A Food and Drug Administration official who had an inappropriate rapport with the makers of the controversial Alzheimer’s drug Aduhelm is resigning from his role. immediately effectiveaccording to lots of media coverage.
Billy Dunn, head of the FDA’s neuroscience division, has been with the FDA for about 18 years, during which time he was involved in the approval of several high-profile drugs. The public endorsement earned him notoriety. This drug has not been shown to be effective against Alzheimer’s disease and carries the risk of severe brain swelling.
In 2020, FDA’s Independent Advisory Panel almost unanimously agreed that FDA no Approve the drug (11 of 12 committee members voted against, 1 voted ‘uncertain’). Still, approval passed, and Aduhelm’s maker, Biogen, continued to charge him an exorbitant $56,000 for a year’s worth of treatment. Outside researchers called the approval “disgraceful,” three advisory committees resigned in protest, and Medicare sought to cover expensive drugs for Alzheimer’s patients desperate for new treatments. Part B insurance premiums have been raised to record amounts.
Suspicion of Subsequent Media and Congressional Investigations Dunn held a private meeting with Biogen’s head scientist Two years ago we started a very close collaboration leading up to the approval. For example, a congressional report released in December 2022 stated that some of Biogen’s documents on this drug were produced by the FDA, and that the FDA worked with the company to jointly prepare the briefing document. I understand. A congressional report concluded that the FDA did not follow its own rules in its “unusual” interactions with Biogen.improper cooperationThe company also called Aduhelm’s price “unreasonably high.”
Dunn reportedly told leadership on Friday that he was stepping down. According to statistics newsOn Monday, Peter Stein, director of the FDA’s Office of New Drugs, emailed staff about his retirement.
“It is with regret that I announce the resignation of Dr. Billy Dunn, Director of the Neuroscience Office,” Stein wrote. “After a long and highly productive career in public service, Billy has decided to retire from his FDA and explore other opportunities while continuing to focus on improving the lives of patients with neurological disorders. .”
Teresa Buracchio, deputy director of the neuroscience department, will replace Dunn as acting director for now, Stein added.
This departure comes as the FDA is working to recover from various scandals and missteps. This includes a dire national formula shortage and an oversight of e-cigarette products.On Tuesday, the agency reported progress Rebuilding the human food program of Responding to the Formula debacleLast week it was strengthen tobacco programs.