FDA Enforcement, FY 2003–FY 2008.
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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.
"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.
