Abstract
Pharmaceutical Industry–Initiated Postapproval Studies—Not Requested by the US FDA, Little Value, and Many Questions
Highlights
The study by Skydel et al[1] published in JAMA Network Open examined all 110 new therapeutics approved by the US Food and Drug Administration (FDA) from 2009 through 2012 and identified 37 for which there were no postmarketing requirements or commitments.[1]
Most contemporary approvals of new oncology therapeutics are made on the basis of surrogate outcomes, and 5 years after approval, 50% have not demonstrated an overall survival benefit.[3]
There is some disagreement in the literature, most agree that the shorter review time associated with priority approvals leads to the identification of more postmarket safety problems.[4]
Summary
The study by Skydel et al[1] published in JAMA Network Open examined all 110 new therapeutics approved by the US Food and Drug Administration (FDA) from 2009 through 2012 and identified 37 for which there were no postmarketing requirements or commitments.[1]. Why didn’t the FDA require postapproval studies for one-third of the therapeutics it approved? Premarket oncology trials are more likely to be single-arm, open-label, and nonrandomized trials.[2] Most contemporary approvals of new oncology therapeutics are made on the basis of surrogate outcomes, and 5 years after approval, 50% have not demonstrated an overall survival benefit.[3] there is some disagreement in the literature, most agree that the shorter review time associated with priority approvals leads to the identification of more postmarket safety problems.[4] Are there no important unanswered efficacy and safety questions for therapeutics with these characteristics?
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