According to numerous media reports, a Food and Drug Administration official who was allegedly inappropriately intimate with the makers of the controversial Alzheimer’s drug Aduhelm will resign from the role immediately.
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.
Subsequent media and congressional investigations show that Dunn had an informal meeting with Biogen’s chief scientist two years ago to initiate an unusually close collaboration leading up to the approval. A congressional report released on Wednesday found that some of Biogen’s documents about the drug were produced by the FDA, which worked with the company to co-write the briefing document. A congressional report concluded that the FDA did not follow its own rules in its “unusual” interactions with Biogen and “improperly cooperated” with the company. It also called the price of Aduhelm “unreasonably high”.
Stat News reportedly told management on Friday that he was stepping down. On 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 in rebuilding its human food program in response to the formula debacle.
