OIG Says FDA Lacks Comprehensive REMS Data


Company News Release

Office of the Inspector General (OIG) recently released its finding on the FDA's effective of the Risk Evaluation and Mitigation Strategies (REMS), which are for drugs associated with known or potential risks that may outweigh the drugs’ benefits. It reviewed approved REMS since the program's inception in 2008 through 2011 and conducted structured interviews with FDA officials about FDA’s efforts to evaluate REMS components. It also reviewed 49 sponsors’ REMS assessments and FDA’s reviews of these assessments to determine the extent to which sponsors’ assessments were complete, were submitted to FDA within required timeframes, and indicated that REMS were meeting their goals. We also determined whether FDA evaluated theelements to assure safe use (ETASU) of one drug in each year of the program, as required by Federal law. The OIG found, as noted by the report's title, the FDA lacks comprehensive data on REMS. Specifically, nearly half of sponsor assessments for the 49 REMS we reviewed did not include all information requested in FDA assessment plans, and 10 were not submitted to FDA within required timeframes. FDA determined that 7 of the 49 REMS we reviewed met all of their goals. However, FDA has not identified reliable methods to assess the effectiveness of REMS. Finally, FDA’s assessment review times exceeded its goal of 60 days for all but one sponsor assessment, which reduces sponsors’ time to make suggested changes before submitting subsequent assessments.

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