Two powerful congressional committees investigating the controversial federal approval of Biogen’s Alzheimer’s drug Aduhelm requested extensive information and documents from the Food and Drug Administration on Thursday, making it clear that committee leaders are concerned by unusual actions the agency has taken over the course of the year Assessment and approval of the drug.
“We are concerned about apparent anomalies in the FDA’s processes related to the review of Aduhelm,” said committee chairs in a 13-page letter requesting a range of documents and answers to questions.
“The FDA granted expedited approval to the drug despite concerns raised by experts – including the agency’s own staff,” and members of its independent advisory committee, the letter said.
“We are also concerned about reports of unusual coordination between the FDA and Biogen during the drug’s approval process,” the committee added.
The letter – addressed to the Acting Commissioner of the FDA, Dr. Janet Woodcock and signed by Rep. Carolyn Maloney, Chair of the House Oversight and Reform Committee, and Frank Pallone, Chair of the House Energy and Commerce Committee – asked for information on virtually every step of the FDA’s handling of Aduhelm, the brand name for aducanumab.
Citing details first reported in an investigation to the New York Times in July, the letter notes that two months before the drug was given the go-ahead in June, a council of senior FDA officials “concluded” that another clinical study was needed before the drug was approved “. Approval could result in millions of patients taking aducanumab with no indication that they could actually get any benefit or, worse, cause harm. “
The approval of Aduhelm – a treatment that requires monthly intravenous fluids priced at $ 56,000 a year for Biogen – received a firestorm of criticism from many Alzheimer’s experts and other scientists.
While some Alzheimer’s experts backed the approval because there are so few therapies for the devastating disease, many are concerned that the evidence is inconclusive that the drug may be of any benefit. There is also concern that the drug may cause brain swelling or hemorrhage.
This is a developing story.