Uh, Oh, someone is in trouble!
Drug maker, Merck & Co., may be facing fines over how it conducted diabetes drug studies for Januvia and Janumet, after being almost a year late with a post-market study of it’s the diabetes drugs to determine if the pills inflame the pancreas, U.S. regulators said.
According to a letter posted on the Food and Drug Administration’s website, the letter 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.
Januvia and Janumet work to lower blood sugar levels in patients with Type 2 diabetes. Approved in 2006, Januvia was soon linked to reports of patients suffering from inflamed pancreas, said Reuters. The FDA asked Merck to study the link to determine if the drug was causing the problem. Janumet is a combination of sitagliptin and metformin, and is a an older medication that helps to control blood sugar levels, said Reuters.
The FDA had already revised prescribing information for Januvia and Janumet, 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.
Merck had previously agreed to conduct a post-approval study of the drugs in mice to determine if the drugs increase risks for acute pancreatitis, according to the agency’s warning letter, dated February 17. They had agreed to complete the study by March 15, 2011.
The agency can mandate companies to conduct additional drug trials following approval to resolve safety issues. Failure to comply with the FDA’s request can lead to fines of up to $250,000. “Your product is considered misbranded because you are in violation of a post-marketing requirement,” wrote Leslie Ball, acting director of the FDA’s office of scientific investigations, in the letter to Merck, said Reuters. “You have failed to comply with the approved timetable … and failed to show good cause for not conducting the additional testing required,” Ball added.
Although Merck argued that people with diabetes are likelier to develop pancreatitis, it did agree to conduct a three-month test, said the FDA, but only after it was supposed to have submitted a report on the matter last year. Its study design was to be to the agency by June 15, 2010 and its final report by June 15, 2011, Reuters noted. The drug maker never submitted a study design, saying it would rely on an independent study to review safety, although the FDA did not agree to this plan, the agency said.
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 fines against Merck may total $250,000 with the possibility of additional penalties if the violation continues.