FDA Hosts Webinar Addressing Social Media Draft Guidance

The Food and Drug Administration hosted a Social Media Draft Guidance Webinar. The July 10 webinar included summary review of the three draft guidances issued this year to date followed by a brief Q&A. Thomas Abrams, director of the Office of Prescription Drug Promotion and the Center for Drug Evaluation and Research, set the stage by commenting, "Ongoing changes in technology have transformed the ways patients and health care professionals learn about medicine." As always, however, the heart of FDA's recommendations stem from its position, articulated in the webinar by Jean-Ah Kang, special assistant in the Director's Office of OPDP, that "regardless of the platform, truthful, accurate, and balanced product promotion best serves the public." During the webinar, FDA was not able to provide an estimate for finalization of the guidances. For those who missed it or were unable to connect due to technical difficulties with the webcast, here are some highlights:

Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics (Draft Guidance)

• Barbara Chong of OPDP provided clarification on the scope of the guidance, saying, "This particular guidance does not apply to reminder promotions. ... There is a footnote within the guidance."
• For sites that are not restricted, such as by subscription or password, FDA does not need screen shots or other visual content to be submitted. "However, that is not the case for restricted sites because the FDA does not have access to the site whether it is password protected or a password is required. If that is the case, all content related to the discussion should be batched and submitted monthly to adequately provide context to facilitate the FDA's review."
• Ms. Chong said, "Again, let me reiterate that these recommendations are limited to interactive promotional media and that nothing has changed for the submission of static sites."

Internet/Social Media Platforms with Character Space Limitations - Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (Draft Guidance)

• Offering little compromise to industry, Jean-Ah Kang of OPDP said, "A quick overview of our policy with regard to the specific guidance topic: regardless of character space constraints that may be present on certain Internet and social media platforms, if a firm chooses to make a product benefit claim, the firm should also incorporate risk information within the same character-space-limited medium."
• Ms. Kang gave a later clarification on the topic of "www.product.com/risk," saying, "a link to PI or brief summary would not suffice in place of disclosing risk information within the communication itself if that communication contained claims of benefit."
• The only ground that FDA seems to intend to give regarding character-space-limited communications is in allowing the exclusion of dose information as long as it is present on the landing page of all included hyperlinks.
• When questioned about the guidance's applicability to mobile device limitations, Ms. Kang responded, "The draft guidance does not address technology-specific layout features that would result in product promotion recitations that may differ depending on the device used to view them - in this question, how you see something on a mobile device. Just remember, the scope of this draft guidance is specific to Internet social media platforms that impose character space limitations, the emphasis being on the word 'character.' We believe something such as a mobile device does not impose character space limitations, and that would be outside the scope of this guidance."

Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices (Draft Guidance)

• Julie Chronis, J.D., of OPDP, said, "Positive or negative, I want to emphasize that the correction of misinformation is a voluntary activity."
• The point was also emphasized that "FDA does not intend to object if appropriate corrective information does not satisfy otherwise applicable regulatory requirements regarding labeling or advertising (if any)."
• Two questions arose regarding FDA's policy overview statements above: "Is it really appropriate for companies to correct misinformation by a third party?" and "Is this corrected information subject to the label requirements of the act?"
• Ms. Chronis remarked, "A firm is responsible for the content generated by an employee or agent who is acting on behalf of the firm to promote the firm's project. ... A firm is generally not responsible for user-generated content that is truly independent of the firm. That is key: not produced by or prompted by the firm in any way." This led to the question of whether FDA considers the mere creation of a social media page to qualify as "prompting." Ms. Chronis responded, "The answer is no; the mere creation of a social media page generally would not be considered prompting. However, if a firm triggers a response by its actions, the firm may have prompted a response. So of course everything would be determined on a case-by-case basis."

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