Like It or Not? The FDA is Following Social Media

December 1, 2014

The FDA is watching to make sure pharmaceutical and drug device manufacturers aren’t “liking” social media posts that promote the off-label use of their drug, or posting about the benefits of a drug without any mention of the risks. In keeping up with the times, many drug and device companies have taken advantage of the information superhighway to expand their advertising and promotional reach. As tempting as it is, some companies have been hesitant to swim in the murky waters of social media promotion due to uncertainties about how the FDA would react.

In 2009, the FDA requested input from the public about appropriate promotional use via the Internet and social media in an attempt to catch up with technology since the FDA’s public meeting in 1996 to discuss issues related to promotion of FDA-regulated drugs and devices on the Internet.¹ The update was driven by new technologies and tools, such as blogs, microblogs (Twitter), podcasts, social media (Facebook), video sharing (YouTube) and wiki pages (Wikipedia).² In looking to redefine its social media guidance for industry, the FDA asked for input on the types of online communications manufacturers should be held accountable for, how industry would communicate both the benefits and risks, the parameters that should apply to posting of corrective information on websites controlled by third parties, when the use of links is appropriate and issues related to Internet adverse-event reporting.³

In June of 2014, the FDA issued two draft guidance documents on social media to help ensure accurate and truthful promotion and communication of drugs and devices by manufacturers. The first guidance provides recommendations for balancing both benefit and risk information when using social media platforms with character limitations, such as Twitter and paid search results on Google. The second guidance provides the FDA’s recommendations for companies to address the correction of misrepresentations or wrong information from third parties who post misinformation about their drug or medical device on the Internet. The director of FDA’s Office of Prescription Drug Promotion in the Agency’s Center for Drug Evaluation and Research (CDER) stated that the FDA is “committed to ensuring that the information about these products that their manufacturers and distributors direct at patients and healthcare providers is accurate and balanced.”⁴ Although these two guidances provide some clarity, it is clear that the FDA is still doing its due diligence to collect public comments. On September 26, 2014, the FDA posted that it is “reopening the comment period for the two draft social media guidances,” giving the public an additional 30 days to provide feedback.

CHARACTER SPACE LIMITATIONS – PRESENTING RISK AND BENEFIT INFORMATION FOR PRESCRIPTION DRUGS AND MEDICAL DEVICES:

Companies and the FDA have wrestled with how to address fair balance when faced with a constraint text or character space limitations. The two most widely discussed platforms include Twitter, which limits “tweets” to 140 character spaces, and online paid searches such as Google advertisements which are supposed to attach risk information through sitelinks.⁵ Critics of the FDA’s Social Media Guidance on Character Space Limitations have complained that companies could still be in violation of fair balance even if they follow the guidance because sitelinks containing risk information are not guaranteed to appear on Google Ads.⁶ Further complicating matters is that some descriptions of the sitelinks might not appear at all, and others might not appear on mobile sites due to character limitations, which could in essence cause the company to be advertising while not in compliance with fair balance if the FDA-required sitelinks fail to appear.⁷ Unfortunately, the FDA guidance failed to address various character and sitelink limitations imposed by the increasingly popular mobile platforms.⁸ While this guidance includes microblogs such as Twitter and online paid searches for Google-sponsored links, it does not provide guidance on product websites, webpages on social media platforms, online web banners or responsive web design (mobile device and tablet formats).⁹

An overview of the FDA’s policy is that companies should include risk information along with benefit claims regardless of character space constraints, while also providing a link to allow direct access of a more complete description of the risks associated with a drug or device. Companies should heed the FDA’s hardline approach: “If an accurate and balanced presentation of both risks and benefits of a specific product is not possible within the constraints of the platform, then the firm should reconsider using that platform for the intended promotional message.”¹⁰ Put simply, it might be best to stay away from promoting a drug or device via Twitter. The FDA used the example of a company considering the following post to Twitter, “NoFocus is indicated for mild to moderate memory loss. [40/140 characters],” suggesting that the company consider whether the remaining 100 characters are sufficient to convey the necessary risk and other required information.¹¹ Interestingly, the FDA has failed to comment on similar tweets, such as Pfizer’s 2012 tweet stating, “FDA Approves Lyrica® (pregabalin) capsules CV for Management of Neuropathic Pain Associated w/Spinal Cord Injury on.pfizer.com/M80A5M.”¹²

What is confusing is that the FDA does not necessarily follow the same guidance that it is requiring the industry to follow. In the above example from the FDA’s guidance, the FDA clearly questioned the sufficiency of a tweet that only included the name of the drug and the indication; however, in an October 10, 2014, post, the FDA tweeted, “FDA approves Akynzeo (nteupitant and palonosetron): go.usa.gov/wyX5.”¹³ It is unclear whether the manufacturer of Akynzeo could post this same tweet without any repercussions. At a minimum, companies should include a link to a site that contains the full discussion of the risks associated with the drug or device at issue.

CORRECTING INDEPENDENT THIRD-PARTY MISINFORMATION ABOUT PRESCRIPTION DRUGS AND MEDICAL DEVICES:

Fortunately, drug and device companies are not responsible for policing the Internet universe in order to correct any misinformation about their products when the user-generated content is truly independent of the company.¹⁴ Companies are, however, on the hook for statements made on the Internet or through social media by “its employees or any agents acting on behalf of the firm to promote the firm’s product.”¹⁵

The FDA’s 2014 guidance clearly requires fair balance and that the company correct misinformation when statements on a website include some form of “control over, involvement with or influence over a product-related communication” by the company.¹⁶ In other words, companies are responsible for content on third-party sites if the company has any control or influence over the site, collaborates or has editorial privileges, or influences the placement of its promotion within the third-party site.¹⁷ For instance, a company is not obligated to correct misinformation if a blogger posts “misinformation” about a drug if the company did not host the website, have review privileges, place an advertisement on the blog’s website or have a relationship with the blogger. Keeping in line with the FDA’s guidance, if a company decides to correct a third party’s Internet post containing misinformation, then the company should clearly identify the misinformation that it is correcting, provide a statement that it is responding only to the specified information, and provide a direct link to the FDA-required labeling. While companies have an incentive to correct misinformation about overexaggerated risks of their drugs or devices, they should also correct misinformation about exaggerated benefits.¹⁸^,¹⁹Companies are expected to keep records of instances where they correct misinformation from nonrestricted sites, but they are not expected to report corrections to the FDA.²⁰ The FDA also recommends that companies submit an updated listing on a monthly basis of all nonrestricted sites for which the company is responsible or remains an active participant.²¹

Drug and device companies should implement policies setting out strict guidelines for sales reps posting comments on social media and videos to YouTube. An example that the industry can learn from is a May 5, 2011, untitled letter the FDA issued to a drug company because of a “misleading” video about a drug that one of its sales representatives posted on YouTube.²² The FDA found that the video was misleading because “it makes representations about the use of Atelvia, but fails to present any risks associated with the use of Atelvia and fails to disclose the drug’s indication. The video also presents dosing claims for Atelvia that omit material facts and that are misleading.”²³ The dosing statement was considered misleading because it stated “can eat and drink with in the morning” instead of the labeling which states, “should be taken in the morning.”

There is nothing to “like” about receiving a Warning Letter from the FDA. The FDA issued a February 26, 2014, Warning Letter to a drug company for “liking” a customer’s post on the company’s Facebook wall that promoted off-label use of the drug.²⁴ On March 10, 2011, the company “liked” a post that stated, “PolyMVA 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…”²⁵ The problem is that the company marketed the drug as a dietary supplement without ever seeking FDA approval as a drug designed to treat any specific disease.²⁶

HOW MANUFACTURERS CAN HANDLE THE CHALLENGES OF SOCIAL MEDIA:

Pfizer and other drug companies have utilized editorial features giving them the ability to delete Facebook users’ inappropriate or misleading comments that could subject the company to an unwelcomed FDA warning letter. The “Comment Missing?” section on Pfizer’s Facebook page provides a detailed list of reasons why Pfizer would delete a user’s comment. For example, Pfizer might have to delete a user’s comment from its Facebook wall if it lacks fair balance when discussing a product or describes a side effect that the user has experienced. In both instances, Pfizer has linked users to the FDA website for a definition of fair balance as well as the FDA’s MedWatch adverse-event reporting page.²⁷

FDA’s Definition of Fair Balance:²⁸

The law requires that product claim ads give a “fair balance” of information about drug risks as compared with information about drug benefits. In other words, the content and presentation of a drug’s most important risks must be reasonably similar to the content and presentation of its benefits. This does not mean that equal space must be given to risks and benefits in print ads, or equal time to risks and benefits in broadcast ads. The amount of time or space needed to present risk information will depend on the drug’s risks and the way that both the benefits and risks are presented. In the wake of the FDA’s interest in monitoring social media, companies should: (1) keep a close watch over sales rep videos on YouTube, (2) constantly monitor the company’s Facebook activity, (3) vigilantly correct any misinformation contained on third-party sites where the company has control or influence over the content, and (4) avoid “liking” unapproved claims contained in Facebook posts that lack fair balance or promote off-label use. Also, when hosting forums over social media, companies should monitor third-party comments, and include a clear, conspicuous statement that the company did not create t

[i] Federal Register, 74 FR 48083 – September 21, 2009. http://www.gpo.gov/fdsys/pkg/FR-2009-09-21/pdf/E9-22618.pdf

[ii] Id.

[iii] Id.

[iv] FDA Issues Draft Guidances for Industry on Social Media and Internet Communications About Medical Products: Designed with Patients in Mind. Posted on June 17, 2014. http://blogs.fda.gov/fdavoice/index.php/2014/06/fda-issues-draft-guidances-for-industry-on-social-media-and-internetcommunications-about-medical-products-designed-with-patients-in-mind/

[v] Guidance for Industry. Internet/Social Media Platforms with Character Space Limitations – Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices. June 2014.

[vi] FDA Was Wrong About Google Functionality. http://regulatoryrx.blogspot.com/2014/06/fda-was-wrong-about-google-functionality.html

[vii] Id.

[viii] Guidance for Industry. Internet/Social Media Platforms with Character Space Limitations – Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices. June 2014.

[ix] Drug Industry Rips Into FDA Over Social Media Guidelines: A Summary of Industry Comments Regarding Twitter & Google Adwords. http://www.virsci.com/pmn/PMN1308-03charlimit.pdf

[x] Guidance for Industry. Internet/Social Media Platforms with Character Space Limitations – Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices. June 2014.

[xi] Id.

[xii] Drug Industry Rips Into FDA Over Social Media Guidelines: A Summary of Industry Comments Regarding Twitter & Google Adwords. http://www.virsci.com/pmn/PMN1308-03charlimit.pdf

[xiii] https://twitter.com/FDA_Drug_Info

[xiv] Guidance for Industry. Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices. Draft Guidance. June 2014.

[xv] Id.

[xvi] FDA Issues Draft Guidances for Industry on Social Media and Internet Communications About Medical Products: Designed with Patients in Mind. Posted on June 17, 2014. http://blogs.fda.gov/fdavoice/index.php/2014/06/fda-issues-draft-guidances-for-industry-on-social-media-and-internetcommunications-about-medical-products-designed-with-patients-in-mind/

[xvii] FDA Social Media Draft Guidance Webinar. July 10, 2014. http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM404562.pdf

[xviii] Id.

[xix] Id.

[xx] Id.

[xxi] FDA Social Media Draft Guidance Webinar. July 10, 2014. http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM404562.pdf

[xxii] FDA Untitled Letter to Warner Chilcott. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM254562.pdf

[xxiii] Id.

[xxiv] FDA Warning Letter: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm340266.htm

[xxv] Id.

[xxvi] FDA Targets Companies for Facebook ‘Likes.’ Is Twitter Next? http://www.raps.org/Regulatory-Focus/News/2014/08/12/20014/FDA-Targets-Companiesfor-Facebook-Likes-Is-Twitter-Next/