Reactions 1441 - 2 Mar 2013

REMS lack data, according toUS Inspector General

For drugs with risks that may outweigh the benefits,manufacturers are required by the US FDA to submit anenforceable, structured plan to manage each specificrisk. These plans are known as Risk Evaluation andMitigation Strategies (REMS). Monitoring of theperformance of REMS by the FDA protects the publicfrom the known or potential risks of such drugs.

According to a review by the Office of InspectorGeneral (OIG) of the US Department of Health andHuman Services of all 2008–2011 REMS, 199 wereapproved by the FDA, and 99 were still required in 2012.The OIG also reviewed 49 manufacturers’ assessmentsof REMS, and the FDA’s reviews of these assessments.Many manufacturer assessments were incomplete, orincluded data that did not meet FDA standards. The FDAconsidered 7 of the 49 REMS to be meeting all of theirgoals, but that 21 were not.

US Federal Law requires that the FDA evaluates theelements to assure safe use (ETASU) of one drug in eachyear of the REMS program. Only 1 of 32 drugs withETASUs has been evaluated.

These findings raised concerns of the effectiveness ofthe REMS programme, and the OIG has devised anumber of recommendations to the FDA concerning theevaluation and assessment of REMS, and the reviewprocess of manufacturers’ own REMS assessments. TheFDA concurred with, and are acting upon, most of theserecommendations.Department of Health and Human Services. FDA LACKS COMPREHENSIVEDATA TO DETERMINE WHETHER RISK EVALUATION AND MITIGATIONSTRATEGIES IMPROVE DRUG SAFETY. Internet Document : [38 pages], 1Feb 2013. Available from: URL: https://oig.hhs.gov/oei/reports/oei-04-11-00510.pdf 803083806

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Reactions 2 Mar 2013 No. 14410114-9954/10/1441-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved