FDA Accepting Less Data, More Surrogate Endpoints in Trials

Over the last four decades, the FDA has loosened its requirements for approving new drugs, increasingly accepting less data and more surrogate endpoints in clinical trials, and shortening its reviews, according to a new analysis, as reported in Medscape.

Jonathan J. Darrow, SJD, JD, MBA, with Brigham and Women’s Hospital and Harvard Medical School in Boston, Massachusetts, and coauthors analyzed data from 1983 to 2018. The review was published online January 14 in the Journal of the American Medical Association. Among the evidence is that from 1995 to 1997, 80.6% of new drugs were approved on the basis of two pivotal trials — but that number dropped to 52.8% from 2015 to 2017.

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