On May 10, Prometheus Laboratories Inc. ("Prometheus") filed a Citizen Petition (FDA Docket No. FDA-2013-P-0572) requesting "complete notice and comment rulemaking establishing the standards and processes for a single, shared REMS [Risk Evaluation and Mitigation Strategies]" and waivers for the requirement for a single, shared REMS. Prometheus also requested that it be given notice and the opportunity to engage in any process used by FDA to determine whether to grant a waiver from the requirement for a single, shared REMS for Lotronex® (alosetron hydrochloride).
REMS are a type of risk management plan structure established by the Food and Drug Administration Act of 2007 ("FDAAA") in September 27, 2007. REMS are required for a drug to be approved or post approval based on new safety information if FDA determines "it is necessary to ensure that the benefits of the drug outweigh the risks of the drug." FDA may require a REMS to include a medication guide, patient package insert, and a communication plan. Where REMS get more complicated are when they include elements to assure safe use ("ETASU"), which generally involve more restrictive REMS, such as controlled distribution, special training for the physicians who prescribe the drug, typically to manage a serious risk, such as a severe side effect that may occur without such controls. REMS also involve a timetable for assessment to ensure that the REMS is controlling the risk for administering the drug. If a drug has a REMS, then generic version must have the same general elements and either share the same REMS with ETASU with the innovator or have its own essentially equivalent REMS with ETASU.
Lotronex® was approved on February 9, 2000 to treat irritable bowel syndrome in women whose predominant bowel syndrome is diarrhea. Soon after Lotronex® was marketed, FDA received reports of obstructed or ruptured bowels as a complication of severe constipation and sudden swelling/inflammation of part of the colon that occurs when there is a temporary loss of, or reduction in, blood flow to the colon. On November 28, 2000, Lotronex® was voluntarily withdrawn by its then sponsor GlasxoSmithKline ("GDK").