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

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