FDA Embarks on New “Swift and Aggressive” Enforcement Approach

Nov 03, 2010   

The FDA has recently published its Strategic Priorities document on its website. Found here, the draft document outlines the Agencys goals for the years 2011-2015. According to the document, a variety of new programs will be instituted by the FDA in order to “sharpen the effectiveness and timeliness of its regulatory, compliance, and enforcement systems.” Reinforcing its commitment to “swift, aggressive enforcement actions to protect public health,” the goals contained in this document mirror those found in the Agencys recent Enforcement Strategy document.

Found here, the Enforcement Strategy document may be seen as a marked shift to more vigorous enforcement efforts by the FDA. Howard Sklamberg, Director of the Office of Enforcement at the Agency, has confirmed that the FDA is looking to step up its enforcement efforts. Referencing this newly-published document and other newly-published information on the Agencys website, Sklamberg noted that the FDA will no longer be extending warning letters to those deemed “repeat offenders.” Sklamberg suggested that this new “swift and aggressive” strategy will further the overall goals of the Agency, noting that its enforcement measures are designed to deter noncompliance. To this end, the “FDA will use any and all available enforcement tools, as appropriate, based on the facts of the case and the nature and seriousness of the violation.”

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