FDA's medical approval process faces GAO scrutiny

The Government Accountability Office is scheduled to release a report next month on the FDA's medical device review process, but the facts that we have available to us already suggest that things are seriously amiss.

The FDA itself admits that it doesn't feel the need to either establish that medical devices are actually beneficial, or compare them to existing treatments. All it does in most medical device reviews is make sure that each device performs the tasks it says it's supposed to (without checking on whether it has a therapeutic effect) and doesn't offer any obvious dangers to the patient.

Meanwhile, Medicare offers incentives to doctors to use new devices; the intention is to help encourage them to take the time to learn about new devices, but the result is that doctors may sometimes overuse medical device treatments that have not been vetted for their effectiveness. For example, some devices go through trials with as few as 25 patients. While the pharmaceutical approval process may have some flaws, at least it never approves a drug with such a scanty review process.

Knowing all of this, the GAO's report next month on medical device approval is likely to be very interesting reading.

To learn more about this problem:
- read this New York Times piece [1]

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FDA to notify doctors of drug, device issues via Internet [4]