FDA Denies Prometheus’ Petition on Shared REMS Negotiations

The FDA rejected most of Prometheus Laboratories’ citizen petition on a single shared risk evaluation and mitigation strategy (REMS), rebutting claims that negotiations with a generic competitor on a shared system could violate antitrust laws. The citizen petition concerned a single shared REMS for Prometheus’ irritable bowel syndrome drug Lotronex (alosetron hydrochloride), which already has a REMS to address constipation and gastrointestinal adverse reactions.
Drug Industry Daily