FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Gottlieb Says User Fees Will Pay for Post-Market Surveillance Amid Shutdown

Jan. 16, 2019

As the partial government shutdown continued, FDA Commissioner Scott Gottlieb announced that the agency will re-allocate user fee money from drug reviews to cover post-market drug safety surveillance.

Gottlieb said the agency is currently analyzing where to focus resources and funds amid the funding lapse. “One action we’ll be taking is to re-allocate user fee money from certain pre-market drug review work to post-market drug safety surveillance,” he said.

Gottlieb said the agency is reviewing its portfolio to ensure that its consumer protection functions continue uninterrupted. FDA activities that most directly impact safety will continue “to the best of our abilities, subject to the legal and financial limitations of the current circumstances,” he said.

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