Life Science Compliance Update

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September 12, 2017

FDA Warns Cipher Over “Misleading” Marketing Materials

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The United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) sent a warning letter to Cipher Pharmaceuticals over promotional materials for its combination immediate- and extended-release opioid tramadol hydrochloride, ConZip.

The warning letter, addressed to Cipher President and CEO Robert Tessarolo, states that marketing materials for ConZip directed at healthcare providers are “false or misleading” because they omit “important risk information” regarding the use of ConZip and because of other “material facts.”

The FDA said the promotional materials for ConZip make claims about its efficacy, such as "All Day Pain Relief," but fail to mention any of its risks, which include addiction and the potential for abuse and life-threatening respiratory depression.

The FDA also notes that the materials do not communicate any information about risks associated with use of the product. The letter states, "by omitting the risks associated with ConZip, including serious and potentially fatal risks, the detail aid fails to provide material information about the consequences that may result from the use of the drug and creates a misleading impression about the drug's safety, a concern heightened by the serious public health impacts of opioid addiction, abuse and misuse.”

The FDA also says the promotional materials leave out important parts of ConZip's indication, which specifies that the drug should be reserved for patients for whom alternative treatment options, such as nonopioid analgesics or immediate-release opioids, are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient pain relief.

In the letter, the FDA requested the company: (1) stop distributing the promotional materials, (2) provide the agency with a list of all other materials that make similar representations of the drug, and (3) develop a plan of action to disseminate "truthful, non-misleading, and complete corrective messages about the issues discussed in this letter to the audience(s) that received the violative promotional materials,” on or before September 8, 2017.

The OPDP closed the letter by reminding the company,

The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for ConZip comply with each applicable requirement of the FD&C Act and FDA implementing regulations. Failure to correct the violations discussed above may result in FDA regulatory action, including seizure or injunction, without further notice.

After sending eleven warning letters last year, the OPDP only issued two so far in 2017. That would continue a years-long trend of declining activity since 51 letters were sent to drug makers in 2010.

Last year's total of eleven letters was boosted by a late-year burst of six letters that came in the month of December, so 2017 may still wind up matching the number of letters issued in 2016. As we’ve discussed before, the continuing drop in warning letters to industry may reflect a change in focus for the FDA.

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