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Merck’s Postmarketing Study Delays Prompt FDA To Unsheathe New Enforcement Power

 
• By Brenda Sandburg

Januvia and Janumet are misbranded, FDA tells Merck in a warning letter noting that rodent safety studies for the sitagliptin diabetes drugs were 20 months behind schedule. The letter marks the first time FDA has used its FDAAA powers to take enforcement action against a pharma company for such a delay.

Wielding its new power to enforce postmarket study requirements, FDA sent Merck & Co. Inc. a warning letter for missing a deadline to complete a postmarketing study of Januvia (sitagliptin) and Janumet (sitagliptin/metformin) by more than 20 months.

In a Feb. 17 letter

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