Some Lessons Learned from 2011 Warning Letters

Some Lessons Learned from 2011 Warning Letters

August 17th, 2011 // 12:55 pm @

Earlier this week, we examined the Warning letters that came from FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC). Today we’re going to look at a few of the communications lessons learned from same – and reminding us that when in doubt, consult legal and regulatory resources.

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Risk Information – The minimization or omission of risk information from promotional materials continues to be the perennial favorite violation cited by DDMAC. Ironically, one would think it the area with the least subtlety associated with it – unlike statements associated with a broadening of indication where there can be some judgement calls involved. In fact, there are instances where a drug name is used, the indication if not directly stated, is implied from portrayal, and yet absolutely no risk information is included. Another example that is often repeated is the notion of incorporating risk information by reference – i.e., after a great deal of space goes to discussing the indication and benefits of a product, language is then used which send the reader to a website for further information (which is where the risk information is). Three part lesson – always include risk information; do not abbreviate and incorporate the balance by reference; and the one involving the most judgement – do not present it out of balance with claims of the indication – i.e., in small black and white print at the bottom of a print ad or the very end of a video. And of course, always consult legal.
Promotion of Unapproved Drug – On the other end of the spectrum, it is a relatively uncommon for a company to receive a regulatory action letter about the promotion of an unapproved drug, but have been two examples this past quarter. The first involved an investigational drug that had received a Complete Response Letter from the FDA. Despite that fact, there existed a brochure that contained in the title the words “New therapies…”along with statements as to how the treatment worked and positioning the investigational compound as a “valuable option for treating patients”. The agency stated that taken it is totality, this suggested that the investigational drug was safe and effective. The second example involved the content on a website that was deemed to have been promoting an investigational product. Here, in discussing the pipeline – the language read that the treatment had “demonstrated both safety and clinical efficacy” that it was safe, and that it was well tolerated. – Communicators note that until a drug has been approved (not only been before an advisory committee) the safety or efficacy of a drug should not be concluded or suggested by language. It is not safe or effective until an approval letter from FDA is in hand. Once conclusions are put forward about data, then one may be going outside the boundary of exchanging scientific information about a product into the territory of promotion.

Sometimes the issues are obvious – include risk information. Sometimes they are more nuanced. Particularly for the latter circumstance, that is why getting legal and regulatory examination is so important.

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