-17Moderna announced that it has filed a request with the FDA for Emergency Use Authorization of its Covid-19 vaccine in teens aged 12-17
Read more »



Render Time: 2025-04-07 17:42:46