Late last year, the Food and Drug Administration (FDA) for the first time issued a warning letter based on a company’s “like” of a Facebook user’s public post. Although this is the first time the Agency has addressed that particular issue, it is not the Agency’s first foray into the world of social media. Indeed, the FDA has shown a consistent awareness of manufacturers’ social media spaces. Companies must therefore be vigilant about their social media activities, always cognizant that the traditional regulations apply to these new online spaces.

FDA Guidance on Off-Label Use and Social Media

For a number of years, FDA has shown interest in whether and how social media can be used to promote FDA-regulated products. In 2009, the FDA held a meeting broadly titled “Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools.”¹ The FDA’s stated purpose in holding the hearing was “to provide an opportunity for broad public participation and comment on promotion of FDA-regulated medical products (including prescription drugs for humans and animals, prescription biologics, and medical devices) using the internet and social media tools.”² The hearing lasted two days and included presentations from a broad spectrum of interested parties, including major pharmaceutical companies, marketing and public relations companies, and websites.

Despite the far-ranging goals of the hearing, the official publication of the FDA subsequent to the meeting was less broad in scope. In December 2011, the FDA issued the Draft Guidance Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices.³ The Guidance provides an overview of the FDA’s regulations regarding responses to unsolicited and solicited requests for information about off-label use and provides guidance to companies in distinguishing between unsolicited versus solicited requests in the realm of social media.

The Guidance is relevant to a company’s use and maintenance of a Facebook page. Because communications about off-label use through a company’s public Facebook page would typically be viewable by all Facebook users, such communication would be considered “public unsolicited requests for off-label information” under the Guidance. This would be distinguished from a “solicited” request, which would be prompted in some way by the company’s own Facebook posting. For public unsolicited requests, the FDA offered four basic guidelines:

1. The company should only respond to requests pertaining specifically to its own named product.
2. The public response should not include any off-label information. Rather, the public response should convey that an unapproved or uncleared use is at issue and provide contact information for medical/scientific personnel for the user to follow up with that personnel independently.
3. Responding representatives should clearly disclose their involvement with the manufacturer.
4. Public responses should not be promotional either in nature or in tone.

Plainly, the FDA’s position is that a company’s permitted public response to a request for off-label information is very limited: No off-label information should be conveyed, and the public online conversation should immediately become non-public and offline.

Past FDA Enforcement Action Regarding Facebook Activity

The year after its hearing on social media, the FDA issued its first enforcement letter specifically directed at Facebook activity. In July of 2010, the FDA’s Division of Drug Marketing, Advertising, and Communication (DDMAC) issued a letter to drug maker Novartis stating it misbranded the drug Tasigna through its use of the “Facebook Share” widget on its website for Tasigna.⁴ The “Facebook Share” button on the Tasigna website had allowed the consumer, with two clicks, to post a link to the Tasigna page on his or her own personal Facebook page, which also included a thumbnail image and brief description. Users could add additional content when they shared the page, but could not edit the original text, URL, or graphics created by Novartis. The content in its entirety consisted of a title, link, and a few lines of text briefly describing the drug.

Why did the FDA get so worked up about posting a few lines and a seemingly harmless link? Though acknowledging that the hyperlinks took users to Tasigna websites, which did contain the pertinent risk information, the FDA nevertheless found this content misbranding under the Federal Food, Drug, and Cosmetic Act (FDCA). The FDA concluded that the shared content was misleading because it made representations about the efficacy of Tasigna without communi­cating any of the risks associated with the drug’s use. Moreover, the Agency concluded that the shared content inadequately communicated the indications of Tasigna and implied superiority over other products. In addition, the FDA cited the company for failing to submit the labeling for FDA approval. Though the company had previously submitted its website content to the FDA pursuant to the pertinent regulations, the FDA found the “shared content” not submitted as required.

Though this was the first time the FDA had issued such a letter related to Facebook, the FDA’s approach in the Novartis scenario was consistent with the FDA’s prior position on similar online advertising. On April 2, 2009, the FDA issued a whopping fourteen Warning Letters to pharmaceutical companies regarding their use of sponsored links on Google advertising searches.⁵ The advertisements in question appeared on Google users’ search results pages as sponsored links, with a few lines of text and a link to the drug companies’ websites. The FDA found that the advertisements misbranded the drugs in violation of the FDCA. The FDA found such ads misleading because, with the few lines of text, they did not include the products’ risk information, did not adequately communicate the products’ indication, and did not use the full, established name for the drugs. Thus in both the Novartis scenario and with the Google advertisements, a few lines of text and a link was not permissible advertisement because, inter alia, of failure to include risk and other required information.

Since its letter to Novartis, the DDMAC has issued a number of Warning Letters about various Facebook activities by companies. These actions have all concerned content generated by the company itself: information in the “Info/About” section,⁶ links posted by the company on its Facebook page,⁷ a video posted by a company on its Facebook page,⁸ “wall posts” by the company,⁹ as well as the company’s comments posted in response to a customer’s wall post.¹⁰

Well, okay, then. What about a Facebook “like”? Won’t the FDA let me do that? In a word, no. At least, not if the “like” involves an unapproved use.

The “like” button on Facebook consists of a “thumbs-up” sign next to a posting or photograph. According to Facebook, clicking the “like” button on a post “is an easy way to let someone know that you enjoy it, without leaving a comment.”¹¹ In late 2012, the FDA for the first time issued a Warning Letter about a company’s adoption of a customer’s statement via the Facebook “like” function.¹² The Warning Letter was sent to AMARC Enterprises Inc. on December 11, 2012, but was not published on the FDA website until March of 2013.

AMARC Enterprises Inc. is a seller of dietary supplements for humans and animals under the brand name Poly-MVA. Among other observations of violations made by the company concerning the Poly-MVA website information packet, the FDA’s Warning Letter noted the company acted improperly by “liking” on its Facebook page the following post by a purported user of the product:

Poly-MVA has done wonders for me. I take it intravenously 2x a week and it has helped me tremendously. It enabled me to keep cancer at bay without the use of chemo and radia­tion…Thank you AMARC.

According to the FDA, the company’s “liking” of this post constituted a “claim” by the company that the product could perform as stated.

Based on this latest action, it is apparent that in the context of social media, the FDA gives broad interpretation to what constitutes a company claim. Though at present this interpretation has only been applied to a “liking” of a post, it is conceivable that the FDA could apply this reasoning to a company’s acquiescence to users’ Facebook postings on the company’s wall. Because a company has the ability to delete offending comments from its own wall, the FDA very well may require companies to remove any off-label or otherwise impermissible comments, with the idea that acquiescence constitutes an improper “claim.”

In Conclusion

While companies await further official guidance from the FDA regarding permissible uses of their social media spaces, a few themes have crystallized from the FDA’s enforcement actions. Specifically, 1) The FDA reviews statements on social media spaces labeling, and any statements will be governed by traditional labeling rules, and 2) a company will be held responsible not only for its own generated content on Facebook, but also for any apparent endorsements of posts by others. These two principles greatly circumscribe a manufacturer’s ability to fully utilize social media in relation to its products. Indeed, a review of the major pharmaceutical manufacturers’ social media sites shows little if any product-specific information at all. Until the FDA issues further guidance or shows a change in position, manufacturers must carefully limit their Facebook activities, with the hope that in the future the FDA will change course to allow

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[i] FDA, “Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools,” Meeting Page, Nov. 12–13, 2009. Available at <http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm184250.htm>. Last accessed March 31, 2013.

[ii] Id.

[iii] FDA, Draft Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices, Dec. 2011. Available at <http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM285145.pdf>. Last accessed March 31, 2013. The Guidance has not yet been made final.

[iv] FDA, “Letter to Novartis Pharms. Corp.,” July 29, 2010. Available at <http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/
WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM221325.pdf>. Last accessed March 31, 2013.

[v] Letters summaries available at <http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/Warning
LettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM055773>. Last accessed March 31, 2013.

[vi] FDA, “Warning Letter to AloeElite,” Mar. 30, 2011. Available at <http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm253987.htm>. Last accessed March 31, 2013. FDA, “Warning Letter to Cellular Rx,” May 25, 2011. Available at <http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm256922.htm>. Last accessed March 31, 2013.

[vii] FDA, “Warning Letter to From Fatigued to Fantastic, LLC,” Apr. 18, 2012. Available at <http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm301795.htm>. (Regarding link to company’s website, where com­pany’s website included improper claims); FDA, “Warn­ing Letter to Vitality Distributing, Inc.,” Apr. 24, 2012. Available at <http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm301669.htm>. Last accessed March 31, 2013. (Regarding links posted of third-party articles.)

[viii] FDA, “Warning Letter to Quincy Bioscience Manu­facturing,” Oct. 16, 2012. Available at <http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm324557.htm>. Last accessed March 31, 2013.

[ix] FDA, “Warning Letter to Nature’s Rite,” Sept. 19, 2011. Available at <http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm273464.htm>. Last accessed March 31, 2013; FDA, “Warning Letter to For Earth, Inc.,” Aug. 19, 2011. Available at <http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm271386.htm>. Last accessed March 31, 2013. (Regarding com­pany’s wall posts); FDA, “Warning Letter to Cellular Rx,” May 25, 2011. Available at <http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm256922.htm>. Last accessed March 31, 2013. (Regarding compa­ny’s wall posts and posting of customer testimonials.)

[x] FDA, “Warning Letter to Cellular Rx,” May 25, 2011. Available at <http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm256922.htm>. Last accessed March 31, 2013.

[xi] Facebook Help Center, “What Does It Mean to ‘Like’ Something?” Available at <https://www.facebook.com/help/452446998120360>. Last accessed March 31, 2013.

[xii] FDA, “Warning Letter to AMARC Enterprises,” Dec. 11, 2012. Available at <http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm340266.htm>. Last accessed March 31, 2013.

Finis