Biogen Alzheimer’s Drug Approval to Get Inspector’s Probe
(Bloomberg) -- A federal watchdog said it will examine U.S. drug regulators’ use of an approval process intended to grant speedier access to experimental medicines.
The Food and Drug Administration’s accelerated approval pathway is meant to get potentially promising treatments to market faster by allowing use of therapies while drugmakers continue to study them. Its backers say it helps quickly address unmet medical needs.
Regulators have granted such clearances to a range of medications, including Biogen Inc. Alzheimer’s therapy Aduhelm. But some critics of the process say the FDA has used the pathway too often and that drugmakers sometimes fail to complete required follow-up studies.
On Wednesday, the U.S. Department of Health and Human Services Office of Inspector General said it plans to review the accelerated approval process, including concerns raised about contacts between FDA and Biogen officials before the clearance of Aduhelm.
“As part of our comprehensive assessment, we will determine if the application of FDA’s pertinent policies and procedures allow for inappropriate relationships with pharmaceutical officials and other external entities,” Tesia Williams, a spokeswoman for the inspector general, said in a statement.
The inspector general’s report is expected to be finalized in 2023. While the office said it will examine how the FDA selects drugs for accelerated approval, it won’t look at the scientific appropriateness of the agency’s clearance of any drug.
The FDA granted Aduhelm accelerated approval in June even though two clinical trials offered mixed signals about the drug’s efficacy. A committee of outside scientific advisers to the agency said the drug shouldn’t have been approved; three panelists have since resigned.
As part of its approval, Biogen must conduct another clinical trial, which it has almost nine years to do. Critics have argued Billy Dunn, director of the FDA’s Office of Neuroscience, had too close of a relationship with Biogen and was determined to approve the drug.
House Democrats are investigating the approval and pricing of Aduhelm, and senators have asked Finance Committee Chairman Ron Wyden to hold a hearing on the matter. Biogen priced Aduhelm at $56,000 a year.
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