Food and Drug Administration acting Commissioner Janet Woodcock announced Friday that she has requested a federal investigation into the agency’s meetings with the maker of the controversial Alzheimer’s treatment Aduhelm in the lead-up to approval.
FDA NARROWS ELIGIBILITY FOR CONTROVERSIAL $56,000 ALZHEIMER’S TREATMENT
“Given the ongoing interest and questions, today I requested that [the Department of Health and Human Services Office of Inspector General] conduct an independent review and assessment of interactions between representatives of Biogen and FDA during the process that led to the approval of Aduhelm,” said Woodcock.
Woodcock’s decision to request the investigation into her own agency’s dealings with the manufacturer is a surprise, given that Woodcock has stood by the decision to grant accelerated approval for the monthly intravenous treatment. She said in her letter to the HHS OIG that she has “tremendous confidence in the integrity of the staff and leadership of the Center for Drug Evaluation and Research … and their commitment to unbiased and science-based decision-making.”
The investigation, if the HHS OIG agrees to move forward, will be centered on interactions between a Biogen official, Alfred Sandrock Jr., and Billy Dunn, the head of the FDA’s Office of Neuroscience, after medical news outlet Stat reported on an under-the-table meeting between them in May 2019 in which they discussed pathways to approval for the treatment.
“There continue to be concerns raised, however, regarding contacts between representatives from Biogen and FDA during the review process, including some that may have occurred outside of the form correspondence process,” Woodcock said.
The agency made a controversial decision last month to approve the treatment despite objections from the panel of neurologists tasked with reviewing the evidence to back up the company’s application for approval. The panel was nearly unanimous — one member abstained from voting on approval — in their opposition to the treatment, citing a lack of evidence that it would actually help slow cognitive decline in people in the early stages of the degenerative disease.
Three neuroscientists resigned from their positions on the panel in protest soon after the agency issued its approval.
“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 … in order to determine whether any interactions that occurred between Biogen and FDA review staff were inconsistent with FDA policies and procedures,” Woodcock said in the letter to the OIG.
The treatment was granted accelerated approval on June 7 with the guidance that all Alzheimer’s patients were eligible to receive the treatment. Biogen drew criticism from advocacy groups such as the Alzheimer’s Association and Public Citizen after it announced the treatment’s list price would be about $56,000 for 12 monthly injections, potentially causing federal spending on Medicare to swell by $57 billion in a single year. In addition, out-of-pocket costs for Alzheimer’s patients undergoing imaging and other ancillary services could reach $11,500.
The FDA tried to quell objections to blanket approval for all Alzheimer’s patients, which would have financially strained the Medicare program, when it narrowed eligibility on Thursday to just those in the early stages of the disease.
Democratic Rep. Frank Pallone of New Jersey, chairman of the Committee on Energy and Commerce, and Democratic Rep. Carolyn Maloney of New York, the chairwoman of the Committee on Oversight and Reform launched an investigation into Biogen’s pricing decisions last month, arguing that a treatment that lacks strong evidence of efficacy should not be priced at such prohibitive rates.
CLICK HERE TO READ MORE FROM THE WASHINGTON EXAMINER
“We are pleased that following the announcement of our investigation into Aduhelm’s approval process, Acting Commissioner Woodcock has asked the OIG to review this matter,” they said in a joint statement on Friday. “We continue to have concerns about the approval process for Aduhelm, how Biogen set its price, and the implications for seniors, providers, and taxpayers. An OIG review will complement our Committees’ robust investigation of this matter.”
