REMS Take Effect; FDA Identifies 16 Products With RiskMAPs That Qualify
Executive Summary
Manufacturers of approved products whose marketing conditions qualify for a Risk Evaluation and Mitigation Strategy will have to develop a timeline for the assessment of their risk management efforts by September 21
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Manufacturers of approved products whose marketing conditions qualify for a Risk Evaluation and Mitigation Strategy will have to develop a timeline for the assessment of their risk management efforts by September 21. "We are listing those manufacturers of prescription drug and biologic license applications that have an existing risk management plan that we are now deeming to be a REMS or meeting the risk evaluation and mitigation strategy criteria," FDA Commissioner Andrew von Eschenbach announced at the Food and Drug Law Institute annual conference March 26. With the FDA Amendments Act provision covering REMS taking effect March 25, those manufacturers now have six months to submit a REMS proposal. While the proposals may largely involve explaining why ongoing risk management activities fulfill the REMS requirements, firms will need to establish a timetable for the program's effectiveness. For new drugs, FDAAA stipulates that evaluations should generally be made at 18 months, three years and seven years after approval. Under FDAAA, approved products that "have elements to assure safe use" are deemed to have REMS. FDA has identified 16 approved products, all of which have existing Risk Management Action Plans, that it believes qualify (see chart: " 1 Retroactive REMS "). Elements to assure safe use, which are typically found in RiskMAPs, include: health care providers who prescribe the drug have particular training or experience, or are specially certified; pharmacies, practitioners or health care settings that dispense the drugs are specially certified; the drug is dispensed to patients only in certain health care settings, such as hospitals; the drug is dispensed with evidence or other documentation of safe use conditions, such as laboratory test results; each patient using the drug is subject to certain monitoring; or each patient using the drug is enrolled in a registry. In a March 26 Federal Register notice, FDA clarified that "a drug will not be deemed to have a REMS if it has only a Medication Guide, patient package insert, and/or communication plan." FDA is in the process of developing a guidance on the preferred content and format of proposed REMS and is revising its guidance on the development and use of RiskMAPs (2 (Also see "Risk Management Guidance Suggests Advisory Cmte Review For RiskMAPs" - Pink Sheet, 28 Mar, 2005.), p. 3). - Brian Marson ([email protected]) |