Two high-ranking Congressional Democrats are pushing Biogen to answer for a slew of concerns over its hotly contested Alzheimer’s treatment Aduhelm, including reports of the drugmaker’s cozy relationship with U.S. regulators and the drug’s lofty $56,000 annual list price.
As part of the House Committee on Oversight and Reform probe into Aduhelm, Chairwoman Rep. Carolyn Maloney, D-New York, and Rep. Frank Pallone Jr., D-New Jersey, chairman of the House Committee on Energy and Commerce, issued a letter to Biogen on Monday seeking additional documents on pricing and more.
The requests come just days after the FDA’s own acting chief, Janet Woodcock, M.D., took the unusual step of asking the Office of Inspector General to investigate the regulator’s decision to award Aduhelm the go-ahead, an approval that has roiled lawmakers, physicians and others for weeks.
In their Monday letter, the lawmakers told Biogen that they’re concerned about reports of the company’s “atypical” approval process and a secret campaign, dubbed “Project Onyx.” The FDA eventually awarded Aduhelm and accelerated approval on its ability to remove amyloid plaque from the brain, rather than actually slowing someone’s cognitive decline.
The company’s dealings, first reported by Stat News, dated back to as early as 2019 and included off-the-books meetings with FDA leadership that eventually led to the once-failed Alzheimer’s drug crossing the agency’s finish line.
The committee asked Biogen to cough up documents and communications involving the project and Aduhelm’s regulatory review process, as well as “dates, times, locations, attendees, and any notes or minutes taken” from formal and informal meetings with the FDA.
As part of the probe, the committee is seeking evidence of Aduhelm’s clinical benefits, including documents that support the removal of amyloid plaque as a method to eventually treat cognitive decline, the lawmakers wrote. Biogen should also detail the plans for its required phase 4 confirmatory trial, including an estimated timeline.
The investigation is also taking aim at the Cambridge-based drugmaker’s reasoning for Aduhelm’s $56,000 per year list price, well above what analysts and advisory groups had predicted, even though the drug showed murky benefits in clinical trials.
Biogen should send a detailed breakdown of the cost it incurred to develop Aduhelm, as well as all communications regarding “pricing, manufacturing costs, commercialization, or potential marketing strategies,'' the letter said.
Maloney and Palone said Biogen has until July 26 to produce the requested materials. Biogen told Fierce Pharma that it will cooperate with the committee's inquiry.
The House Oversight Committee’s investigation is just one piece to what has been a whirlwind fallout for Biogen and the FDA’s top brass over Aduhelm’s approval. Consumer group Public Citizen on Tuesday called on Christi Grimm, principal deputy inspector general of HHS, to investigate Woodcock and the role the interim commissioner played in the agency's decision. The group claimed public trust in the FDA “has been severely damaged” as a result.
Woodcock has repeatedly defended the FDA's communications with the company and said on Friday that she has “tremendous confidence” in the agency’s leadership.