Health Affairs August 1, 2023
In 1992, the Food and Drug Administration (FDA) initiated the Accelerated Approval Program to “allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need” based on research using a surrogate endpoint to demonstrate a drug’s effectiveness. After approval, drug companies are still expected to conduct confirmatory trials aimed at showing that the drug does in fact provide a clinical benefit.
Since the program’s inception, a central concern has arisen: the possibility that unnecessary delays in confirmatory trials may be resulting in the prolonged use of drugs for which there is no verified clinical benefit or insufficient clinical benefit to justify the risks associated with the drug. A drug is granted accelerated approval when the...
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