FDA held a public meeting in April 2009 on the regulation of promotional speech on social media by medical product manufacturers and set the framework for the discussion (and the subsequent regulation) by asking five questions. Ostensibly guidance was to follow in short order, but in fact, many years passed before FDA issued guidance documents that only partially addressed the questions raised in that framework. The most comprehensive of these guidance documents were about correcting misinformation by third parties on the Internet and operating in platforms where there is character space limitation. Left unanswered were many questions such as issues related to adverse event reporting, among others.
The sluggishness of the agency is in many ways understandable. Digital media is fast evolving. Platforms develop rapidly and raise many new questions. Platforms also come and go. On the other hand, FDA’s process moves slowly and keeping up is difficult. Many times on this blog have I opined that moving from a system that is reliant on guidance development to something that operated more quickly, such as advisory committee on communications, might help speed things along.
But while digital health is exploding on many fronts and healthcare information abounds via social media, rather than speed up, it would seem in many ways that FDA is still focused on traditional communications vehicles when it comes to regulation from the Office of Prescription Drug Promotion (OPDP), per recent indicators.
First, the publication of the 2018 Guidance Agenda from the Center for Drug Evaluation and Research (CDER) has been posted to the CDER website and under the category of Advertising, there are only plans for two guidance documents, neither having to do with digital or social media (though presumably could include them as elements).
FDA is an evidence-based agency, both in terms of the products it reviews for approval as well as in the way it regulates. That brings us to the second indicator – the Office of Prescription Drug research agenda. There are currently listed 13 “Research in Progress” efforts going on. A number of them are focused on DTC advertising and two specifically are on television advertisements. Some are focused on Print ads and others are non-specific to print or broadcast. But there is only one that is involving digital/social – a project focused on character space limitation. Nothing on adverse events – nothing on optimizing a website for mobile.
A relatively recent research project undertaken and published by the agency looked at how DTC advertising in the form on landing pages for promotional websites treated drug benefits and risks when optimized for mobile and concluded that there were inconsistent approaches. The outcome is hardly surprising since FDA has provided no insight into its thinking on optimization for mobile or parameters for designing a landing page for an approved drug for mobile. FDA’s evidence based approach means that actual practice runs far ahead of critical FDA thinking, just as it did in 2009 when OPDP issued a slew of letters regarding banner ads to 14 companies for incorporating risk by link.
Comparing FDA’s pace in evolving the agency’s regulatory thinking regarding social and digital with the actual developments in these platforms shows a vast gap. Yet the uses and reliance on social media continues to go up. Unfortunately, judging from what is visible with FDA’s plans as made public through future guidance development or research in process indicates that this gap will be narrowing any time soon.
For an overview of milestones related to FDA and social media, check out the tab on the Eye on FDA blog.
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I suspect that there won’t be any additional progress on social media until the one-click research is completed. See here for last update from FDA on that: https://www.regulations.gov/document?D=FDA-2016-N-3585-0014 One of the most challenging aspects of use of social media is the constraints on posted content. These constraints are not typically as clear cut as FDA’s guidance on character-space-limited posts made it appear, so applying the principles from that guidance to actual practice can be challenging.
Dale – I suspect you are right, but there are other areas that were left unanswered, such as adverse events, that have little or nothing to do with space limitation. Thanks, Mark