Evaluation of current risk evaluation and mitigation strategies

Abstract

Objective: To review characteristics of active REMS in the US for drugs with significant known risks. Methods: For the ISPE abstract, we identified all drugs recognized by the FDA as having an active REMS as of October 31, 2008. To provide the most up-to-date information in this rapidly changing regulatory environment, REMS approved through July 31, 2009 are included in the results for the poster. This survey of programs updates a review previously published. Authors reviewed publicly available information (e.g., www.fda.gov, published articles, and product labels) to identify the safety issue prompting the REMS; the original indication for the products; the nature of REMS elements, including medication guide, communication programs, elements to assure safe use; and whether the REMS was approved at the time of or following drug approval. Results: A total of 69 drugs were identified as having an approved REMS (14 “deemed” REMS as listed in the Federal Register4 and 55 subsequently listed on the FDA website3). Of the 69 REMS, 52% (n = 36) required only medication guides, 28% (n = 19) required communication plans, 28% (n = 19) required elements of safe use (13/19 are for drugs deemed to have approved REMS), and 13% (n = 9) required an implementation system. The total number of REMS approved so far in 2009 (n = 31) accounts for 45% of all REMS approved. Figure 2 shows the trend in REMS components over time since March 2008. Abstracts from the 25th International Conference on Pharmacoepidemiology & Therapeutic Risk Management