FDA Lacks Comprehensive Data to Determine Whether Risk Evaluation and Mitigation Strategies Improve Drug Safety   [open pdf - 2MB]

"The Food and Drug Administration (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. [...] 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."

Report Number:
U.S. Department of Health and Human Services, Office of Inspector General, OEI-04-11-00510
Public Domain
Retrieved From:
U.S. Department of Health and Human Services, Office of Inspector General: https://oig.hhs.gov/
Media Type:
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