Drug and device companies received some preliminary guidance from the Food and Drug Administration (FDA) on how they should communicate about their products online. FDA recently provided this information in two draft guidance documents. The first guidance advises industry on how it should present risk and benefit information for medical devices or prescription drugs on Internet/social media platforms that have character space limitations. This includes online paid search engines such as Yahoo or Google or sites like Twitter.
Firms that communicate benefit information on such platforms should ensure that the material isn’t misleading and is presented accurately. Once that’s accomplished, the next consideration is whether “enough capacity will remain in the character-space-limited communication to adequately convey required risk information,” the draft guidance states.
“We understand that communicating on electronic Internet sites with character space limitations can be challenging. But, no matter the Internet source used, benefit claims in product promotions should be balanced with risk information,” explained Thomas Abrams, director of the FDA’s Office of Prescription Drug Promotion in its Center for Drug Evaluation and Research, in a blog post.
According to FDA spokesperson Tara Goodin, “the firm should also provide a mechanism to allow direct access to a more complete discussion of the risks associated with its product.”
If platform constraints make it too difficult to provide an accurate and balanced presentation of both the risks and benefits of a specific product, then the firm might want to reconsider using that platform for its intended promotional message—although it might be sufficient for “reminder” promotions, Goodin says.
The second guidance describes how companies can respond to and correct independent third-party misinformation about their prescription drugs and medical devices that appears on the Internet or through social media.
“The Internet and Internet-based technologies have made it easier for third parties who are independent of firms to disseminate information about drugs and devices,” the draft guidance stated. Such information, which the FDA refers to as “user-generated content,” may not consistently be accurate and could be potentially harmful from a public health standpoint.
In approaching a third party about correcting misinformation, drug and device companies should support their claim with sufficient evidence and demonstrate consistency with FDA-required labeling for the product in question, the agency’s draft guidance advised. In addition, they should be prepared to disclose that the individual supplying the corrective information “is affiliated with the firm that manufactures, packs, or distributes the product,” according to the draft guidance statement.
Given the vast amount of information on Internet and social media platforms, “it may be difficult for a company to correct all misinformation about its products in one forum,” Goodin acknowledges.
Drug and device firms are not expected to correct every error on an entire social media platform, in the event they find one or more occurrences of misinformation. “However, a company should clearly identify the misinformation it is correcting, define the portion of the forum it is correcting, and should correct all the misinformation that appears in that clearly defined portion,” Goodin says.