Abuse Deterrence: US Exclusivity Update May Ride User Fee Coattails

CDER's Woodcock suggests exclusivity rules outdated for abuse-deterrent technology development, and Rep. Griffith takes it to mean legal changes are needed.

Rx product exclusivity laws, as they relate to abuse-deterrent formulations of pain treatments, seem ripe for adjustment in the upcoming user fee legislative package to better encourage product development in the US.

Rep. Morgan Griffith, R-Va., asked Center for Drug Evaluation and Research Director Janet Woodcock during a recent hearing on the...