Greed and Post-Marketing Requirements Lead to Trouble for Shionogi

Greed and Post-Marketing Requirements Lead to Trouble for Shionogi

May 29th, 2013 // 12:50 pm @

Latest FDA and cGMP Compliance News

FDA told Shionogi that two clinical trials would be needed after it was found that there was a big risk of heart arrhythmia  with the painkiller Rybix. FDA also told Shionogi that a draft protocol was needed in Feb. of this year and a final report would be needed by Sept. 2014.

In November, Shionogi told FDA ‘no thanks.’ The firm wrote FDA that the costs of the post marketing requirements were not justifiable due to the low sales potential of the drug. Of course, patients had been harmed, but Shionogi did not want to spend the money to see what the problem was.

But wait, there’s more! Rather than withdrawing the product right away, Shionogi asked the agency if existing stock could be sold! So, the company wanted to two ways – forget the clinical study and also sell down existing inventory – at the expense of consumers/patients.

We would argue that these actions would not exactly be in line with the mission of the company, which is supposedly to ‘work to deliver a better life.’ It looks like the company wanted to work for more profits in this case.

FDA often slams companies for post marketing requirement problems. The problem is that drugmakers often do not want to pursue essential safety studies, but still want to make money by selling the drug. For example, in 2012, FDA stated that two drugs sold by Merck – Januvia and Janumet – were misbranded because Merck did not turn in post-marketing studies, which FDA had mandated to look at the risk of pancreatitis.

Usually, FDA does track how well companies adhere to post-marketing requirements. In 2008, the Food and Drug Administration Amendments Act authorized FDA to mandate that drugmakers do postmarketing tests to assess any known serious risks or safety signals. There are two types of studies – required post marketing studies and studies that the company volunteers to do.

In the case of Shionogi, FDA came down hard. FDA told the company that it has obligations on the post marketing side until the agency gets a request to withdraw the marketing app for a drug. So, Shionogi now faces fines for not providing a good cause for not pursuing the required studies.

Shionogi may be reconsidering this decision, as there was a letter issued by the company May 10 that suggested it would turn in a protocol in 30 days.


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