Trends In: FDA Enforcement Actions

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Pharmaceutical Technology, Pharmaceutical Technology-11-02-2008, Volume 32, Issue 11

During the past five-plus years, the number of US Food and Drug Administration enforcement actions seems to have dropped significantly in the areas of seizures, permanent injunctions, and warning letters (see table). One may question whether the drop means companies are in better compliance these days, or whether FDA's drained resources are preventing the agency from following up every potential violation. Alyson Saben in the Office of Enforcement at FDA's Office of Regulatory Affairs provided some insight into this issue.

FDA Enforcement, FY 2003–FY 2008.


"In many cases, agency enforcement actions are taken for matters that are of greatest public health concern and which will have the greatest impact on consumer protection," she said. "We cannot measure the agency's enforcement success—nor can we measure industry compliance—by counting warning letters and other actions, individually."

These actions represent only a small portion of the "full spectrum of FDA's compliance efforts and the overall impact of those actions on consumer protection," adds Saben. For example, the statistics in the table do not include the accomplishments of FDA's Office of Criminal Investigations (OCI). In fiscal year 2008 (FY 2008), as of Sept. 10, OCI initiated 405 criminal investigations, made 319 arrests, and secured 311 convictions with fines, restitutions, and other monetary penalties totaling more than $153 million.

In addition, FDA's efforts in the import arena have a large impact in the enforcement arena. In 2007, the agency processed approximately 16 million lines of FDA-regulated products contained in import entries. Through the use of administrative actions such as Import Alerts and sampling efforts at the border, numerous, potentially violative, FDA-regulated products of foreign origin were prevented from reaching US consumers. And numerous other FDA "interventions," including inspections, sample collections/analyses, and issuance of 483s, take place daily, explained Saben, which result in corrective actions and consumer protection.

"The agency also seeks to expand the impact of these actions through its communication efforts, thereby achieving a broader, potential deterrent effect industry-wide," says Saben.