The FDA issued last month a draft guidance on “Regulatory Requirements for Postmarketing Submissions to the FDA of Interactive Promotional Materials.” In other words, it’s a draft guidance on which of the materials that a company intends to use on social media and similar platforms should be filed with the FDA and how and when to do so. The draft guidance doesn’t address the FDA’s thinking on what constitutes proper or improper promotion on those platforms. That, we expect, is coming soon.
Here are some highlights. A company is responsible for promotional sites that it owns, controls, created or influences. If the company creates an interactive product web-site, it should file with the FDA not only copies of pages of the static website but also annotations describing the interactive portions. If the company places promotional material on a third-party site, it should file that promotional material with the FDA. If it has any control or influence over how the third-party displays that promotional material, it should also file surrounding pages of the third-party site to give context. Employee comments about a product, say by sales reps, should be filed with the FDA. The entire blog of paid bloggers should also be filed. The FDA should be updated if if there’s a change to a company site, by filing (and if necessary describing) only the changes. Every month, the company should file an update that lists all sites on which it remains active. It needn’t include screenshots of its participation. If the company stops participating in any of these sites, it should inform the FDA that day. There’s more. You should refer to the draft guidance itself if you want to consider all of it.
What’s still missing, though, is guidance on how promotional material can be presented on social and other interactive media in a way that satisfies the FDA. There are hints. While companies are responsible for material on sites that they control, create, operate or influence, the FDA suggests that it would not hold them responsible for the content of sites for which they provided financing but over which they exercise no control or influence (e.g., via an educational grant). Also, the FDA suggests that it will not hold the company responsible for user-created comments, even on company-operated sites, if those user comments are truly independent, meaning that the company has no affiliation with the user and exerted no influence over the comment. That’s a helpful concept. But there’s a lot to be filled in.
It seems that the FDA knows that. As most of you know, over four years ago, the FDA held a two-day Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools. The FDA has since updated the webpage dedicated to that hearing, and the updates include a statement by the FDA that it has developed guidance concepts that it is committed to addressing:
FDA has obtained significant input from within and outside FDA, including testimony and comments from the Part 15 hearing on the use of Internet/social media for promotion of FDA-regulated medical products. We have developed a variety of guidance concepts including: how companies should respond to unsolicited requests for information about off-label use, issues with space limitations, fulfilling post-marketing submission requirements, accountability, use of links on the Internet, and how sponsors should correct misinformation about their products disseminated by third parties. Despite our limited resources and increasing workload, OPDP remains committed to providing guidance and clarification to industry in this area in terms of both Agency time and human resources.
(Emphasis added.) And, as we’ve blogged about before, the Director of the FDA Office of Prescription Drug Promotion, Thomas W. Abrams, has publicly stated that the development of guidance on these issues is amongst the FDA’s highest priorities.
To date, though, FDA hasn’t issued guidance on many of these issues. It issued the one we’ve discussed today, and in December 2011 it issued a draft guidance that addresses, amongst other things, unsolicited requests for off-label information through company and third-party websites.
But, as the FDA itself has admitted, there’s a lot left. And the clock is still ticking. Congress gave the FDA until July 9th of this year, which is fast approaching.