After the controversial FDA approval of Aduhelm, Biogen’s Alzheimer’s disease therapy, the agency’s acting commissioner is calling for an investigation by the HHS Office of Inspector General (OIG). OIG has outlined why it plans to investigate FDA and what it will look at. All of this is happening while physician trust in the FDA is declining to new lows.
Head of FDA Calls for Investigation
The FDA’s relationship with Biogen ahead of its controversial approval of the drugmaker’s Alzheimer’s disease therapy, Aduhelm, has been at the center of calls for an investigation. Now, FDA’s acting commissioner, Janet Woodcock, M.D., requested the Office of Inspector General conduct an independent investigation into the agency’s decision to approve Aduhelm. Woodcock noted that there “continues to be concerns raised” regarding the contact between FDA officials and Biogen ahead of the agency’s decision, “including some that may have occurred outside of the formal correspondence process.”
Woodcock’s request follows an report from Stat that found Biogen executives 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.
HHS OIG
According to the U.S. Department of Health and Human Services, Office of Inspector General, it will investigate FDA, and its concern arises from the agency’s approval of Aduhelm due to alleged scientific disputes within the FDA, the FDA advisory committee’s vote against approval, allegations of an inappropriately close relationship between the FDA and Biogen, and the FDA’s use of the accelerated approval pathway. In response to these concerns, OIG states it will assess how the FDA implements the accelerated approval pathway. This will include reviewing interactions between the FDA and outside parties as well as other aspects of the process, such as deciding on this pathway and scientific disputes. OIG will review the FDA’s relevant policies and procedures, determine compliance with them, and make appropriate findings and recommendations based on a sample of drugs approved using the accelerated approval pathway, which will include Aduhelm. OIG stressed it will not assess the scientific appropriateness of the FDA’s approval of any of the drugs under review and there may be multiple reports issued.
Physician Trust in FDA Declining
As reported by Fierce Pharma, physicians are losing trust in the FDA due to the agency’s recent controversial approvals. Physicians’ trust in the agency is plummeting, according to a recent survey by Spherix Global Insights. More than 40% of the doctors surveyed said their confidence in the FDA has dropped over the past year
Doctors cited a range of problems—including suspected political motivations and lack of transparency—as frustrating pain points in the July survey of 252 specialty nephrologists, neurologists, dermatologists, rheumatologists and gastroenterologists. Neurologists are particularly discouraged—84% have lost confidence in the FDA over the past year, Spherix found. The controversial approval of Biogen’s Aduhelm in June is the key culprit; 82% of neurologists disagreed with the FDA nod.
“It wasn’t so much the specialists feeling that the FDA was being too aggressive or too lax, but just erratic,” Spherix President Jennifer Robinson said in the Fierce Pharma article. “In the past, if a company hit all their endpoints and nothing funky came out of the clinical trial—and the trial was designed in conjunction with the FDA—we were pretty much expecting an approval.”