Merck (NYSE:MRK) has received a warning letter from U.S. regulators after failing to conduct a post-marketing study for its blockbuster diabetes drugs Januvia and Janumet within a previously agreed timetable.
The U.S. Food and Drug Administration said the drugmaker failed to conduct a three-month pancreatic safety study in a rodent with diabetes that was treated with sitagliptin, the active ingredient in Januvia and Janumet, and report the results by June 15, 2011, according to the letter published on the FDA’s website.
The letter highlighted a lengthy time line of correspondence between the Whitehouse Station, New Jersey pharmaceutical company and the U.S. regulator over the issue.
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Although Merck submitted data from the independent rodent study, once it had carried it out, it was not sufficient, the FDA letter said.
Merck has been given 30 days to submit a final study protocol for another three-month safety study on rodents and to initiate the test within the next six months, or face regulatory action that could lead to a fine of at least $250,000.
Januvia and Janumet are among Merck’s blockbuster drugs. In the 12 months through Dec. 31, 2011, Januvia had $3.3 billion in sales and Janumet had $1.3 billion in sales, according to its earnings report. Worldwide sales for both drugs rose 40 percent in 2011 over the previous year.
In a statement on its website, Merck said it takes its responsibility to comply with FDA regulations very seriously and is thoroughly reviewing its processes and procedures to ensure that Merck fulfills its commitments to the FDA going forward.
