Instant Report
FDF

Date: 09-Jul-2021

Lawmaker Blasts FDA Over Biogens Undue Influence In Aduhelm Review Calls For HHS Probe

Biogen isn't alone in facing scrutiny from Capitol Hill following its regulatory win for Alzheimer’s treatment Aduhelm. As more details surrounding the drug's approval come to light, prominent Democratic lawmakers have set their sights on another target—the FDA itself.

 

Less than two weeks after the House Committee on Oversight and Reform said it would investigate the hotly debated FDA approval and pricing for Biogen’s Aduhelm, Rep. Katie Porter, D-California, is calling on HHS to evaluate the FDA’s dealings with the drugmaker leading up to Aduhelm’s green light.

Porter, well known for her sharp questioning of powerful executives, urged HHS in a letter dated Tuesday to conduct “a full review” of the agency’s communications with pharma executives, lobbyists and other stakeholders. She hopes the agency will establish new policies that prevent “fraud, waste, and abuse.”  

 

The concern centers on a recent report from Stat News that found Biogen executives had met with FDA officials, specifically Billy Dunn, M.D., director of the FDA’s neuroscience unit, as early as 2019 to discuss a regulatory pathway for Aduhelm. Those meets occurred even when it seemed like the drug was dead in the water. 

RELATED: Congressional Democrats launch probe into Biogen's Aduhelm FDA approval, citing 'serious concerns'

In 2020, the company lost a legal battle over its blockbuster multiple sclerosis drug Tecfidera and was facing a patent cliff for its other major drug, Tysabri, Porter noted, arguing that the Aduhelm revival campaign was a critical effort at Biogen.

The Cambridge-based drugmaker’s stock dropped 30% when it initially disclosed the failed Aduhelm trials in March 2019, resulting in $16 billion worth of lost market value. 

The effort to revive Aduhelm, dubbed “Project Onyx,” led to “off the books” meetings between the FDA and Biogen and, eventually, a suggestion from the agency that the drugmaker file for an accelerated approval, according the Stat report. The discussions potentially violated the FDA’s protocols, Porter wrote. 

For too long, outside groups have had “inappropriate access” to officials within HHS, she wrote in Tuesday's letter. Patients deserve to know that drug approvals were made by independent scientists, not companies with “clear financial motivations for pursuing approval for inadequate treatments,” Porter wrote. 

Porter’s letter joins the escalating chorus of backlash, both toward Biogen and the FDA, following Aduhelm’s approval. 

Many have criticized Biogen’s decision to set Aduhelm’s list price at $56,000 per year, well above what analysts and advisory groups had predicted, even though the drug showed murky benefits in clinical trials. The FDA is requiring Biogen to conduct a confirmatory study to prove the drug's benefits, but Biogen CEO Michel Vounatsos has said the company has 9 years to finish that work.

In a letter to the Senate Finance Committee late last month, Sens. Elizabeth Warren, D-Massachusetts, and Bill Cassidy, R-Louisiana, called for a hearing to “examine the vexing new questions and challenges” the newly FDA-approved Aduhelm poses to the Medicare program.

Meanwhile, Sen. Joe Manchin, D-West Virginia, called on President Joe Biden in a letter in June to remove interim commissioner Dr. Janet Woodcock, citing the agency’s Aduhelm approval as reasoning. 

For its part, the FDA has defended its decision, pointing to Aduhelm’s ability to substantially lower amyloid plaque—a defining characteristic of Alzheimer’s—better than other similar drugs that have previously failed.