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Thursday, May 31st 2012

International Medical Device Sales Should Have More Regulation

I can’t believe that title considering my typical political ideology. But consider the case of DuPuy’s ASR hip.

The health care products giant Johnson & Johnson continued to market an artificial hip in Europe and elsewhere overseas after the Food and Drug Administration rejected its sale in the United States based on a review of company safety studies.


There is no suggestion that Johnson & Johnson broke the law. Regulatory standards in other countries, like those in Europe, for approving the sale of medical devices are typically lower than here. A spokeswoman for a British regulatory agency, the Medicines and Healthcare Products Regulatory Agency, said that companies like Johnson & Johnson were not required to notify it when the F.D.A. refused to approve a product that was used in patients there.

The ASR is now under recall.

I guess I’m not truly in favor of MORE regulation. But if you’re going to have regulation in place, it seems reasonable for different regulatory agencies to communicate across international lines. It seems a small step for every medical device regulatory agency to require companies to report decisions on their devices from other regulatory agencies. So, say, if DuPuy got a non-approval letter from the FDA they would be required to let the MHPRA in the United Kingdom know that. The bureaucrats in England can do whatever they want with that information – no one is holding them to the same decision as the FDA – but it would provide them with a better picture as they regulate the DuPuy’s device.