What Happened. This week FDA issued a new final guidance related to communications about medical products that, while representing a slight liberalization of regulation when it comes to discussing useful information about a drug and the cleared uses for it, but which may not be included in the label. That said, the guidance does not address the issue of off-label promotions – or discussions that involve aspects of the product for uses in which it has not been cleared. The utility of the new guidance is that it will allow firms to talk about things – such as post-marketing study outcomes – that will enhance the understanding of the on-label use of the product.
What it Says. To shed light on where the parameters are, the guidance document provides eleven Q&A format discussions to demonstrate the approach that FDA is taking. The first Q of the Q&A covers which products are addressed and the second provides the crux the regulatory approach in answering how FDA determines whether a communication is consistent with the FDA-required labeling. The agency said that it uses three factors to determine compliance and failure to meet any of them results in a communication that is outside of the FDA-required labeling. The first such factor involves the actual information contained in the communication – whether it varies the indication, the patient population, affects the limitations and directions for use and whether it alters the dosing or use regimen. If the answer to any of these is yes – then the communication is not going to be consistent with the label. The other two factors are a bit less objective. The second of the three factors is whether the communications increase the potential for harm and the third factor is whether the directions for use enable safe and effective use under conditions that may be described in the context of the communication in question.
The balance of the guidance provide specific examples to more sharply define the parameters of how the agency applies the assessment of a communication by the company that is about information not included in the label, but which is not involving an off-label use.
Implications and Insights for Pharma. In considering how the new guidance may impact the communications by pharma companies, it is important to take into account where violations have occurred in the past. It is notable that FDA has issued this guidance during a time when enforcement by the agency is at a standstill with only a single enforcement letter having been issued by the Office of Prescription Drug Promotion (OPDP) so far during 2018 and following a record low of 6 last year. In reviewing FDA enforcement since 2004, out of the 324 letters issued by OPDP (or under its predecessor name DDMAC – the Division of Drug, Marketing, Advertising and Communications) by my count only 18 letters involved a violation of promotion of an unapproved use. Of those, 7 involved oral statements, mostly by sales representatives, though one involved a company CEO in a media interview. Other violations almost exclusively involved communications vehicles aimed primarily at physicians, such as Dear Doctor letters, direct mail or sales aids. So while the new guidance pertains to all communications by companies to physicians, because the most common violation occurred in the contest of an oral statement, particular care might be taken by companies to train spokespeople with regard to the parameters of the new guidance, especially for sales people who visit doctor offices or who are speaking with people at medical meetings while staffing exhibit booths.