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Report (OEI-04-11-00510)

FDA Lacks Comprehensive Data To Determine Whether Risk Evaluation and Mitigation Strategies Improve Drug Safety

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FDA requires manufacturers to submit structured plans, known as Risk Evaluation and Mitigation Strategies (REMS), for drugs associated with known or potential risks that may outweigh the drugs' benefits. If FDA does not properly monitor REMS' performance, it cannot ensure that the public is provided maximum protection from a drug's known or potential risks. However, FDA does not have the authority to require, but may request, drug manufacturers (i.e., sponsors) to submit specific information regarding REMS' effectiveness.


We reviewed approved REMS since program inception in 2008 through 2011 and conducted structured interviews with FDA officials about FDA's efforts to evaluate REMS components. We 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 the elements to assure safe use (ETASU) of one drug in each year of the program, as required by Federal law.


FDA approved 199 REMS between 2008 and 2011, 99 of which were still required in 2012. 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.


Our findings raise concerns about the overall effectiveness of the REMS program. To address these concerns, we made seven recommendations regarding FDA's evaluation and assessment of REMS and its review of sponsors' REMS assessments. FDA concurred with six of our recommendations. For the remaining recommendation, to seek legislative authority to make FDA assessment plans enforceable, FDA did not state whether it concurred or did not concur. However, FDA agreed that this recommendation should be considered if another opportunity arises to pursue legislative changes to the statutory provisions that describe the requirements for REMS assessments.

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