Most marketers are familiar with the process of submitting for FDA review their advertising and promotional materials. What’s not quite so apparent is how the review process works once FDA receives each submission.
Tom Abrams, the director of the Office of Prescription Drug Promotion (OPDP) at FDA, explained some of the inner workings of his review group earlier this month in a Q&A interview with one of the FDA’s blogs.
Among the noteworthy aspects of the interview, Abrams explained that the agency receives “anywhere from 6,000-8,000 pieces of advertising and promotional submissions each month,” and that these materials are then parceled out to one of 32 reviewers based on specific drug categories.
Not surprisingly, Abrams noted that the Internet and the proliferation of social media has made the FDA’s job more difficult by increasing “the volume and extent of materials and speeded the delivery of those materials. Websites can have hundreds of pages and can change daily.”
Abrams did not discuss a timetable for issuing the long-awaited guidance on social media, but he did acknowledge that the agency “generally” does not have “authority over statements made by independent organizations or persons—what we call third parties—unless they are acting on behalf of a company” – something that can be more commonplace with the rise of social media and the growing interest in health and wellness.
The bottom line, as expected, is that marketers must continually be vigilant in monitoring their own promotional efforts, steering clear of any content that minimizes risks or overstates benefits – the two most-often cited promotional violations.