House Oversight Probes How Voluntary REMS-Like Systems Affect Generic Market

The House oversight committee will hold a hearing Wednesday (March 22) on the impact of voluntary restricted distribution systems -- programs the Association For Accessible Medicines say “mimic FDA [Risk Evaluation Mitigation Strategies] programs, or hide behind the veneer of patient safety and FDA mandates,” but are used by brand companies to restrict access to samples for bioequivalence testing and delay generic competition. The move by the watchdog committee comes as lawmakers continue to point to generic competition as an...