Two powerful congressional committees investigating the controversial federal approval of Biogen’s Alzheimer’s drug, Aduhelm, demanded extensive information and documents from the Food and Drug Administration on Thursday, making it clear that the committees’ leaders are troubled by unusual actions the agency took in the course of evaluating and approving the drug.
“We are concerned by apparent anomalies in F.D.A.’s processes surrounding its review of Aduhelm,” the committee chairs said in a 13-page letter asking for a raft of documentation and answers to questions.
“F.D.A. granted accelerated approval for 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 by reports of unusual coordination between F.D.A. and Biogen throughout the drug’s approval process,” the committee added.
The letter — addressed to the F.D.A.’s acting commissioner, Dr. Janet Woodcock and signed by Representative Carolyn Maloney, chair of the House Committee on Oversight and Reform, and Representative Frank Pallone, chair of the House Energy and Commerce Committee — asks for information about virtually every step of the F.D.A.’s handling of Aduhelm, the brand name for aducanumab.
Citing details first reported in a New York Times investigation in July, the letter notes that two months before the drug was greenlighted in June, a council of senior F.D.A. officials “‘concluded that another clinical trial was necessary before approving the drug,’ with one member noting that approval could ‘result in millions of patients taking aducanumab without any indication of actually receiving any benefit, or worse, cause harm.’”
The approval of Aduhelm — a treatment requiring monthly intravenous infusions that Biogen has priced at $56,000 a year — has been met with a firestorm of criticism from many Alzheimer’s experts and other scientists.
While some Alzheimer’s experts did support the approval, given that there are so few therapies available for the devastating condition, many are concerned that the evidence does not convincingly show the drug can provide any benefit. There is also concern that the medication can cause brain swelling or brain bleeding.
This is a developing story.
Source: Read Full Article