How to avoid “going viral” with the FDA

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Last month we shared the importance of performing auditing and monitoring as part of an effective compliance program. This month we’re focusing on social media.

A conforming social media program includes not only establishing a policy that addresses the latest FDA requirements for staff to follow, but also accounts for periodic auditing and on-going monitoring of company social media activity.

Are you curious about the health of your social media compliance? Contact us today to discuss how social media auditing and monitoring may benefit you.

A growing trend.

Sophisticated drug and device makers have finally jumped on the social media bandwagon. Leading manufacturers now have campaigns designed to educate consumers, promote products, engage health care professionals (HCPs), and raise awareness of new therapies.

Marketers love social media because it facilitates patient engagement via short, focused and attention-grabbing posts, health-related questionnaires, and the provision of “real-time” information. It’s also relatively inexpensive and easy to use. Paid advertising and search engine optimization (SEO) are often used in tandem with social media to drive awareness of new therapies. For example, targeted Facebook ads direct users to links where they can find out if they may be a candidate for a therapy and even find an HCP.

Social media questions to consider:

  • Do I have to share safety information in my product posts on Twitter?
  • Do I have to share safety information on Facebook, YouTube, LinkedIn, and Instagram?
  • Can I retweet live conference posts?
  • Can I share an article or event posted by an HCP customer?
  • What should I do when a 3rd-party posts information on my social media page that is off-label?
  • Can I “like” off-label” posts?
  • Can I encourage off-label conversations?
  • Do I have to report product complaints that I find on social media sites?
  • Can I force someone to take down a post?
  • Can I delete posts I don’t like?
  • Can anyone in the company post product information?
  • Can I share news about customers to help them generate more business?
  • Can I help promote my customer’s practice?

Common pitfalls.

Use of social media in the highly regulated drug and device industry is much more challenging than some may think. Despite the upside, social media use can put drug and device makers in legal jeopardy if FDA requirements are not followed. Avoiding a warning letter, or some other legal action, requires forethought and planning—which often comes as an unwelcome surprise to marketers.

Rules and issues to consider:

  • Social media does not offer a pass to the provision of safety information.
  • The “most significant” warnings or precautions must be communicated, among other things.
  • Responding to an off-label question or request on social media may be okay if FDA recommendations are followed but speculating about and promoting unapproved uses is NOT allowed.
  • Promoting unapproved/uncleared investigational products is barred per Parts 312.7 and 812.7.
  • Cherry-picking posts to “like” and/or delete presents risk.
  • Unsupervised forums may be an option, but they also present risks. Such platforms require careful planning.
  • Allowing staff to post can be acceptable but only under certain conditions outlined in written company policy and subject to copy review. Social media training is advised.
  • Drug (and biologics) manufacturers must follow special rules for submitting post-marketing social media communications to the FDA’s Office of Prescription Drug Promotion (OPDP).
  • Misinformation may be corrected as prescribed by FDA under certain circumstances.
  • Driving patients to particular customers raises serious kickback concerns as we recently shared in our September Regulatory Alert.
  • 3rd party users and manufacturers who post patient information may run afoul of HIPAA if patient permission is not gained before posting.
  • Consider how a plaintiff’s lawyer may use social media and internet campaigns against the company.
  • Consider what you would do if an unfriendly party bad mouthed the company on a social media platform.

FDA guidance.

FDA guidance documents and warning letters provide the basis of a “social media road map.” Best practice for creating a tailored road map for an organization entails considering what risks and obstacles are faced before the first post is ever made. Consider ascertaining: What is our risk profile? Do we have a written policy on social media use? What is allowed and what is prohibited? Who reviews posts before they are made? What special FDA rules apply to us?

FDA has issued four (4) guidance documents related to social media in an effort to provide clarity on various topics. These include:

FDA Warning Letters.

FDA warning letters also provide additional insight into current Agency thinking. FDA has issued many warning letters to companies for activities such as: liking or responding to a 3rd party comment in an inappropriate way, using metatags that misbrand a product, and failing to adequately disclose safety information.

For example, Kim Kardashian was famously warned by the FDA through her employer, Duchesnay, Inc., a drug maker, for a false or misleading post that presented efficacy claims for DICLEGIS®, an FDA-approved morning sickness medication, but failed to communicate any risk information associated with the use of the drug. The Agency also claimed that the post omitted material facts. Thus, FDA claimed that the social media post misbranded DICLEGIS® within the meaning of the Federal Food, Drug, and Cosmetic Act.

Social Media Program.

Are you interested in learning more? Join us at our October 29, 2019 CLE program entitled, “How to avoid ‘going viral’ with the FDA”. This CLE event focuses on the following topics:

  • Overview of FDA social media-related guidance documents
  • Social media and web-related enforcement examples (warning letters) and trends
  • Valuable insights and best practices on how to avoid common pitfalls when using social media, SEO and paid search

Need help with your social media, SEO and paid search campaigns? We can help you by:

  • Creating your social media and internet communication policy
  • Training staff
  • Performing an audit of company social media platforms
  • We specialize in reviewing the following platforms: Facebook, Twitter, LinkedIn, Instagram, YouTube, Google, Bing and Yahoo.

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