FDA Warns Merck About Its Diabetes Drugs

Merck can’t say it wasn’t warned.

In what the FDA Law Blog calls the first of its kind, the FDA last month sent the pharmaceutical manufacturer notification that it violated its promise to conduct postmarket research (PMR) on its diabetes drugs Januvia and Janumet.

The letter represents new authority Congress granted the FDA to compel the pharmaceutical industry to conduct followup studies to assure a drug’s long-term safety after problems have been reported. Violations of this obligation can result in charges of misbranding, and in fines of $250,000 and potentially more if they continue.

This is crucial to patient safety, because what many patients don't realize, but is openly acknowledged in the drug and device industry, is that the first few years a new product is on the market is a crucial test of how safe the new drug or device really is. And keeping track of bad events is really important, but scarcely done well in the United States, at least up to now.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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