Two House committees sent a 13-page letter to acting US Food and Drug Administration Commissioner Janet Woodcock on Wednesday (September 1) as part of an investigation into the recent accelerated approval of a controversial drug for Alzheimer’s disease.
The letter—signed by representatives Carolyn B. Maloney (D-NY), chairwoman of the Oversight and Reform Committee, and Frank Pallone Jr. (D-NJ), chairman of the Energy and Commerce Committee—requested information about who was involved in the approval of the Biogen-produced drug and how the decision was made.
The drug—called Aduhelm—received accelerated approval from the agency on June 7, making it the first FDA-approved drug for Alzheimer’s in nearly 20 years. Aduhelm is supposed to remove amyloid-β plaques that accumulate in the brain, although some experts say plaque removal doesn’t slow disease progression and may carry the risk of causing bleeding or swelling in the brain, according to The New York Times.
Two late-stage clinical trials on Aduhelm were stopped in 2019 due to a lack of clear evidence of the drug’s efficacy, although Biogen, the company behind the drug, later said a reanalysis of the data showed it had benefits. A panel of outside experts recommended against approving the drug, and according to the Times, a former senior medical director at Biogen also opposed the approval.
“We are concerned by apparent anomalies in FDA’s processes surrounding its review of Aduhelm,” says the letter, according to STAT. “We are also concerned by reports of unusual coordination between FDA and Biogen throughout the drug’s approval process.” The same committees had requested documents from Biogen in July pertaining to its assessments of Aduhelm and the regulatory process.
According to the Times, the letter requests information about undocumented meetings between FDA officials and Biogen representatives, and asks whether agency officials collaborated with Biogen on projects or proposals while the drug was awaiting approval.
Despite the approval, the Times reports that several major medical centers in the country are refusing to offer Aduhelm, including Providence, Mount Sinai Health System, and the Cleveland Clinic. The treatment costs about $56,000 a year and requires monthly intravenous infusions.
In response to the letter, Biogen said in a statement on Thursday, “We are continuing to cooperate with the committees’ investigation and to produce documents in response to the committees’ requests,” according to the Times.