Aug 4 - An independent federal review has been approved to the U.S. Food and Drug Administration's accelerated approval pathway using which the agency published the Alzheimer's treatment Aduhelm by Biogen Inc.
The probe will be completed by the Office of Inspector General at the Department of Health and Human Services.
The expected completion date of the review is 2023, but the agency says there is potential for the review to be completed sooner with some results expected 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 met all relevant procedures and policies during the process.
The scientific relevance of FDA's approval of any drugs are not under review.
The FDA has faced heavy criticism by the FDA for approving Biogen without definitive evidence of patient benefit and over objections by its own panel of international experts. The biogen relationship with the agency has also come under scrutiny.
She will determine if the application of FDA's inappropriate policies and procedures allow for inappropriate relations 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 small diseases or rare 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.