The current accelerated process, which can last weeks to about five months, has greenlighted more than 300 drugs, according to the Journal. Full approval can take up to 10 months.
While drugmakers promise to conduct follow-up testing after approval, the tests can take years or not happen at all. If the new legislation passes, the FDA can require drugmakers to perform large-scale, follow-up tests after approval and pull any products that don’t work, according to the Journal. Industry experts told the Journal the proposed legislation would give the agency “explicit legal authority” in withdrawal requests and ease the recall process.
The proposal comes after Biogen’s high-cost Alzheimer’s drug, Aduhelm, floundered in gaining coverage by insurers, including Medicare. The biotechnology company’s CEO resigned in May.
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