First Biogen, now the FDA: Congressional Democrats request agency records over Aduhelm’s approval

By | September 3, 2021

Months after two high-ranking Democrats demanded Biogen answer for concerns shrouding its controversial Alzheimer’s drug Aduhelm, the lawmakers are now turning their aim toward the FDA.

In a letter sent to the agency’s interim commissioner Janet Woodcock, M.D., the chairs of two leading House committees—Rep. Carolyn Maloney, D-New York, and Rep. Frank Pallone Jr., D-New Jersey—demanded the FDA produce additional data and documentation supporting its accelerated approval for the drug.

The request comes after the House Committee on Oversight and Reform in late June opened an investigation into the hotly debated Alzheimer’s treatment, which received a historic FDA nod earlier that month despite murky clinical benefits and a resounding thumbs down from the agency’s own independent advisors. 

The lawmakers sent a similar request to Biogen in July, seeking additional background over the company’s dealings with regulators and its decision to price Audhelm at $ 56,000 per year. Many fear the list price could exacerbate Medicare spending given a majority of the 6 million Americans living with the disease are thought to be on the government-run insurance program. 

RELATED: Biogen’s Aduhelm probe in Congress escalates as lawmakers ask for info on FDA meetings, pricing tactics

In their letter to the FDA, lawmakers said they were “concerned by apparent anomalies in FDA’s processes surrounding its review of Aduhelm,” as well as the “unusual coordination” between the agency and Biogen. 

The lawmakers cite a June report from Stat News that found Biogen’s dealings with the FDA dated back to 2019 and included off-the-books meetings with agency leadership. Maloney and Pallone also disclosed a previously unreported meeting between FDA staff and its committees on July 23. 

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The committees want the agency to present additional data supporting their theory that removing amyloid beta plaque, a defining characteristic of Alzheimer’s in a patient’s brain, is “reasonably likely” to provide clinical benefit. Many experts have debated that idea, as the letter points out.

Further, the lawmakers are pressing the agency to provide details on all formal and informal interactions with Biogen, as well as its reasoning for awarding Aduhelm a broad indication that went well beyond the patients studied in its clinical trials. 

The FDA first granted Aduhelm a wide-ranging label that essentially gave Biogen free rein over the millions of Alzheimer’s patients living in the U.S. Facing backlash, the agency swiftly narrowed Aduhelm’s label to people with milder forms of the disease. Maloney and Pallone asked the FDA to disclose why it revised Aduehlm’s prescribing information. 

RELATED: Biogen’s Aduhelm label far exceeds clinical trial population, study says. That could bring real-world surprises

The committees also asked for additional background into Biogen’s phase 4 confirmatory trial, including its projected design and timeline. The FDA has until Sept. 16 to produce the materials, the letter said. A spokesperson for the agency wasn’t immediately available for comment. 

The probe is being conducted alongside another investigation from the Department of Health and Human Services’ Office of Inspector General, which is investigating the agency’s approval process for Aduhelm. That investigation came after a request from Woodcock herself in July. 

It also comes at a precarious time for the FDA, which hasn’t had a permanent commissioner since President Joe Biden took office in January. Woodcock, once considered a front runner for the top job, has since been ruled out, according to multiple reports

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The FDA veteran has faced an uphill battle with senators who serve as key swing votes for the president’s eventual nominee, notably Sen. Joe Manchin, D-West Virginia. That’s partially because of the agency’s speedy Audhelm approval under Woodcock’s watch, Bloomberg reported in August.

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