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Harvard Team Finds Increased Approvals With Less Data in 40-Year FDA Review

January 23, 2020

It may be time to simplify the FDA’s many expedited review programs, according to a Harvard research team that studied the agency’s drug reviews over the past four decades.

Overhauls of the FDA’s drug approval procedures and programs since the early 1980s have increased competition — but the agency is now approving new drugs based on less evidence, according to the study reported in JAMA.

Researchers Jonathan Darrow, Jerry Avorn and Aaron Kesselheim traced the course of the FDA’s drug approvals over the last four decades, finding that the agency gradually began taking less time on drug reviews and accepting less data from applicants.

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