FDA Draft Guidance Addresses Postmarket Submission of Online Promotional Material

Jan. 14, 2014 – The determining factor regarding whether a firm submits online prescription drug promotional material to the agency is “whether the firm or anyone acting on its behalf is influencing or controlling the product promotional activity or communication in whole or part,” according to a recent FDA Draft Guidance, “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.”

The FDA asserts in the Jan. 13 draft guidance that if a firm has any control of, or influence on, a third-party site, even if limited in scope, it is responsible for submitting materials on that site to FDA to meet postmarketing submission requirements.

The new guidance provides industry with a long-awaited glimpse of where the FDA is heading with its social media strategy. “Overall, this guidance represents a very measured approach to applying FDA regulation to online promotion,” said Dale Cooke, Vice President/Group Director, Regulatory Review, Digitas Health. “It moves the ball forward significantly for sponsors of prescription products who were concerned about how they could meet these regulatory requirements in time-sensitive channels.”

Cooke told the Coalition for Healthcare Communication that there are two extremely positive developments in the draft guidance. “I am not sure which is better. The first is that FDA is acknowledging that social media and the Internet differ sufficiently in key ways that require FDA to adjust its traditional regulatory framework to accommodate those differences,” he said.

He remarked that in Section V of the document (Recommendations for Submitting Interactive Promotional Media), the FDA “is taking a very reasonable approach to regulations that were originally written for a largely print-focused world and applying them to a digital world that shares many features in common with print, but also has its own unique characteristics.”

That change is “a major milestone for FDA, and it’s extremely welcome,” Cooke said. “Almost as good, or maybe better … is that FDA officially endorsed in print the commonsense view that makers of prescription products will not be held accountable for the user generated content [UGC] that people completely unaffiliated with the companies post.”

Although this “might seem like a trivial point,” Cooke said that he has heard people in industry repeatedly voice a fear that FDA would take the position that if a firm owns the venue (Website, chat board, etc.), then it is responsible for any conversation that takes place inside it, even if it did not create, influence, or endorse the conversation.

Specifically, the guidance makes clear that if a firm owns, controls, creates, influences or operates sites on which it places promotional communications for its drugs, that firm is responsible for submitting those materials to the agency via FDA Form 2253.  The document also states that under certain circumstances – when it collaborates or has editorial, preview or review privilege – a firm is responsible for promotion on third-party sites as well. For example, if a firm makes suggestions on the placement of its promotional messages on an independent third-party site, it is the FDA’s position that the firm is responsible for submitting to the FDA the promotion, along with the surrounding pages, “to adequately provide context to facilitate the review of the third-party site, in order to fulfill the postmarketing submission requirements.”

Firms that provide only financial support, e.g., through an unrestricted grant, and which have no control or influence on a site, are not responsible for information on that site or for submitting content to the FDA. However, a firm is responsible for any content generated by an employee or agent who is acting on behalf of the firm to promote the firm’s product. Employees or agents include medical science liaisons, paid speakers/key opinion leaders, and bloggers acting on behalf of the firm.  

One point that needs further clarification, in Cooke’s view, is what responsibility sponsors are taking on when they submit materials under a Form 2253, a practice that is significantly expanded under this guidance. “Normally a sponsor views anything that it submits to FDA via that Form as being content that it owns and is taking responsibility for,” Cooke explained, “yet the FDA appears to be requiring that even if a sponsor has done nothing more than reviewed a particular online venue to see whether it’s an appropriate place to permit its messaging to appear, that the sponsor must then submit that venue as part of the 2253 submission when it submits its own messaging. But how will FDA know that all of that additional content wasn’t created or approved by the sponsor?”Cooke also said that it would be deeply distressing if sponsors chose not to review an online communication channel just to avoid having to file the site under the 2253, which could lead to less responsible placement of materials. “I certainly don’t think that’s what FDA wants,” he commented. In addition, the FDA “appears to be holding online placement to a much higher standard for the 2253 filing than offline media in certain circumstances.”

He provided the following example to illustrate this point: “Let’s say I make a product in the men’s health area. I decide to run an ad in a special issue of Sports Illustrated dedicated to Major League Baseball’s All-Star game. Everybody would agree that I have to submit to FDA the print ad itself and never need to submit the issue of SI where the ad is running. But if I now sponsor the MLB.com coverage of the All-Star game, it appears that I have to submit all of the banner advertisements, etc., that will run in that section of MLB.com, along with all of the pages on which the ads are running.”

This scenario raises a number of questions and expands 2253 filing requirements to what could be an untenable situation, Cooke said:

  • What if MLB decides to add a page after I submit my 2253? Am I forbidden from continuing my ad buy on that page?
  • What about the fact that the content is news-driven and presumably not determined fully in advance?
  • How can I submit the pages on which I’m running my ads?

These issues will need to be clarified in the coming months, he noted. In a Jan. 13 Digitas Health Regulatory Alert, Cooke advised that companies take the following actions in light of the new draft guidance:

(1)    Review existing postmarketing submission filing procedures for compliance with the recommendations in the guidance, and update those as needed.

(2)    Review corporate social media policies and employee-generated content in owned social channels and update as needed.

(3)    Review agreements with key opinion leaders, bloggers, agencies and other agents of the company to ensure that postmarketing submission requirements are met.

(4)    Promulgate throughout the organization the expanded postmarketing filing requirements.

To view the full alert, click here.

For additional coverage, go to: Medical Marketing & Media at http://www.mmm-online.com/fda-eases-rules-on-ads-in-social-media/article/329225/?DCMP=EMC-MMM_Newsbrief&spMailingID=7756911&spUserID=NzAzNDA1MTY4ODQS1&spJobID=114455358&spReportId=MTE0NDU1MzU4S0

and Policy and Medicine at: http://www.policymed.com/2014/01/fda-guidance-for-industry-fulfilling-regulatory-requirements-for-postmarketing-submissions-of-interactive-promotional-media.html?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+policymed+%28Policy+and+Medicine%29