FDA Calls for Investigation of the Approval of Biogen’s Alzheimer’s Drug amid Backlash

The acting chief of the Food and Drug Administration has asked for an inquiry of the circumstances leading up to Biogen's approval of aducanumab also known as Aduhelm, a brain plaque-clearing dementia medication.

FDA Acting Commissioner Janet Woodcock, M.D., urged the Office of the Inspector General to promptly evaluate the agency's activities prior to its contentious decision in a Friday letter, recognizing the "significant attention and controversy" surrounding the drug's approval last month. The inspector general of the Department of Health and Human Services, which supervises the FDA and other federal health agencies, received Woodcock's request.

Given the ongoing interest and questions, today I requested that @OIGatHHS conduct an independent review and assessment of interactions between representatives of Biogen and FDA during the process that led to the approval of Aduhelm. pic.twitter.com/iWJNxdZ5Cs
— Dr. Janet Woodcock (@DrWoodcockFDA) July 9, 2021

FDA head concerned over approved Alzheimer's drug

Medical experts, consumer advocates, and members of Congress have all called for an investigation into the approval. Two congressional committees have begun their investigation. Woodcock was concerned that allegations of unofficial communication between Biogen and FDA reviewers outside of the formal drug trial review process would erode the public's trust in the FDA, NBC News reported.

Last month, the health news site Stat revealed numerous new details concerning Aduhelm manufacturer Biogen's extremely tight engagement with the FDA's drug review staff. An unrecorded meeting between a top Biogen executive and the FDA's chief reviewer for Alzheimer's drugs was disclosed by the site in May 2019.

Biogen called the meeting after two trials were halted because the drug didn't appear to delay the illness as expected. Biogen and the FDA collaborated on reanalyzing the data and concluded that the medication could work. The Alzheimer's drug was conditionally approved two years later, based on the fact that it decreased the formation of sticky plaque in the brain, which is considered to have a role in Alzheimer's disease.

The FDA authorized aducanumab, now known as Aduhelm, in June, sending Biogen's stock to a six-year high and igniting a surge of enthusiasm among dementia caregivers and families eager for new treatment choices for their loved ones. However, it didn't stop the criticism of Aduhelm's clinical development procedure, which has long been a source of controversy, as per MarketWatch via MSN.

FDA committee members quit amid outrage with Alzheimer's drug approval

It was uncertain if the medication would be approved as the FDA decision date approached. Based on the clinical-trial data made public as part of Biogen's application, an independent advisory group generally ruled against the efficacy of aducanumab back in November.

In response to the approval, which was announced on June 7, many members of the committee resigned. One of the most recent criticisms is that the drug was licensed to treat a broad spectrum of Alzheimer's disease patients. Biogen's proposal to restrict the indication to just cover patients with mild cognitive impairment or mild dementia stage of illness was granted by the FDA earlier this week.

The FDA approached the firm first about reducing the label, and the phrase was approved. Despite the revision, the FDA said that "some patients may benefit from continued treatment" if they acquire more severe Alzheimer's disease.

A top FDA official told reporters when the Alzheimer's drug was first approved that it was relevant to all phases of the disease. The FDA's approval last month sparked outrage over Aduhelm's $56,000 annual price tag and dubious advantages.

Per SFGate, Harvard researcher Dr. Aaron Kesselheim called the authorization the "worst drug approval decision in recent US history." Kesselheim tweeted on Thursday that the adjustment was "welcome," but that the FDA and Biogen should do a lot more to address misconceptions regarding this medication.