Published 3 years ago

Resignations Roil FDA Evaluation Process

Summary by Political Wire

Reuters: “A third member of a panel of outside advisers to the U.S. Food and Drug Administration 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.”“The 11-member committee voted nearly unanimously in November that Biogen’s drug should not be approved, citing inconclusive evidence that the drug was effective.”

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Reuters

Third member of U.S. FDA advisory panel resigns over Alzheimer’s drug approval

A third member of a panel of outside advisers to the U.S. Food and Drug Administration has resigned in protest over the agency's decision to approve Biogen Inc's (BIIB.O) Alzheimer's disease treatment despite the committee's recommendation against doing so.

3 years ago·United Kingdom

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The Washington Post

The debate over the FDA-approved Alzheimer’s drug showcases our system’s skewed priorities

In the U.S. health-care system, patients’ interests chronically come behind the interests of big business.

3 years ago

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Washington Examiner

Three members of FDA drug review panel resign over approval of $56K Alzheimer’s drug

FILE - In this Aug. 14, 2018 file photo, Dr. William Burke goes over a PET brain scan at Banner Alzheimers Institute in Phoenix. The drug company Biogen Inc. says it will seek federal approval for a medicine to treat early Alzheimer's disease, a landmark step toward finding a treatment that can alter the course of the most common form of dementia.The announcement Tuesday, Oct. 22, 2019, is a surprise because the company earlier this year stopped…

3 years ago·Washington, United States

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National Post

Three FDA advisers have resigned over its approval of new Alzheimer’s drug

"I am extraordinarily disappointed that our unbiased advisory committee review was not valued"

3 years ago·Canada

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npr

3 Experts Have Resigned From An FDA Committee Over Alzheimer's Drug Approval

In his resignation letter, Dr. Aaron Kesselheim calls it "probably the worst drug approval decision in recent U.S. history." An FDA official says the agency found the benefits outweighed the risks.(Image credit: Scott Eisen/AP Images for AIDS Healthcare Foundation)

3 years ago·Washington, United States

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FijiTimes

Analysis: U.S. FDA faces mounting criticism over Alzheimer’s drug approval

In approving the first new Alzheimer’s drug in nearly 20 years, the U.S. Food and Drug Administration is taking its biggest risk yet with a strategy that allows new therapies onto the market without strong evidence that they work, regulatory and scientific experts say.The Biogen Inc (BIIB.O) drug, Aduhelm, was authorized based on evidence that it can reduce brain plaques, a likely contributor to Alzheimer’s, rather than proof that it slows progr…

3 years ago·Fiji

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