FDA Pulls Back Curtain On Alzheimer’s Drug Approval Process In Wake Of Uproar
Details on internal meetings are revealed in documents released by the Food and Drug Administration Tuesday. The agency is trying to calm criticism of its accelerated review of the contentious Alzheimer's disease treatment, Adulhelm, but the new information may set off a fresh wave of concerns, news outlets report.
The Washington Post:
FDA Releases Fresh Details On Internal Debate Over Controversial Alzheimer’s Drug
The Food and Drug Administration on Tuesday released fresh details on why it approved a controversial Alzheimer’s drug in hopes of quelling a fierce debate over whether the agency should have cleared the costly treatment. But the new information, included in interviews with agency officials and 83 pages of internal documents, might not quiet a furor over the drug Aduhelm that has drawn in Alzheimer’s doctors and patients, members of Congress, Medicare officials, and the agency itself. (McGinley, 6/22)
Stat:
Documents Reveal The FDA’s Unprecedented Path To Approving Aduhelm
Chastened after a decisively negative review from outside advisers, the Food and Drug Administration convened a series of internal meetings in March and April where top officials hammered out a plan to approve Biogen’s Alzheimer’s drug, Aduhelm. The meetings were revealed in a series of documents released Tuesday by the FDA to explain its decision to use a truncated pathway, called accelerated approval, to approve Aduhelm. (Herper, Garde and Feuerstein, 6/22)
Bloomberg:
Alzheimer’s Therapy Sparked Behind-Scenes FDA Clash On Approval
Statisticians at the Food and Drug Administration who had a thorough look at the clinical-trial data didn’t support approval of Biogen Inc.’s Alzheimer’s therapy, internal documents released by the agency show. The documents released on Tuesday show how top FDA officials weighed the concerns of their staff against the need of patients suffering from a serious fatal disease with no treatments that can halt its progression. (Edney and Langreth, 6/22)
Politico:
FDA Approved Alzheimer's Drug Over Internal Objections
Statisticians at the Food and Drug Administration opposed this month's agency approval of a controversial Alzheimer’s drug, saying there was not enough evidence to prove the treatment works. The objections by Office of Biostatistics Director Sylva Collins, reviewer Tristan Massie and other agency statisticians are detailed in documents that the FDA released Tuesday. The criticisms align with those from a panel of external FDA advisers who voted last fall that there was not enough evidence to prove the drug from Biogen, known as Aduhelm, is effective. (Lim and Morello, 6/22)
The Wall Street Journal:
FDA Approved Biogen Alzheimer’s Drug Despite Some Staff Concerns
The U.S. Food and Drug Administration approved the first new Alzheimer’s drug in decades over the objection of agency statisticians who said there was insufficient evidence to support approval, according to newly released internal memos. In the internal memos released Tuesday, FDA officials discussed whether to approve the drug from Biogen Inc. over objections from the agency’s drug statistics office, which said that clinical trial data fell short of the proof typically required to put a new product on the market. (Walker and Burton, 6/22)
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New Orleans Times-Picayune:
Despite Controversial Approval, Arrival Of This New Alzheimer's Drug Is Bringing 'Hope' To Louisiana
Dr. Demetrius Maraganore, chair of the neurology department at Tulane University School of Medicine, said that since the approval, "the phone is ringing off the hook" with people who have questions about the drug and whether it might help their loved one. “Until June 7, we really had no tools in our toolbox for Alzheimer's disease,” said Maraganore. “We had some Band-Aids, some medicines that improved symptoms sometimes, a little bit. For the first time, we've got a toolbox and now it’s open.” (Woodruff, 6/22)
WJCT 89.9 FM Jacksonville:
DeSantis Touts Additional $12 Million In Budget For Alzheimer’s
Gov. Ron DeSantis held a press conference Monday to discuss the state’s increased budget for Alzheimer’s research and care in Jacksonville. Florida will allocate $51 million toward dealing with Alzheimer’s disease during the state’s 2021-22 fiscal year, an increase of $12 million. The money will fund the state’s Alzheimer’s Disease Initiative, which helps provide care and equipment for those dealing with the disease. (Wood, 6/22)
