Omitting risk info in ads is top reason for FDA warning



About 60% of FDA warning letters and untitled letters issued to pharmaceutical companies over the past two years cited omitted risk information in promotional materials, according to Johnson & Johnson executives presenting at Digital Pharma East.


Sheetal Patel, J&J's director of regulatory advertising and promotion, and John Riehl, a regulatory advertising and promotion fellow at the company, on Tuesday presented an analysis of FDA warning letters and untitled letters issued by the FDA's Office of Prescription Drug Promotion from 2013 to 2015. The Digital Pharma East conference is being held in Philadelphia.


The FDA issues fewer warning letters, which require corrective action by the company, than untitled letters, which are for less serious violations and usually request, rather than require, a response from the company in question. An untitled letter is also called a notice of violation.


From 2013 to 2015 the regulator issued 37 untitled letters and 6 warning letters to pharmaceutical companies. The FDA's most recent warning letter became front-page news after the agency warned Duchesnay that Kim Kardashian West's promotion of Diclegis, a morning-sickness drug marketed by the company, violated FDA rules because she omitted information about the drug's risks. Kardashian later issued corrective posts on Twitter, Instagram and Facebook.


While 25 of the FDA's promotion actions during this period were for print materials, there were 19 warning or untitled letters for digital, social media or mobile promotional activities.


Several years ago an analysis found that the FDA is more likely to send a warning to a drugmaker if the marketed therapy has a black-box warning. The analysis was conducted in 2013 by FleishmanHillard's Mark Senak, who blogs at Eye on FDA.


The pharma industry has argued for years that the FDA's regulations for social media are outdated and limit the industry's use of new channels for drug promotion and education. The FDA has since issued guidance for Twitter and paid search. Still, Jack Scannelli, head of regulatory advertising and promotion at Novartis, who shared the stage with Patel and Riehl at Digital Pharma East, said he doesn't expect the FDA to issue guidance for each social-media channel.


“By the time they come out with a guidance on a certain platform, it may be totally useless,” he said. “They are more concerned about staying power.”