Merck & Co. (MRK) may face fines after being almost a year late with a post-market study of its diabetes drugs Januvia and Janumet to determine if the pills inflame the pancreas, U.S. regulators said.
A letter posted today on the Food and Drug Administration’s website warned a subsidiary of the Whitehouse Station, New Jersey-based company that the diabetes medications are considered misbranded because Merck hasn’t completed a 3-month pancreatic safety study in rodents. Merck agreed to the study to gain expanded approval of the drugs and committed to completing it by March 15, 2011, according to the letter dated Feb. 17.
Merck will submit a design for a study to the FDA within 30 days of the date of the letter and start the trial within six months of the agency’s agreement on a protocol, Merck spokeswoman Pamela Eisele said. The company attempted to submit a 12-month independent study to the FDA to satisfy the post- market requirement, and the agency determined the data was insufficient, according to the letter.
“This violation is concerning from a public health perspective,” because the additional testing is to assess “a signal of a serious risk of acute pancreatitis, including necrotizing forms, associated with sitagliptin,” the main ingredient in both medicines, the letter states.
The FDA revised prescribing information for Januvia and Janumet, Merck’s drug that combines Januvia with diabetes treatment metformin, in 2009 to include information on reported cases of acute pancreatitis. The agency received 88 cases of acute pancreatitis between Oct. 16, 2006 and Feb. 9, 2009 associated with sitagliptin, the first in a new class of diabetic drugs.
The fines against Merck may total $250,000 with the possibility of additional penalties if the violation continues.
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