The July 9 deadline for the Food and Drug Administration to release guidance providing clarity for the use of social media for product promotion has come and gone. Fortunately, we have two fairly significant new pieces of the puzzle.
On June 17, the FDA issued guidance for industry on Internet and social media platforms with character space limitations and correcting independent third-party misinformation about prescription drugs and medical devices. Each draft provides clear examples of content "the FDA would not tend to object to."
As with all guidance, the goal is ultimately to ensure consumers have access to the most fairly balanced and accurate information about a product. So much of our clients’ fear of social media is based on a lack of understanding of the platforms and of FDA regulations. For us, there is a stronger need than ever before to help our clients use the guidance as a roadmap, rather than a barrier. If we educate them properly, we can reveal the immense opportunities to provide patients with the information and resources they need, and have requested from pharma, to inspire good health.
The first guidance provides recommendations for how to address the character constraints inherent in platforms such as Twitter and in sponsored links while fairly incorporating risks associated with a product. To be clear, this guidance is specific only to branded promotions on platforms with character constraints. It does not address other digital or offline channels, and does not speak to unbranded content. In summary, the guidance addresses three requirements for promotional copy on a character-limited platform:
Indication and benefits:
Must be "accurate and non-misleading and reveal material facts within…character-space limited communication." A material fact is information that would be necessary to a person making an educated decision. The guidance recommends referring to the label to develop the benefit language. It must also address specific limitations to the indication. The example provided is for a fictional drug, NoFocus. NoFocus is indicated for "mild to moderate memory loss." The omission of mild-to-moderate would not provide accurate benefit or indication information.
"Risk information should be comparable in content and prominence to benefit claims within the product promotion." Risks and benefits must be fairly balanced, and the most serious risk must be included. Additionally, all risks for a black box drug, all risks that could be fatal or life-threatening and all contraindications must be included. Once these risks are addressed, it is permissible to link to additional important safety information. The ISI page must be solely dedicated to sharing risks and cannot contain any benefits. A link from this landing page to a home page or other approved page is allowed. Finally, the link itself can be shortened, but it must be clear to the user that the link contains additional risk information. For example, the risk URL could look like this: www.nofocus.com/risk.
Other necessary information:
The generic name of the product should be listed directly to the right of, or directly below the brand name. Also, the landing page with additional risk information must contain both the brand and generic name as well as "at least one dosage form and quantitative ingredient information." Scientific abbreviations and punctuation marks may be used to conserve characters.
Detailed examples for each of these criteria are included in the guidance. There are no surprising requirements outlined in this guidance. Incorporating fair balance into a limited character count can be done for products without excessively complex risks, benefits, and indications. For those products, short-form promotions may not make sense. While some companies have been following an approach similar to that recommended in the guidance, others have not. The guidance on use of platforms with character constraints is fairly prescriptive and can help us discuss more branded opportunities, as appropriate in regard to overall communications objectives.
The second guidance focuses on the correction of misinformation posted by independent third parties. This guidance is actually quite liberating for the industry. By enabling industry to help correct inaccuracies about products in a factual, fair-balanced, non-promotional way, the FDA is empowering pharma to combat misinformation, which is defined as "positive or negative incorrect representations or implications about drugs and devices."
Such misinformation is truly a danger to patients. Nearly half of the guidance document specifies how independent, third-party content is defined. This is welcome clarification, following the guidance issued earlier this year, where the definition of "influence" was left rather ambiguous. Finally, the guidance does not require any follow up monitoring of the sites where correct information was posted or shared.
For content that is truly not influenced by the company, there is the opportunity – note, this is not required – to correct misinformation. To do so in accordance with the guidance, the company must:
- Be relevant and responsive to the misinformation (only address indications mentioned in original misinformation);
- Provide a limited and tailored response that is non-promotional in nature, tone, and presentation (note: must specify what is being corrected);
- Accurately present information that is consistent with FDA-required labeling;
- Include supporting evidence, when appropriate;
- Either post in the same area of a forum, blog, or comments section or reference the misinformation and post correction in conjunction with misinformation (can either post directly or contact site/channel administrator);
- Clearly disclose company affiliations;
- Provide access to labeling information via link to webpage or link to PDF (URL cannot be promotional in nature, i.e.: bestcancertreatment.com).
In short, correction of misinformation is not an opportunity to plug a product. It’s the chance to provide online information seekers with accurate product details so they can make an informed decision. For many of our pharma clients, we are already doing social listening. From that research, we have seen firsthand the vast amounts of inaccurate information about products that is being posted on discussion forums, Wikipedia, blogs, and through other online channels. As we share this guidance with our clients, we should explore opportunities for conducting audits of online patient resources to ensure accuracy.
The most recent guidance issued was written to protect patients by ensuring they have access to accurate, fair-balanced information about products. In today’s world, patient rely on digital channels for information, to ignore these platforms not only makes marketing programs a disservice, it prevents the latest information about treatments to be accessible from a reliable source.
People are talking about pharmaceutical products and medical devices online. Is your brand contributing to the conversation?
Jennifer Fuhrman-Kestler is digital director for healthcare at Golin.