Categories: FDA, Medical Device

Earlier this year, FDA released draft guidance the pharmaceutical and medical device industries had been awaiting for five years.  But instead of revolutionizing the Agency's thinking on drug and device promotion, FDA's social media guidance essentially continued the familiar credo on advertisements—accurate and not misleading, fair balance, substantiation—and ignored some of the central features of social media.  Last week, FDA reopened the comment period for the character-space limited communications and correcting third-party misinformation guidances.  Now companies have until October 29, 2014, to submit comments to FDA.

Our recently released article, "The Revolution Can Wait—Recent Social Media Marketing Guidance from FDA Gives Manufacturers More of the Same," in BNA's Medical Devices Law & Industry Report, explores the three draft guidance documents and identifies where FDA held its ground, where it gave a bit, and what questions remain for manufacturers.

The first shot in this year's social media salvo turned out to be fairly unremarkable as it set forth FDA's expectations for submitting interactive promotional media for review.  As expected, a company is responsible for, and must submit, the online information it creates or over which it has influence.  Although FDA indicated that it intends to interpret the scope of a company's influence broadly -- a company is responsible for content "even if the influence is limited in scope" – FDA did not provide much guidance for delineating the scope of a company's influence.  Therefore companies are left to wonder:

  • Does this include "liking" or "retweeting"?
  • Does it include the online activities of a lone employee?

The next two rounds came in rapid succession, drug and device promotions on character space limited platforms and correcting third-party misinformation.  The character space limitations guidance included examples of compliant social media communications via Twitter and Google sitelinks, which demonstrates that FDA is at least open to the idea of drug and device social media marketing as long as all of the traditional rules are followed.

  • However, what happens when the host site does not always display the entire promotion, such as when Google omits the sitelinks on sponsored advertisements?
  • If the sitelinks contain required risk information for a drug, will the manufacturer be blamed for the omission?

The draft guidance on correcting third-party misinformation elicited another collective shrug of industry's shoulders.  The new twist comes when companies voluntarily set out to correct information on third-party sites: fair balance is not necessary when making such corrections.  However, to take advantage of this exception, the correction must follow the remaining traditional rules and be narrowly tailored to the misinformation.  Choosing to correct multiple posts in a single forum makes the company responsible for correcting all misinformation in a "clearly defined" portion of the site.

  • But how does the company define the portion of the website it corrects?
  • How does FDA determine whether the company missed an opportunity to correct misinformation within that "clearly defined" portion?
  • Must the company correct all misinformation in the defined portion simultaneously?

The most significant question that remains after the current round of social media guidance is: how will FDA regulate social media endorsements (e.g., "liking" on Facebook)?  FDA did not address this central function of social media platforms which could significantly change the way manufacturers present drug and device advertisements and how consumers interact with them.  FDA is likely working on further guidance to explain how manufacturers may utilize these functions in promotions, but when the industry is likely to see such guidance is unclear.  If you want FDA to fill in this gap, as well as the other we identify in our article, go to and urge FDA to do so sooner rather than later.

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