Reactions 1400 - 5 May 2012 FDA enhances oversight of postmarket drug safety Efforts to strengthen and modernise the US FDA’s postmarket drug safety programme over the past few years have resulted in substantial improvements in the agency’s oversight of the safety of marketed drugs, says a report by the agency’s Center for Drug Evaluation and Research (CDER). New scientific tools and enhanced capabilities allow the agency to "give the same priority to postmarket drug safety monitoring as to premarket drug review". In 2004, the CDER introduced a comprehensive plan to strengthen drug safety. This was further enhanced with the passage of the FDA Amendments ACT (FDAAA) of 2007. Since 2008, the FDA has required 65 safety- related labelling changes (in addition to the labelling changes made voluntarily by drug manufacturers). The agency has also required the implementation of 64 complex Risk Evaluation and Mitigation Strategies (REMS), including some which restrict access to certain high-risk products. In 2011 alone, the CDER issued 68 drug safety communications, up 75% from the year before. CDER director Janet Woodcock, M.D. says "This report shows that the quality, accountability, and timeliness of postmarket drug safety decisions have been enhanced, and our public communication of this information is more effective." U.S Food and Drug Administration. Report: FDA strengthens monitoring of post- approval drug safety. Media Release : 21 Apr 2012. Available from: URL: http:// www.fda.gov 809136138 1 Reactions 5 May 2012 No. 1400 0114-9954/10/1400-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

FDA enhances oversight of postmarket drug safety

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Reactions 1400 - 5 May 2012

FDA enhances oversight ofpostmarket drug safety

Efforts to strengthen and modernise the US FDA’spostmarket drug safety programme over the past fewyears have resulted in substantial improvements in theagency’s oversight of the safety of marketed drugs, saysa report by the agency’s Center for Drug Evaluation andResearch (CDER). New scientific tools and enhancedcapabilities allow the agency to "give the same priority topostmarket drug safety monitoring as to premarket drugreview".

In 2004, the CDER introduced a comprehensive planto strengthen drug safety. This was further enhancedwith the passage of the FDA Amendments ACT (FDAAA)of 2007. Since 2008, the FDA has required 65 safety-related labelling changes (in addition to the labellingchanges made voluntarily by drug manufacturers). Theagency has also required the implementation of64 complex Risk Evaluation and Mitigation Strategies(REMS), including some which restrict access to certainhigh-risk products. In 2011 alone, the CDER issued68 drug safety communications, up 75% from the yearbefore.

CDER director Janet Woodcock, M.D. says "Thisreport shows that the quality, accountability, andtimeliness of postmarket drug safety decisions havebeen enhanced, and our public communication of thisinformation is more effective."U.S Food and Drug Administration. Report: FDA strengthens monitoring of post-approval drug safety. Media Release : 21 Apr 2012. Available from: URL: http://www.fda.gov 809136138