Watchdog or Willing Partner?

The US Food & Drug Administration (FDA) is in the news again, but this time for all the wrong reasons. A study by the University of California researchers and articles published in the JAMA and the American Journal of Therapeutics slam the Federal institution's testing procedures for approving the effectiveness of a medical device prior to its launch and use. The study published in December 2009 has found that FDA approval was sanctioned solely based on results from a single device trial rather than multiple trials (and that most of the devices approved were based on a majority of un-randomized trials, if I may add from other sources) and without taking into account key factors such as safety and quality of the medical device.

Since the release of the study findings, many critics are accusing the FDA of being over-friendly towards the healthcare and pharmaceutical industry, which in any case is the popular opinion held by many consumers across the US in recent years. Dubbed the government lackey to the corporate bigwigs of the pharmaceutical industry, the FDA's policies and methodologies are being regarded as gradually slipping towards protecting the interests of major pharmaceutical companies rather than the consumer, which, unless I'm mistaken, is the whole point behind instituting a federal body such as the FDA. Looks like The Beatles were wrong after all - money (not love) is all you need. Isn't quite as catchy though...

The FDA has (understandably!!!) rejected the claims made by the University of California stating that it has "serious concerns with the approach" used by the researchers, which has apparently led them to making incorrect assumptions about the actual process behind the medical trial conduct and approval processes. However, in a move that can only be construed as a ploy to save face in light of these embarrassing accusations, the FDA has called for a complete revamping of its pre-market review process and has, in fact, commissioned a one-year study by the Institute of Medicine for the review.

While we can only appreciate the efforts made by the FDA to change its clearly dysfunctional processes, one would question the seriousness behind such an initiative, as this study is said to exclude the review of the pre-market clearance process of cardiovascular medical devices, which was the key issue highlighted by the University of California report. With such a crucial area of medical device safety shoved under the carpet, one can only wonder about the outcome of the FDA's study and the "revamping" that it is supposed to facilitate. It is now everyone's guess whether this entire protracted exercise will actually lead to meaningful and long-term changes in the FDA's future pre-market clearance approach.

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