(Reuters) – An independent federal review has been launched into the U.S. Food & drug Administration’s accelerated approval pathway using which the agency approved Biogen Inc’s Alzheimer’s treatment Aduhelm.
The probe will be undertaken by the Office of the Inspector General at the Department of Health and Human Services.
The listed date for the completion of the review is 2023 but the agency said there is potential for the review to be completed sooner, with some results being delivered by next year.
The agency will review a sample of drugs which were approved using the accelerated approval pathway, including Aduhelm, to find out if the FDA compiled with all relevant procedures and policies during the process.
The scientific appropriateness of the FDA’s approval of any of the drugs are not under review.
The FDA has faced heavy criticism for approving the Biogen drug without definitive evidence of patient benefit and over objections of its own panel of outside experts. The agency’s relationship with Biogen has also come under scrutiny.
“We will determine if the application of FDA’s pertinent policies and procedures allow for inappropriate relationships with pharmaceutical officials and other external entities,” HHS OIG spokeswoman Tesia Williams said in a statement.
The FDA approved Biogen’s Aduhelm on June 7 despite one of its two large-scale clinical trials failing to show a benefit to patients.
The FDA has granted the so-called “accelerated approval” in more than 250 instances since 1992, mainly for rare diseases or small patient populations that have had no effective treatments available to them. In these cases, the agency requires that drugmakers conduct additional clinical trials to prove their therapy works, or face withdrawal from the market.
(Reporting by Mrinalika Roy in Bengaluru; Editing by Maju Samuel)
