In social media, the old media rules apply, say experts, agencyPharmas spooked by the recent warning letter on an Adderall XR YouTube video shouldn't shy away from social media, according to industry regulatory experts.
In the case of the Adderall XR video, Shire says it was lifted from a company site and dumped on YouTube, where it appeared sans risk information. More intentional social media efforts continue to operate in a gray area, though.
“The reality is that we don't have specific guidelines, and they aren't coming soon,” explained Mark Gaydos, senior director US regulatory affairs, marketed products for Sanofi-Aventis, at ExL Pharma's Digital Pharma conference October 17. “If our customers are using social media – and they are – then we need to be there. I would argue that we have to make our own path in the meantime.”
An FDA spokesperson told MM&M that CDER associate director for safety policy and communication Paul Seligman is “not aware of any FDA position on the use of social media with regards to pharmaceutical promotion,” but that he would defer to DDMAC on the matter.” DDMAC, said a spokesperson, “has consistently taken the position that Internet promotion, like all other prescription drug promotion, must comply with the [Food, Drug and Cosmetic] Act and regulations -- there are not really specific ‘print regulations.' Rather, the Act and regulations apply to prescription drug promotional labeling and advertising in general, regardless of whether it is conveyed in print format or in some other format.”
The key, then, is in anticipating questions or concerns DDMAC may have, and being prepared to address them. According to Gaydos's colleague Craig Audet, VP, US regulatory affairs, marketing products at Sanofi, there are two major obstacles to online promotion: adverse events (AE) and off-label.
In most cases, blog-reported AEs are insufficient to identify safety signals and should not be submitted as AE reports, said Audet. Off-label discussions should be avoided on company sponsored websites, communities, KOL blogs and other media, but banner ads, for example, on independent sites where content isn't controlled by the advertiser, are not violative, said Gaydos. “The analogy would be a reprint of an ad in a journal [containing off-label product content].”