Now that Pharmarisc is back up and running, what better topic to discuss than the one that started this blog in the first place back in December, 2012 – the FDA’s incursion into manufacturers’ free speech rights. However, instead of focusing on Caronia, Par, et. al., lets take a look at the FDA’s June, 2014 Guidance re Internet/Social Media Platforms with Character Space Limitations – Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (“June Guidance”) and the free speech implications for manufacturers looking to use Twitter’s wildly popular platform to promote drug and medical device products.
The June Guidance came a few months after the FDA issued its January 2014, Guidance re Post-marketing Submissions of Interactive Promotional Media (“January Guidance”), which the agency stated includes promotion on blogs, microblogs, social networking sites, online communities and live podcasts. In Marbury v. Madison-esque fashion, the January Guidance declared at the outset that it is and always will be the province of the FDA to determine the reach and scope of its marketing regulatory regime and, to no one’s surprise, determined that its reach extended to the world of social media. Specifically, the January Guidance made clear that its rules on post-marketing submissions apply to 1) any site or social media platform in which the manufacturer exerts any influence, no matter how limited, including third-party sites; and 2) any content generated by a manufacturer and its agents, such as a paid speaker. The agency agreed that manufacturers would not be responsible for user generated content (UGC) even on a site it controls, such as chatboard, “as long as the user has no affiliation with the firm and the firm had no influence on the UGC.” The FDA then went on to tackle the issue of drug promotion on social media with interactive, real-time information, noting that the established post-marketing submissions process continued to apply to “static” sites (like a company-sponsored product website). The agency listed five “principles” to be applied in the submission of interactive promotional media that display real-time communications, including the different approaches that should be taken depending on whether access to the site is restricted. (See January, 2014 Guidance for a complete discussion of these principles).
The more interesting question of what the agency would say regarding Twitter and other microblog platforms with character space limitations, such as Google’s “Sitelink extensions,” was answered in the June Guidance. Using various hypothetical drugs, medical devices and scenarios, the June Guidance issued a series of so-called “non-binding recommendations” on how manufacturers can appropriately convey product benefit and risk information via Twitter, etc. Beginning with the premise that all promotion, regardless of platform, must be truthful, accurate, non-misleading and fair balanced, the agency announced the following basic rules:
- Any tweet or microblog posting that includes a product’s benefit, must also include its risks and other required information, or at least include its “most serious risks,” provided the manufacturer includes a hyperlink to a dedicated page or landing site that provides a comprehensive list of risks and side effects. Preferably, the hyperlink should be an unambiguous URL such as “product.com/risks.”
- Benefit information must be accurate and non-misleading with respect to both the approved indication(s) and any limitation regarding relevant patient population.
- Risk information must be communicated with the same degree of prominence as benefit information. If the platform’s formatting allows for differences, it would be permissible to highlight risk information over benefit information, but not the other way around.
- Other required information that must also be included within the tweet/post includes listing of both the product’s proprietary (trade or brand) name and established name (e.g., generic drug name). Any landing page associated with each hyperlink in the tweet/post must also include the product’s brand and established names and, if a drug product, must “prominently display at least one dosage form and quantitative ingredient information in direct conjunction with the brand and established names.”
- If the risk and other required information cannot be included with the benefit information in the same tweet/post due to character space limitations, then the manufacturer must refrain from posting all together . . . the “single tweet” rule.
The June Guidance did contain some good news that relieves manufacturers from “policing” and “correcting” the internet for inaccurate or misleading information about their products — provided the site is not controlled by the company — but if they do, they must limit the correction to the misinformation — and not use the opportunity to promote — and must do so in an accurate and fair balanced manner. What this means is that any information that a company corrects (e.g., exaggerated information about a product’s side effects) obliges the company to correct all misinformation (e.g., exaggerated information about a a product’s benefits), not just the misinformation that makes the product look bad. While the June Guidance doesn’t require manufacturers that correct misinformation to submit their corrections to the FDA, the agency recommends that companies document and maintain records of any such actions.
Observations on the Implications for Free Speech
In fairness to the FDA, the June Guidance never uses the word “must” (as I have done), but instead uses the word “should” to underscore that their “rules” were, strictly speaking, recommendations. That being said, the FDA knows quite well that, from a manufacturer’s perspective, there is no practical difference between “must” and “should” and that the Guidance (assuming it doesn’t change) should act as a safe harbor for those who follow it. Although most of the June Guidance rules don’t really pose unreasonable burdens on a manufacturer’s free speech rights — risks and other required information would have to be disclosed regardless of platform — some writers have quite correctly argued that the “single tweet” rule goes beyond the fair balance requirement and overly restricts manufacturers’ free speech rights, perhaps effectively eliminating Twitter and other microblog sites as an industry platform for communicating information about drug and medical device products, see here.
But there’s even more to limiting free speech in the June Guidance than just the single tweet rule. Tucked away beneath the hypothetical drugs, medical devices, scenarios and rules, lies a passage that underscores the agency’s determination to graft the “intended use” regulation at issue in Caronia and Par into the world of social media. As the second sentence of footnote 4 makes clear, “[r]epresentations by a firm in character-space-limited platforms may also provide evidence of the intended use of the product, but that issue is not the focus of this draft guidance” (emphasis added). In other words, if a drug manufacturer tweeted benefit and risk information about a particular product, but failed to accurately or adequately (in the FDA’s mind) convey appropriate indication or relevant population information in the tweet, the agency can and probably will use the tweet as evidence of the manufacturer’s “intent to promote off-label.” Thus, the single tweet rule and footnote 4 provide the kind of one-two punch that should knock most manufacturers and their drug and medical device products out of the Twitter ring, no matter how useful getting information from Twitter might be for the consuming public — and that can’t be a good thing.