By Kate Greenwood
[Cross-posted at Health Reform Watch]
Earlier this week, the Food and Drug Administration announced that it was reopening the comment periods for the two draft guidances on the use of social media to promote prescription drugs and medical devices that it released in June: 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. Both guidances have drawn criticism from industry and observers, with the FDA being charged with, in the words of Pharmaguy at the Pharma Marketing Blog, “not being technically savvy enough to understand the nuances of social media and search engine advertising.”
In the draft guidance on social media platforms with character space limitations, such as Twitter and sponsored links on Google and Yahoo, the FDA states that “if a firm chooses to make a product benefit claim, the firm should also incorporate risk information within the same character-space-limited communication.” The draft guidance would allow companies to limit the risks that are presented within a character-and-space-limited communication to those that are the most serious, as long as the communication also includes a direct hyperlink to a destination (for example, a landing page) that is devoted exclusively to a complete discussion of the product’s risks. The FDA emphasizes in the draft guidance that “[i]f an accurate and balanced presentation of both risks and benefits is not possible within the constraints of the platform, then the firm should reconsider using that platform for the intended promotional message (other than for permitted reminder promotion).” In the first round of comments, PhRMA commented that the amount of information that companies are required to include in a single communication “would make the use of Twitter and comparable platforms impossible in all but the rarest cases.” With regard to sponsored links, PhRMA also noted that the guidance assumes that advertisers have more control than they in fact do over “the appearance – and order of appearance – of information on such platforms.”
It will be interesting to see whether and how the FDA responds to these comments, as well as to any additional comments filed during the period that comments are reopened, which ends on October 29th. If the agency holds the line (as I think it should) and continues to require that companies provide at least some balance between risks and benefits in all advertising and labeling, regardless of platform, companies will no doubt (continue) to look for alternatives. Read More
