Florida congressman says Aduhelm’s FDA approval ‘muddied the waters’ for future Alzheimer’s drugs

Rep. Neal Dunn (R-Fla.) on Tuesday said the controversial federal approval of the Alzheimer’s medication Aduhelm “muddied the waters” for other potential treatments for the disease.

Dunn on Tuesday appeared at “Accelerated Approvals & the Pathway to Treatments,” a virtual event hosted by The Hill aimed at discussing the future of treatment for Alzheimer’s disease. The event was sponsored by the nonprofit Alzheimer’s Association.

While speaking with The Hill Editor in Chief Bob Cusack, Dunn said that there were currently 20 to 30 “promising” Alzheimer’s drugs in different stages of trials.

“There’s a lot of promise out there. So I think something’s going to come across the finish line soon. The first one to make it across is of course aducanumab, or it’s sold under the name Aduhelm. So that was the first one, and it muddied the waters because it had a very abnormal approval process” said Dunn, who himself is a physician.

In June, the Food and Drug Administration (FDA) granted “accelerated approval” to Biogen’s drug despite conflicting evidence over whether it was truly effective at slowing the progression of Alzheimer’s.

Multiple members of the FDA’s expert advisory panel resigned following the approval of Aduhelm, with Harvard Medical School professor Aaron Kesselheim calling it “probably the worst drug approval decision in recent U.S. history.”

The high price of Aduhelm also elicited controversy, with the drug costing about $56,000 a year before Biogen announced it was halving the price to $28,200 for an average-weight patient. Earlier this month, the Centers for Medicare and Medicaid Services (CMS) announced it would be limiting coverage of the drug to people participating in a clinical trial to determine Aduhelm’s efficacy.

Dunn on Tuesday said the FDA and CMS should divide their responsibilities when it comes to drug approval and coverage.

“I would say that you don’t want FDA to be thinking about pricing. You don’t want CMS to thinking about ‘is the drug any darn good?’ You’d like to know before CMS gets involved, you want them to know that they’ve got a drug that’s safe and efficacious or if it’s only borderline,” Dunn said.

Dunn warned that coupling the responsibilities of efficacy determination and coverage could risk losing public confidence federal health authorities, which he noted was already at an all-time low.