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FDA threatens Merck with fine for failing to submit Januvia, Janumet safety study

Filed March 1st, 2012 Joshua Sophy

The Food and Drug Administration has threatened pharmaceutical giant Merck & Co. for not submitting the results of post-market safety reviews of its diabetes drugs Januvia and Janumet by an agreed-upon deadline.

According to a Reuters report, Merck had until June 15 last year to submit the results of post-markets studies investigating the allegations that Januvia and/or Janumet increased the likelihood a person would experience an inflamed pancreas. Just under two weeks ago, the FDA posted its letter to Merck on its Web site which indicated the agency was ready to fine the company for failing to adhere to a deadline on that study.

The FDA can order a drug maker to conduct a post-market safety review of a new or old drug if it’s believed that drug may be causing severe side effects. Merck agreed to the FDA’s order last year, saying it would test for the cause-and-effect relationship between its diabetes drugs and acute pancreatitis in lab mice. The sides agreed the review should be completed last June and since then, Merck continues to miss one new deadline after another in producing this report.

In the letter posted online, the FDA indicates it can impose a $250,000 fine if the deadline is missed again, charging the company wasn’t complying disclosure requirements. Additionally, the FDA does not appear to be open to excuses from Merck at this point, noting its letter the drug company has “failed to show good cause for not conducting the additional testing required.”

The FDA’s order to produce post-market safety testing on Januvia and Janumet was sparked by a consistent stream of reports of people suffering pancreas inflammation after beginning these drugs in attempt to lower blood sugar levels in the fight against diabetes.

Merck has dodged efforts to get these tests completed and has yet to submit its plan for testing these drugs for the side effects in question. The company said, despite agreeing to do as the agency said in doing a “study design” report, it would just rely on independent testing of the drugs to submit to the FDA.

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