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FDA Black Hole for Reporting Becomes More Consumer-Friendly


Consumers may not realize it, but the U.S. Food and Drug Administration (FDA) currently has no way to track problems with medical devices and drugs that go wrong other than voluntary reporting. Unlike other countries that have drug and device registries, the FDA has an absolute head-in-the sand approach to keeping abreast of metal hip injures or a drug that causes birth defects.

Why is post-approval monitoring important?


A head in the sand approach to drug and device safety.

In Australia, the country’s National Joint Replacement Registry keeps track of medical devices after they are implanted. As a result, back in 2007, it was the first to report that the DePuy ASR hip had a high revision rate which was a red flag that the hips were failing prematurely, according to a report in the British Medical Journal.

DePuy, the orthopedics division of U.S.- based Johnson & Johnson, received 17 warning from the Australian registry between 2007 and 2009. After receiving the reports, in 2010 DePuy recalled 93,000 ASR hips from the worldwide market.

The FDA is now attempting to step up its post-approval monitoring by making it easier for consumers, doctors and health facilities to report complications.

On this 20-year anniversary of the FDA’s MedWatch program, the agency along with AARP, Consumers Union and the National Women’s Health Network has improved the reporting experience to MedWatch by creating a more user-friendly form that most people can read and understand.

Consumers who experience problems with any product the FDA regulates – from cosmetics to energy drinks, from drugs to permanent medical implants – should report the problem to the MedWatch program. This is an obvious improvement from the FDA’s MAUDE data base.

The Manufacturer and User Facility Device Experience (MAUDE) database was intended to become the place where manufacturers, health care providers and facilities and consumers reported “adverse events” or bad outcomes. But one visit to MAUDE would be your last. That’s because it is so difficult and cumbersome to maneuver. The consumer must understand technical regulatory jargon, the category of the implant, lot number etc. – information most consumers do not have.

The truth is MAUDE was so ineffective that years ago the GAO predicted about 1 percent of actual complications were ever reported.

Sort of like a black hole, the MAUDE database has been a less than satisfactory way to track how products perform in real-life situations. It appears the FDA is finally listening, and with some input from consumer groups, will get a better handle on what happens after medical devices are let loose on an unsuspecting public.

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