Dive Brief:
- The Food and Drug administration wants to know whether a simple link to risks is effective when a prescription drug's benefits are promoted online within the character and space constraints of social media sites.
- The FDA thinks the answer may be "no." To test its theory, the agency intends to conduct four studies, testing how well participants retain risk information for fictional drugs for weight loss and migraine that is presented in different formats (two using Google-sponsored links and two using Twitter and its 140-character limit per tweet). FDA posted notice of its research plans November 7; public comments are due by January 6, 2017.
- In 2014, the FDA released draft guidance calling for a prescription drug's benefit and risk information both to appear within the same character-space-limited communication. The regulator stated companies also should provide a mechanism allowing direct access to more comprehensive information on product risks.
Dive Insight:
FDA's prescription drug regulations require pharma to offer a fair balance of the content and prominence of risk and benefit information in product claim promotions.
But the increasing popularity of internet communications with character and space limitations, including sponsored link promotion and microblog messaging, has thrown regulators for a loop. They wonder how such online communications can be used for drug promotion while complying with balance requirements.
The FDA is speculating that study participants who view substantive drug-risk information contained in the character-space-limited communication itself will have greater retention than link-only participants. FDA also thinks people searching for specific information, not just browsing, will better grasp a drug's risks.
What's clear is that pharma is starting to embrace social media platforms, with dozens of companies using multiple Twitter accounts to connect with patients. Yet given the FDA's regulations calling for a balance of benefit-risk information, many firms are shying away from actual product promotion.
Jeffrey Ross, Washington, D.C.-based president and CEO of Wunderman Health, a healthcare marketing firm that works with the top 10 global pharmaceutical companies, sees the FDA's work as "a positive development." He said in an interview it will "give industry more guidance on how pharma can embrace social media more and leverage it in their communications...and come up with creative solutions that allow [companies] to use platforms" like Twitter and other space-limited social media sites.
Over the years, the FDA has looked at how drug companies must approach television and print marketing, but the agency hasn't focused on digital media, which is "a big frontier" for pharma, Ross said. He recalls that in 1997 the FDA changed pharmaceutical marketing guidelines related to using abbreviated drug-risk statements with links to other types of information (not just online). "That opened doors," he said, adding the FDA now seems to be recognizing that social media hasn't been leveraged in the way it can be to deliver healthcare information to consumers.