FDA Accused of Lax Drug Safety Enforcement

By Elizabeth Rhein

Published on June 28, 2006

California Democrat, Rep. Henry A. Waxman, has compiled and released the worrisome statistics that show the FDA's apparent lapse in enforcement. According to Rep. Waxman's office, the Food and Drug Administration released 54 percent fewer so-called "warning letters" to companies in 2005 than in 2000. This number is in stark contrast to the number of actual violations reported to the FDA by its field inspectors, which remained relatively constant from 2000 to 2005.

The statistic seems to suggest that the FDA is no longer effectively cracking down on food and drug companies who produce unsafe products.

A spokesman for the FDA has claimed that these numbers cannot be considered representative of the overarching safety work done by the agency, and went on to point out the major safety measures decreed by the FDA in 2005. These included the banning of popular antidepressant Paxil as well as diabetes drug Avandamet and defective medical products by Baxter and Vail Products. The FDA says that these actions cannot be measured in terms of warning letters and other enforcement procedures.

The Representative's accusations coincide with proposed legislation in the Senate that would overhaul the safety precautions taken by the FDA and drugmakers.

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