Regulatory Focus™ > News Articles > Untitled to Letter to Shionogi Threatens to Revoke Marketing Clearance for Painkiller

Untitled to Letter to Shionogi Threatens to Revoke Marketing Clearance for Painkiller

Posted 23 May 2013 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) has sent a rare Untitled Letter to pharmaceutical manufacturer Shionogi for the alleged failure of the company to comply with the terms of the mandatory postmarketing commitments for the company's drug Rybix ODT, a painkiller, raising the prospect that the drug could soon be forced off the market.

The Untitled Letter references a letter FDA sent to Shionogi in 2010 requiring the company to conduct two postmarketing studies to assess the risk of QT prolongation, which had been identified as a potentially serious and unexpected risk associated with the drug.

One of those studies required the company to have submitted a draft protocol submission by February 2013, and a final protocol submission in May 2013.

Does Not Intend to Comply

However, the company wrote to FDA in November 2012, stating that it did not intent to comply with those trials due to their prohibitive cost relative to the drug's annual sales, FDA recounted. Instead, FDA said the company proposed an alternative scenario whereby it would be permitted to continue to sell the remainder of its existing stock through September 2013, after which time it would cease marketing of the drug.

FDA, however, has refused the company's bid for an exemption, saying failure to complete the postmarketing study requirements (PMRs) will render the drugs misbranded if it does not submit a final protocol to the agency by the end of May.

"Furthermore, FDA has determined that you have failed to demonstrate good cause for missing the February 2013 milestone date," it added. That lack of "good cause" would violate section 502(z) of the Federal Food, Drug and Cosmetic Act, FDA explained.

If the drug is found to be misbranded, it would be forced off the market, and would otherwise be subject to seizure and civil money penalties under federal law.

The Untitled Letter is the only such one referencing unfulfilled postmarketing study requirements listed on FDA's website in at least the last five years, according to the agency's website.


FDA Untitled Letter to Shionogi


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