Raja Sékaran Discusses Backlash Surrounding Aduhelm Approval

Raja Sékaran was quoted in the Radar on Drug Benefits article, “Aduhelm Approval Prompts Backlash, Could Bring Investigation” (subscription required). The article examines how Aduhelm, an Alzheimer’s drug manufactured by Biogen and recently approved by the FDA, seems unlikely to make it to market at this time, as numerous parties in the medical field are publicly opposed to it. FDA approval could also be stalled, as the agency’s acting commissioner has called for the HHS Office of Inspector Gener­al (OIG) to investigate the process that led to the approval.

Commenting on the matter, Raja said he “expects OIG will take a look at the Aduhelm process” and that the OIG “will follow [Commissioner Woodcock’s] request and do an investi­gation, [since] the head of the [FDA] itself is asking for the investigation.” 

“This is unusual, because it’s responding to certain events and ac­cusations,” he continued. “Given the disease that we’re talking about and where it [Aduhelm] is in the approval process — having been approved for a narrow use — I would think that the pressure is really on to make it clear where this is headed in the short term. Congress is watching, as well as the public and the press, so I cannot imagine that they have a long window of time to sort through everything. I think they really have to get on it right away.”

Raja said he expects that the OIG will “take a look at the details of the communications between the Biogen representative and anyone and everyone involved on the FDA side of the approval process. I think they’ll want to look at emails, correspondence and documents. And I think they’ll do some interviews.”

He added, “OIG has subpoena power that does not require signoff from a judge…[subpoenas] can be issued quite quick­ly....and in a situation like this, I imagine that if the investigation is opened, [subpoenas] will be issued to the drug company itself. Within the FDA, I will be in­terested to see whether they think a subpoena is required. I would suspect that, because it’s a government agency, and it’s overseen by OIG, that an intra-department request would suffice.”  

He closed by saying that if the OIG does find any wrongdoing in the Aduhelm approval process, FDA employees could be “subject to internal discipline or termination.”

Radar on Drug Benefits is a publication of AIS Health.