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An FDA sign is seen outside the headquarters on July 20, 2020 in White Oak, Maryland.
Sarah Selbiger | Getty Images
CNBC has learned that a third member of the FDA’s main advisory committee has resigned over the agency’s controversial decision to approve Biogen’s new Alzheimer’s drug, Aduhelm.
Dr. Aaron Kesselheim, professor of medicine at Harvard Medical School, said the agency’s decision on Biogen “may have been the worst drug approval decision in recent U.S. history,” according to his resignation letter obtained by CNBC.
“At the last minute, the agency shifted its review to the accelerated approval pathway based on the debatable premise that the drug’s effect on amyloid in the brain is likely to help Alzheimer’s patients,” he wrote in his resignation from the FDA’s Central and Peripheral Nervous System. Advisory Committee.
He wrote that it was “obvious” to him that the agency “is not currently able to adequately integrate the committee’s scientific recommendations into its approval decisions.”
“This will undermine the care of these patients, the public’s trust in the Food and Drug Administration, the pursuit of beneficial treatment innovation, and the affordability of the health care system,” he said.
Shares of Biogen rose 38% Monday after the Food and Drug Administration approved the biotech company’s drug, the first drug approved by US regulators to slow cognitive decline in people with Alzheimer’s disease and the first new drug for the disease in nearly two decades.
Biogen targets a “sticky” compound in the brain known as beta-amyloid, which scientists speculate plays a role in the devastating disease.
The U.S. Food and Drug Administration approved the drug under a program called Expedited Approval, which is typically used for cancer drugs, and it predicts that the drug will slow cognitive decline in Alzheimer’s patients. The agency granted approval on the condition that Biogen conduct another clinical trial.
The agency’s decision was a departure from the advice of its independent team of outside experts, who unexpectedly declined to approve the drug last fall, citing unconvincing data. At the time, the committee also criticized agency staff for what it called an overly positive review of the data.
At least two FDA panel members have resigned as a result of the agency’s decision on the drug. Mayo Clinic neurologist Dr. David Knopman and University of Washington neurologist Dr. Joel Perlmutter have also submitted letters of resignation.
“I was very disappointed in the way the FDA handled the advisory committee’s contributions,” Dr. Knopman told Reuters. “I don’t want to be in a situation like this again.”
-Reuters contributed to this report.
This is an evolving story. . Please check back for updates
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