The Accelerated Approval Integrity Act of 2022 (H.R. 6963) aims to remove loopholes in the Food and Drug Administration’s accelerated approval pathway. The bill, however, fails to adequately consider the whole picture, and may inadvertently remove medications that simply can’t complete confirmatory trials within the narrow timeframe allowed.
U.S. lawmakers requested data and documents from the Food and Drug Administration related to the regulatory agency’s accelerated approval of Biogen Inc.’s new Alzheimer’s drug, mounting further pressure on the FDA that has come under fire for clearing Aduhelm.
In an ongoing online hearing before the House Committee on Energy and Commerce’s Oversight and Investigation subcommittee, executives from across the pharmaceutical industry outlined the steps their companies are taking to combat Covid-19 and restore the world to a sense of normalcy.
