Thursday, February 19, 2009

Report: FDA lack of enforcement of testing standards "stunning in its contempt" for patients

According to a report released February 18 by the non-profit Project on Government Oversight, the recent failure of the Food and Drug Administration to enforce federally-mandated safety and quality standards with regard to medical devices places patients' lives in danger and raises “incalculable risks” to public safety. News of this report appears in Wednesday's Wall Street Journal (subscription required for full article) and was also reported by the Associated Press.

In particular, the report noted a dramatic decline in FDA inspections of plants producing medical devices such as coronary stents, pacemakers, defibrillators, and heart valves. According to the report, there were 33 such inspections in 2005, 7 in 2007, and just 1 in 2008. Without inspections, the FDA relies on manufacturers' assurances that they are following federal guidelines, which provides manufacturers significant protection from disciplinary action by the FDA as well as from prosecution. The FDA's lack of action is “stunning in its contempt for the protection of patients," the report concludes.

A 2006 internal FDA memo pointed out multiple instances in which medical device manufacturers had failed to comply with federal testing standards, and suggested increased governmental oversight. However, the FDA elected at that point not to increase its inspections of the production of those devices. "This decision . . . may result in an irreversible cascade of adverse consequences to the protection of the public," according to a letter submitted to Congress by the Society of Quality Assurance.

The FDA's lack of oversight of the medical industry is especially troublesome given the latest attempt by the Georgia legislature to provide blanket immunity from liability to the pharmaceutical industry in certain circumstances where a product has received FDA approval. In addition to this most recent report, the FDA's failure to fulfill its mandate to protect the public has been well documented.

Contributed by John D. Hadden
Turkheimer & Hadden, LLC

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