FDA Guidance for Industry: Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics

Jan. 13, 2014: At long last, the US Food and Drug Administration (FDA) has released social media guidance for pharmaceutical and biologic manufacturers. Policy and Medicine has been following this issue for a while now, most recently reporting that the Food and Drug Administration Safety and Innovation Act (FDASIA) mandates that FDA issue final social media guidance no later than July 2014.

As a background, the FDA tightly regulates pharmaceutical advertising, and currently companies are required to submit to the FDA every promotional document—including printed, television, and website advertisements—at the “time of initial dissemination.” Companies must submit promotional activity for a particular drug product on Form FDA-2253. Furthermore, each ad must contain a variety of elements, such as cited evidence for all claims, a “fair balance” of the benefits and risks of the drug, and any Black Box warnings.

With the rapid increase of promotion through real-time social media outlets, pharmaceutical companies have wondered how to properly follow the regulations in the digital age. Promotions via tweet or Facebook post, for example, can be uploaded instantly, in large quantities, and, on Twitter at least, in a maximum 140 characters. Many stakeholders worried that the FDA would require companies to submit “interactive promotional material” as if it were a traditional printed advertisement. Should a company have to submit real-time reports for every tweet or Linkedin message it sends out? This would not only be impossible for some social media advertising (and highly burdensome for the rest), but the FDA would have to work around the clock to process each submitted social media post.

Monday’s draft guidance cleared up some of the confusion. Entitled Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics, the guidance describes what companies must report, and how they can submit their materials to FDA for review. The FDA wisely acknowledged that interactive media often possess “unique technological features and offer novel presentation and content features that set them apart from print.” The guidance provided that “interactive promotional media” includes modern tools and technologies that often allow for real-time communications and interactions (e.g., blogs, microblogs, social networking sites, online communities, and live podcasts) that firms use to promote their drugs.

What must companies submit to the FDA?

The guidance states that any material posted to a social media site controlled either directly or indirectly by a firm, must be submitted to FDA’s Office of Prescription Drug Promotion (OPDP). FDA provided examples of influence: editorial control, preview or review privilege, or collaboration with the poster of the information. FDA’s definition of “control” extends to company employees acting on behalf of the company, such as a company-directed tweet from an employee’s private account. Furthermore, according to the FDA, “[i]f a firm has any control of, or influence on, the third-party site, even if limited in scope, it is responsible for submission to FDA to meet the postmarketing submission requirements.”

However, the FDA included important qualifications: if one company has given another unrestricted grant money, but otherwise contains no interest in posted materials, then those posted materials do not necessarily have to be submitted. Furthermore, if a firm is “merely providing promotional materials to a third-party site but does not direct the placement of the promotion within the site and has no other control or influence on that site,” that firm is responsible only for submitting to FDA promotional content that was disseminated on that site.

The FDA also revealed its implementation strategy, stating it intends to “exercise its enforcement discretion under certain circumstances due to the high volume of information that may be posted within short periods of time using interactive promotional media that allow for real-time communications.”

John Kamp, Executive Director of the Coalition for Healthcare Communication, found the FDA’s guidance a bit slight in content, but nonetheless helpful for many industry stakeholders:

Many in the industry are looking forward to more guidance on similar issues, but this is a great step forward. One prominent advance is that the guidance provides clarity on the question of when a regulated company has responsibility for the content of social media sites, and — even more important — when it does not have responsibility. This alone clears the air on an issue that has caused many companies to be reluctant to even advertise on third party sites containing blogs, open fora, chat rooms and the like.

At the same time, it’s good that FDA has decided to use enforcement discretion to enable companies to file monthly on changes on the social media sites. A strict reading of the rule would have them filing every time there is a new entry.  That saves the government and the industry time and money.

As Mr. Kamp indicates, the FDA’s rule states that once every month, a firm should submit an updated listing of all non-restricted sites for which it is responsible or in which it remains an active participant and that include interactive or real-time communications. Firms need not submit screenshots or other visual representations of the actual interactive or real-time communications with the monthly updates.

Bullet points of companies’ responsibilites:

• Companies are responsible for product promotion on sites that are owned, controlled, created, influenced, or operated by, or on behalf of, that company. Such product promotion may include company-sponsored microblogs (eg Twitter), social networking sites (eg Facebook) and the company’s blogs. 
• Under certain circumstances, companies are responsible for promotion on third-party sites: Companies are responsible for such promotion if they have any control or influence on the third-party site, even if that influence is limited in scope
• Companies are responsible for the content generated by an agent or employee who is acting on behalf of the firm to promote the firm’s product.
  
• Companies are NOT responsible if they merely provide promotional materials to a third-party site, but do not direct the placement of the promotion within the site and has no other control or influence on that site. The company would only be responsible for submitting to FDA promotional content that was disseminated on that site.

The FDA’s draft guidance clears up some questions, but pharmaceutical companies promoting their products through social media have a lot to monitor, from employees to third party actors. Above all, FDA encourages companies to “be transparent in disclosing its involvement on a site by clearly identifying the user-generated content (UGC) and communications of its employees or third parties acting on behalf of the firm.” Such an expectation can be tough in the social media context.

Stay tuned to Policy and Medicine for more updates in this evolving landscape.

Submit Comments

Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. We estimate this to be April 13, 2014.

Submit electronic comments to http://www.regulations.gov.

Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.