July 10 (UPI) — The acting commissioner of the Food and Drug Administration on Friday asked the Department of Health and Human Services’ inspector general to review the agency’s approval of a new Alzheimer’s drug.
The FDA gave the green light for a new drug marketed under the brand name Aduhelm in June. Manufactured by drugmaker Biogen, it’s the first to be approved for the debilitating form of dementia since 2003.
But some experts — including the FDA’s own Peripheral and Central Nervous System Drugs Advisory Committee, which rejected the drug last November — argued that there is insufficient evidence that it helps patients with the disease.
Dr. Janet Woodcock, acting FDA commissioner, sent a letter to the HHS Office of the Inspector General, asking for an independent review of the interactions between Biogen representatives and the FDA, citing “significant attention and controversy” surrounding the approval process.
“There continue to be concerns raised … regarding contacts between representatives from Biogen and FDA during the review process, including some that may have occurred outside of the formal correspondence process,” she wrote.
“To the extent these concerns could undermine the public’s confidence in FDA’s decision, I believe that it is critical that the events at issue be reviewed by an independent body such as the Office of the Inspector General.”
On Thursday, Biogen revised its label for the drug, recommending it only be used in patients with mild cognitive impairment or dementia.
The changes to the product label, which spells out proper use and safety information for the drug, include text specifying that treatment with aducanumab “should be initiated in patients with or mild dementia stage of disease, the population in which treatment was initiated in clinical trials,” the company said.
