A sign for the Food and Drug Administration will be seen outside headquarters on July 20, 2020 in White Oak, Maryland.
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A third member of a central advisory panel for the Food and Drug Administration has been withdrawn due to the agency’s controversial decision to approve Biogen̵
Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, said the agency’s decision on Biogen “was probably the worst drug approval decision in recent U.S. history,” according to his resignation from CNBC.
“At the last minute, the agency shifted its review to the accelerated approval pathway based on the questionable assumption that the drug’s effect on brain amyloid would likely help patients with Alzheimer’s disease,” he wrote as he resigned from the FDA’s peripheral and central nervous system. Advisory Committee.
He wrote that it was “clear” to him that the Agency was not “currently able to adequately integrate the Committee’s scientific recommendations into its approval decisions.”
“This will undermine the care of these patients, public confidence in the FDA, the pursuit of useful therapeutic innovation, and the affordability of healthcare,” he said.
Biogen’s share rose sharply by 38% on Monday after the FDA approved the drug for biotechnology, the first drug cleared by U.S. regulators to slow cognitive decline in people living with Alzheimer’s and the first new drug for the disease in almost two decades.
The biogenic drug is targeted at a “sticky” compound in the brain known as beta-amyloid, which researchers expect to play a role in the devastating disease.
The FDA approved the drug under a program called accelerated approval, which is commonly used for cancer drugs and expects the drug to slow the cognitive decline in Alzheimer’s patients. The Agency approved on the condition that Biogen conduct another clinical trial.
The agency’s decision was a departure from the advice of its independent panel of external experts, who unexpectedly refused to approve the drug last fall and did not cite convincing data. At the time, the panel also criticized the agency’s staff for what it called an overly positive review of the data.
At least two other members of the FDA panel have withdrawn as a result of the agency’s decision on the drug. Mayo Clinic neurologist Dr. David Knopman and Washington University neurologist Dr. Joel Perlmutter has also submitted resignation letters.
“I was very disappointed with the way the Advisory Committee’s input was handled by the FDA,” said Dr. Knopman to Reuters. “I do not want to be put in a position like this again.”
– Reuters contributed to this report.
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