The Office of Prescription Drug Promotion (OPDP) and its Advertising and Promotional Labeling Branch (APLB) of the US Food and Drug Administration (FDA) have been busy. Over the past year, they have released multiple guidances, expanded the so-called "bad ad" program that asks healthcare professionals to police inappropriate promotional efforts, and issued a number of untitled and Warning Letters.
During a panel discussion at 2012 RAPS: The Regulatory Convergence, regulatory professionals discussed the various ways drugmakers' missteps, small and large, could result in FDA enforcement actions against questionable promotional activities. The consequences for doing the wrong thing are severe, but guidance from FDA has been spotty, said Dale Cook of Digitas Health and Razorfish Health, who moderated the panel and served as the session leader. Glenn Byrd of MedImmune LLC and Sue Duvall of Amgen also participated.
With more pharmaceutical companies engaging in disease education efforts, in addition to communications that are more clearly marketing, where the line between the two is drawn is critical.
The distinction is not always clear, said Byrd. "What's bottom line?" he asks. Regulatory professionals sometimes are in the position of having to interpret the intent. "I want to educate about disease, but how do I connect to the things that are more relative to the company?" asked Byrd, conveying a common concern among regulatory professionals working with pharmaceuticals.
"The question I always ask myself is, after going through this disease education, does it drive me to a specific treatment?" said Duvall.
Disease education must be consistent with product labeling, said Byrd, but he expressed concern that because of this, companies could potentially mis-educate patients because any information related to unapproved indications must be omitted.
Panelists emphasized the importance of communicating with other departments within a company, including marketing, communications, medical affairs and the clinical recruitment team.
Functional and aesthetic aspects of communications must be considered. For example, a disease education website must not only be clearly separate from any branded online properties, it can't have similar colors or features that in any way could cause the two to be confused, said Byrd. It must have a completely different look and feel.
When it comes to social media, many drugmakers are hesitant because of the concern that they will become responsible for content they cannot control, or be seen as endorsing off-label uses discussed by patients.
FDA is clear that drugmakers cannot talk about off-label uses, said Byrd, but of course doctors and patients can request information, and companies may respond narrowly to the specific request. But what if a request is made via social media or another public forum, where one person may have posed the question, but it the group may now be anticipating a response?
To this and other gray area promotions questions, "Our marketing colleagues really want a black and white answer from us, and we don't have one," said Duvall.
Clinical recruitment efforts, too, may cross the line into violating FDA rules. "You can't promise anything being safe and effective until it's approved," said Byrd, who also pointed out that by implying some sort of result, trial recruiters could actually jeopardize the results of the study.
Sometimes, the regulatory promotions group may not be involved at all in clinical trial recruitment, and may only be brought in if there is an enforcement action. But they should be involved, Byrd and Duvall agreed.
Byrd reiterated the importance of developing working relationships with internal cross-functional partners. Typically, he said, they're doing a good job but may need some very subtle changes, and in the case of Byrd's own clinical colleagues at MedImmune, he said they were very receptive to his team's suggestions.