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Merck warned for not carrying out postmarketing study

Further safety study needed for diabetes drug Januvia

The US Food and Drug Administration (FDA) has delivered on its stated intent to clamp down on pharma companies who fail to meet postmarketing study commitments and sent a warning letter to Merck & Co for failing to carry out a safety study on its diabetes drug Januvia (sitagliptin).

The letter - addressed to Merck's global director of regulatory affairs Lou Ann Eader - notes that, as a condition of Januvia's approval, Merck had committed to carrying out a further three-month safety study of sitagliptin.

This study involves the use of the drug in a rodent model of diabetes to check whether it caused changes in the pancreas of the animals.

Failure to carry out the study within the agreed deadline of June 15, 2011, means that Januvia and related combination product Janumet (sitagliptin and metformin) are effectively misbranded.

The FDA said this was concerning "from a public health perspective" because the study was designed to "assess a signal of a serious risk of acute pancreatitis" with the drugs.

Labelling for Januvia and Janumet was updated in February 2009 to include a warning of the risk of acute pancreatitis, with the FDA saying at that time it had been advised of 88 cases since Januvia was first launched onto the market in 2006.

Merck could be fined $250,000 per offence, with additional civil penalties possible if it fails to address the situation promptly.

For its part, Merck has said it will carry out the missing study and will submit a protocol to the FDA within 30 days of the date of the warning letter (February 17). 

The company says that it did submit data from a 12-month study in mice that was intended to satisfy the postmarketing requirements (PMR), but in the letter the FDA insists this was not suitable and the company did not reach agreement with the agency that this was an appropriate substitute.

Pharma companies' failure to meet their PMR obligations has been an issue of contention for years.

For example, in 2009 a Government Accounting Office (GAO) report concluded that the FDA had to strengthen its oversight of these commitments after a survey suggested that in 50 per cent of accelerated drug approvals based on trials with surrogate endpoints, required postmarketing studies had not been carried out or reported satisfactorily.

29th February 2012

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