As many of our life sciences clients know, 2014 brought long-awaited draft guidance documents from the FDA regarding three social media-related topics of interest. The FDA provided its much-anticipated views on:
- The timing and procedures for pharmaceutical and biologics companies to submit interactive promotional media to the Agency (See Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics (the “Postmarketing Submissions Guidance”));
- The conditions under which pharmaceutical and medical device companies can voluntarily correct independent third-party misinformation on the internet and social media platforms (See Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices (the “Correcting Misinformation Guidance”)); and
- The requirements relating to presentation of risk/benefit information for pharmaceutical and medical device products on internet or social media platforms with character space limitations (See Internet/Social Media Platforms with Character Space Limitations – Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (the “Character Limitations Guidance”)).
As we near year end, the comment period for each of these draft guidances has come to a close. The dozens of comments submitted to the FDA address a broad range of policy, legal and technical issues – some making discreet, nuanced suggestions or requests for clarification, and others posing broader critiques of FDA regulation in the social media age. We have identified a handful of these broader issues that the FDA will need to grapple with and ultimately address as it moves toward finalizing the guidance documents.
Criticism of the FDA’s “Influence” Test as Overly Broad and Exceeding FDA Authority
In both the Postmarketing Submissions Guidance and the Correcting Misinformation Guidance, the FDA indicated that a firm is accountable for a communication if the firm merely “influenced” the communication. In the Postmarketing Submissions Guidance, the FDA stated that firms are responsible for product promotional communications on a site—and therefore required to submit those communications to the FDA—if the firm “exerts influence over a site in any particular, even if the influence is limited in scope” or on a third-party site “if the firm has any control or influence on the third-party site, even if that influence is limited in scope.” (Postmarketing Submissions Guidance at 3, 4 (emphasis added)) Similarly, in the Correcting Misinformation Guidance, the FDA stated that a firm is responsible for “communications that are owned, controlled, created or influenced . . . by, or on behalf of, the firm” and is therefore required to comply with regulatory advertising and labeling requirements when correcting misinformation (e.g., submission of a Form 2253, fair and balanced presentation of benefits and risks). (Correcting Misinformation Guidance at 3 (emphasis added))
Numerous comments urged the FDA to remove the “influence” test from these two guidance documents, arguing that it is overly broad and exceeds the FDA’s authority. If a firm’s “influence” on a communication or a website or other social media platform triggers regulatory requirements, a firm could conceivably be accountable for any statement about its product. “Influence,” many comments pointed out, is a sufficiently vague term that a manufacturer cannot possibly discern whether and when it has “influenced” a particular communication about its products. Commenters further pointed out that no statutory or regulatory authority supports the FDA’s assertions that it may hold a firm accountable for statements not made by or on behalf of the firm. Commenters generally agreed that a firm should only be held accountable for statements made by or on behalf of the firm, i.e., those that it causes or controls.
Criticism That the FDA’s Social Media Guidelines Effectively Prohibit Use of Character-Limited Social Media and, Thereby, Raise First Amendment Concerns
Several commenters expressed concerns that the Character Limitations Guidance—due to the scope of the risk disclosures it requires—effectively prohibits the use of character-limited social media platforms for many products, and therefore violates the First Amendment. These commenters pointed to the FDA’s statements that “[r]isk information should be presented together with benefit information” within each individual message or Tweet, that “[a]t a minimum, a firm should communicate the most serious risks associated with the product together with the benefit information,” that for prescription drugs the firm should communicate “all risk concepts from a boxed warning, all risks that are known to be fatal or life-threatening, and all contraindications from the approved product labeling,” and that for devices, “if a particular risk is associated with a particular identifiable use or population, then each of those should be included” within the message or Tweet. (Character Limitations Guidance at 9) The FDA stated that a firm “should reconsider” using a social media platform if it is not able to communicate “adequate benefit and risk information, as well as other required information” within the character limitations of the platform. (Id. at 7)
Some commenters argued that these restrictions constituted nothing less than presumptively unconstitutional content-based restrictions on speech. Other commenters argued that the speech the FDA seeks to regulate through the guidance documents is not all “commercial speech” (i.e., speech that “does no more than propose a commercial transaction”) subject to a lower level of First Amendment scrutiny, and any restrictions on it must therefore meet the rigorous requirements applicable to noncommercial speech. Finally, commenters pointed out that the FDA has limited authority to regulate product labeling and certain advertisements, and even that authority has been questioned in recent court decisions holding that truthful, non-misleading speech about a regulated product is protected by the First Amendment.
Criticism That the FDA’s Regulations Misconstrue the Purpose of Social Media
A number of commenters expressed the view that the requirement that every character-limited Tweet or message should include balanced risk and benefit information misconstrues the purpose of social media advertising. The commenters were concerned that the Character Limitations Guidance requires firms to provide the same type and quantity of risk/benefit information in a character-limited social media communication that they provide in a traditional advertisement. Unlike traditional media, however, they noted that character-limited social media is routinely – and appropriately – used to engage consumers and direct them to more complete presentations of product information. For instance, Tweets or other messages are often designed only to direct a consumer to a product website in which full risk/benefit information can be provided. The commenters observed that consumers interacting with social media platforms anticipate the need to click hyperlinks or otherwise interact with the social media communication to obtain additional information about a product. The commenters were critical of the FDA’s attempt to regulate Tweets and messages as stand-alone product advertisements rather than recognizing that the audience of such character-limited communications often, appropriately, views them as the entry point to more detailed information. In short, they observed, consumers of social media recognize that the communications they receive are limited and anticipate having to interact with the communications—by clicking hyperlinks or otherwise—to obtain complete information on the relevant products.
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Overall, commenters expressed appreciation for the guidance provided by the Agency while noting areas of continued concern and uncertainty. Nevertheless, the commenters made clear that they hope the Agency's final guidance documents will provide additional, clearer guidance on the issues they raised. Until the Agency finalizes the guidance documents, industry can continue to look to the FDA’s enforcement efforts for insights into its views on appropriate social media communications. As the nature and scope of social media communications and the accompanying technology continue to advance, it will be vital for the Agency to stay abreast of technological changes and provide industry with sufficient flexibility to effectively and accurately communicate with consumers.