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Report Questions Benefit of FDA Accelerated Approval Pathway

Last Updated: July 30, 2021.

FRIDAY, July 30, 2021 (HealthDay News) -- Many of the drugs in the U.S. Food and Drug Administration accelerated approval pathway have not been confirmed as clinically effective, despite the requirement for postapproval confirmatory trials, according to an investigation published online July 29 in The BMJ.

Elisabeth Mahase, a clinical reporter at The BMJ, examined the status of drugs on the FDA accelerated approval pathway, established in 1992, allowing drugs onto the market before efficacy has been proved. Since then, 112 of the 253 drugs authorized have not been confirmed as clinically effective.

According to Mahase, 24 of the 112 drugs that have not been confirmed as clinically effective have been on the market for more than five years. Only 16 drugs approved through the accelerated approval pathway have been withdrawn; most were shown to lack efficacy, but in some cases, the confirmatory trials were never conducted. Manufacturers of 24 treatments that have been on the market for more than five years were asked about phase IV trials: six of the drugs had been withdrawn, approved, or postponed; six others had relevant trial information; and manufacturers of 12 drugs did not respond to the request.

"All experts who spoke to The BMJ agreed that the accelerated pathway was still useful and could be truly beneficial to patients, although some changes were needed," Mahase writes. "One effective reform could be for confirmatory trials to be designed, agreed, and even started as part of the approval, and the FDA needs to be stricter in enforcing its own rules."

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