In the five years since the open public meeting on social media, the FDA has occasionally shared their thinking via letters and draft guidance. They provided more clarity on June 17, 2014 by simultaneously issuing draft guidance on two separate topics: “Internet/Social Media Platforms with Character Space Limitations — Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices” and “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices.”
It’s important to note that both refer specifically to prescription drugs (human and animal) and medical devices. Let’s start with the first document, which I’m nicknaming “The Twitter/Paid Search Guidance.”
TWITTER/PAID SEARCH GUIDANCE SUMMARY
The draft guidance recommends how to include risk/benefit information on sp ecific channels with character limits (e.g. Twitter and paid search).
No matter what the space limitations, companies must post both the benefits and main risks associated with a product within the same message or tweet, with a hyperlink taking the reader directly to a more detailed list of risks (and not simply the homepage of the promotional site). They provide specific examples that include the use of URL shorteners, as well as common and scientific abbreviations. For paid search media advertising (e.g. Google and Yahoo!), this guidance outlines how companies can make use of multiple links within each ad to satisfy fair balance requirements.
- Clear direction on how branded promotional tweets and paid search advertisements are possible.
- Stresses that for products with complex indications or serious risks, it may not be appropriate to use digital platforms that have character limitations as a communications vehicle.
- Other social media platforms with longer form textual opportunities are not in scope of this guidance; until further clarification, standard FDA promotional guidelines would still apply.
This FDA draft guidance offers new possibilities for brands.
1) Evaluate paid search advertising campaigns: Review any current brand promotional ads utilizing vanity URLs that redirect to the brand site. Consider creating new branded, promotional ads based on this guidance. We recommend performing tests to compare which type of paid search brand ads are more effective. This draft guidance provides new options for promotional Paid Search ads that may prove valuable for brands—although it will need thorough testing to determine success.
2) Consider if Twitter is right for the brand: In some cases, branded promotional Twitter accounts may support the brand goals. However, after the benefit/risk information and link to risk is included in a tweet there will be very few remaining characters left for additional messages or links. These instructions will likely make it very difficult for a brand to implement in practice. Reminder ads can still be used. In addition, the severity and complexity of the product or device (and the length of the brand/established names) may preclude the channel. Moving forward, it will be interesting to see how many brands are willing and able to utilize Twitter as a promotional vehicle.
CORRECTING MISINFORMATION GUIDANCE SUMMARY
The draft guidance recommends how companies may choose to correct misinformation (both positive and negative) related to their own product.
The FDA focus on “misinformation” defined as: Positive or negative incorrect representations or implications about a firm’s product created or disseminated by independent third parties who are not under the firm’s control or influence and that is not produced by, or on behalf of, or prompted by the firm in any particular.
Firms may choose to correct misinformation. This still holds true if the misinformation occurs in the context of User Generated Content (UGC), regardless of whether the firm owns or operates the platform (or not) on which the communication appears.
The corrective information does not need the full balancing of risks and benefits that are normally required, as long as the following criteria are met: be relevant/responsive, limited and tailored to misinformation, non-promotional in nature/tone, accurate, consistent with FDA label, be supported by data, post in the same area as the misinformation and provide full disclosure that the poster is affiliated with the company. A subtle (but important) recommendation is that a firm may choose to provide contact information, giving the example of the company’s Medical Affairs Department. A strong suggestion that the corrective information has FDA-required labeling included or provided in a readily accessible format (e.g. PDF).
Companies do not have to correct each piece of misinformation in an entire forum, but should clearly identify what misinformation is being corrected, with as much specificity as possible. However, do not cherry pick and leave other more “positive” misinformation.
Also, in the unlikely case that a reportable Adverse Event is seen, follow the normal process.
Outside of scope:
- Once the company corrects misinformation, company is not expected to continue to monitor.
- If a company asks an author to correct misinformation, the company is not responsible if this does not occur.
- A company does not need to submit corrective info to FDA, but should keep detailed records of all corrections and interactions.
- Companies can correct fully independent third-party online misinformation without specifically exerting the full scope of fair balance.
- Given limited resources of companies and the disparate levels of impact of different online platforms, it will be important to prioritize the platforms/forums before addressing misinformation (e.g. prioritize according to reach and relevance)
1) Analyze the popular online third-party information on your brand: If you don’t know already, determine where there is misinformation and how egregious it is. Then rate the sites for reach and relevance to your target audiences. This will help you analyze whether it is worth correcting misinformation and, if so, prioritize the sites. For example, if Wikipedia has misinformation on your product page, this would be worth the effort to correct as Wikipedia is an extremely popular destination for both HCPs and patients. We can provide the analytics data and work with clients to ethically and appropriately share information with Wikipedia.
2) Ensure clear internal guidelines around how to correct misinformation: Review current employee guidelines to ensure that they specifically address the issue. Make sure these include very clear instructions for employees about what to do if they come across misinformation (e.g. forward to Communications team); ensure there is clarity about who is allowed to make changes (e.g. Medical Affairs team) and how they must do it (e.g. full disclosure and requires approval). Roll out revised guidelines (and relevant training) in targeted manner to make sure all affected stakeholders (including partners/agencies) are aware and aligned.
3) Education and training: In light of the guidance and the ever evolving landscape of digital communications, it will be critical to educate employees (and external partners, agencies, etc.) and ensure that they understand these documents and know explicitly how to proceed should they find misinformation.
Talk to your medical, legal and regulatory teams: Have a discussion around these new guidelines to learn their point of view. This is the POV that counts the most. We are available to help clients with this discussion.
Listening and analytics: It remains extremely important to have a finger on the pulse of the ongoing conversation around healthcare and social media. Monitoring brands online and the dialogue around them will help shed light on what is currently being discussed and how people are engaging—or hope to engage—with brands.
We understand that many questions still remain as the FDA will continue to evolve their recommendations, and we look forward to working with our clients to explore these new opportunities.
While my name is on this blog post as author, the thinking behind it came from a team of people including Colin Foster, Erin Bittner and Carissa O’Brien. One final note: I do commend the FDA for releasing this 3 weeks before the July 9 deadline – I was expecting it on July 3rd!