Five years in the making, FDA’s new social media and “correcting independent third-party information” draft guidance was greeted as another gradual—but important—step in the right direction for marketers to deploy their digital and social tools without fear of a warning letter and being featured on OPDP’s wall of shame.
“Our initial reaction is one of optimism that the additional clarity on the communication of risk/benefit information on mediums such as Twitter will allow savvy marketers to start further innovating in those areas, with a guarded ‘green light’ from FDA,” Digital Healthcare Coalition managing director Christine Franklin told MM&M over e-mail.
“The continued challenge is to appropriately apply these hyper social opportunities to benefit both the industry, and more importantly, the patient,” she added.
While the industry has good reason to be optimistic, it did take FDA 15 pages to communicate its recommendations for a 140-character messaging service. In it, the agency says drug companies should rely on “material fact,” as in supported indications from a product’s ISI, and that any benefits should be juxtaposed with the drug’s limitations, contraindications or its relevant patient population—and the most serious side effects should be the most prominent. These rules do not include “reminder promotions,” however.
Just including safety information in a subsequent tweet won’t cut it either, unfortunately. The agency says each tweet must act as a kingdom unto itself, and remain balanced “within each individual space-limited communication.” That language seems to exclude any chance of including safety information in a string of tweets.
And just linking them to safety information isn’t sufficient, although the regulator recommends brands provide that as well. “In addition to presenting the most serious risk information, FDA recommends that firms include, in that communication, a direct hyperlink to a destination that is devoted exclusively to the communication of risk information about a product.”
To help marketers promote effectively in space constraints, regulators wrote that “URL shortening services [like bit.ly] are OK,” but that when space is available marketers should feature the entire the URL or web address and denote to the user that the landing page consists of risk information (e.g. www.product.com/risk), as well as that agencies should avoid promotional links, such as “www.bestcancercuredrug.com.”
Shortening of science abbreviations, punctuation marks and symbols used to save space are OK too, the agency wrote. “The Agency believes that common abbreviations, punctuation marks, and other symbols may…reasonably be used to help address character space constraints.”
And if it sounds like weaving your benefits and risks into 140 characters still isn’t a feasible task, the FDA has an answer to that problem, too: “If an accurate and balanced presentation of both risks and benefits of a specific product is not possible within the constraints of the platform, then the firm should reconsider using that platform for the intended promotional message.” In other words: try something else.
Working within that framework won’t be easy for marketers, Brad Einarsen, director of digital insight at the agency Klick Health, told MM&M. “Within Twitter, only a few brand marketers will benefit from the ability to post claims inside their tweets, but the FDA shows it can be done.”
In a second, and shorter, document, FDA issued its thoughts on how to handle misinformation by third parties, which the regulator defines as “information created or disseminated by independent third parties on the Internet or through social media or other technological venues,” and misinformation is any “positive or negative incorrect representation of a firm’s product.”
Off the bat, the agency says you can’t correct misinformation in a way that’s promotional; you have to only correct what a third-party got wrong. “Be non-promotional in nature, tone and presentation,” the regulator bulleted.
And you can’t cherry pick what you’d like to correct, either. The agency proposes that “if a firm chooses to correct only misinformation that portrays its product in a negative light in a third-party communication,” but fails to address misinformation about a drug’s benefit, then “the firm’s actions do not meet the recommendations in this draft guidance.”
The FDA also recommends that firms keep records of these exchanges, to assist with any possible inquiries.