From our sister blog, MoFo Tech:
Two FDA Guidelines Help Life Sciences Companies Solve Social Media Conundrums
Social media presents new challenges for life sciences companies. Companies that post about their products on space-constrained social media platforms such as Twitter or Facebook don’t have the luxury of a full page or a long voiceover listing risks or side effects. And it’s unclear how to respond to misleading information about products posted online by third parties. In June, the Food and Drug Administration produced two much-anticipated draft documents that provide some guidance in each case.
The “Twitter Guidance”
“Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices” (found at http://1.usa.gov/1kGYdgK) specifies that a brand should, within the post:
- Include the brand and established name, dosage form, and ingredient information
- Accompany benefit with risk information
- Provide a link to a page devoted “exclusively” to risk information.
If both benefit and risk information can’t be included in the limited space, the company should consider using a different platform, the FDA advises. “The Twitter Guidance provides a fictional example to show that it’s not impossible to produce an acceptable tweet. But it is very difficult,” says Erin M. Bosman, chair of the Product Liability Practice Group at Morrison & Foerster. Companies that go the Twitter route may want to focus on products with only a few risks or
risks that are easy to understand, she says.
Correcting third-party Misinformation
This guidance, called “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices.”
“Companies can breathe a sigh of relief with this guidance because it says companies are not obliged to correct third-party information,” Bosman says. “This reduces the need to monitor and mine massive quantities of Internet data about their products.”
The FDA suggests guidelines for voluntary correction of third-party misinformation, such as posting the correction in the same area or forum where the misinformation is found, when possible. Bosman suggests that companies should have “a standard policy about the type of information to correct. For example, misinformation that presents serious health risks should be a higher priority than correcting more innocuous misinformation.” She also recommends formulating a standard response for correcting common misinformation in order to ensure accuracy and consistency.