January 5,2017

The Food and Drug Administration (FDA) usually reviews the results of studies conducted by the pharmaceutical industry, but industry leaders are in an unfamiliar position as they wait to hear the results of an FDA-sponsored study. The FDA recently announced its plan to study whether prompting readers to click on a link to access Important Safety Information (ISI) in communications with character limitations, such as banner ads and tweets, is an effective means of balancing promotional claims and ISI. Study results will presumably be used to provide definitive guidance on what has unofficially been called the “one-click rule.”

This study is the latest attempt to reconcile the highly regulated space of healthcare marketing with the fluid, rapidly evolving nature of social media. Although the FDA made a first pass at this in a 2014 draft guidance, it sidestepped the one-click rule altogether. While the guidance document may have been unclear, the FDA’s 14 warning letters cautioning against links being used in place of safety information were very clear—click won’t stick!

If there’s an antithesis for the word “clickbait,” it probably sounds something like, “Click here to read full prescribing and safety information.” When readers are presented with the full ISI, research shows that they tend to read very little, if any, of the cautionary material. Even when readers do elect to read the full ISI, they tend to recall only a small percentage of the information. Given low readership and retention rates, how should the FDA balance consumer protection with the pharmaceutical industry’s desire to fully engage in social media?

The debate over pharmaceutical promotion in the digital space centers around the FDA’s responsibility to help the public get the accurate, science-based information needed to maintain and improve their health. If the limited characters in a tweet or banner ad are used solely to promote a product, what’s the probability of a consumer ever accessing the full, unfiltered information they need to help determine if a medication is right for them? Perhaps the new guidance will allow for scaled clickability, such as a tiered system to weigh relative risk based on pregnancy class, boxed warnings, or indications for children.

I see this study as a microcosm of the larger push/pull relationship between the FDA and the pharmaceutical industry. The slow, deliberate nature of medical research doesn’t always pair well with the quickly evolving technological landscape, just as the FDA’s mission to protect public health can clash with its commitment to speed innovations in medicine. This study probably won’t answer all our questions about the one-click rule, but it will likely give us more information to consider when we debate the most effective, responsible ways to communicate health information in the digital space.


Jessie Toporek is a medical writer in Fingerpaint’s Scottsdale office. She’s worked for a nonprofit in Nepal, federal agencies in the United States, a small start-up in Australia, and multinational pharmaceutical and medical device companies. She is the reigning Ugly Sweater Contest winner for Fingerpaint’s 2016 holiday party, and doesn’t shy away from reminding coworkers that she believes this to be a significant personal and professional victory.

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