Davar Discusses FDA’s Position on Social Media Drug Promotion
Life Sciences & Healthcare Regulatory practice co-chair Mahnu Davar was quoted in the Corporate Counsel article, “Surge in Social Media Drug Promotion Driving Calls for More Oversight,” which discusses how the rise in social media prescription drug promotions by influencers has increased pressure on the U.S. Food and Drug Administration (FDA) to boost oversight of such promotions.
“I think the industry would like more clarity from the FDA on what exactly its position is on its authority over social media,” Davar told Corporate Counsel. The FDA typically asserts in its enforcement and guidance that if a company holds authorship or control over a prescription drug message, that company could be liable under the Federal Food, Drug, and Cosmetic Act, Davar continued.
Davar noted that “it’s pretty clear” that the Federal Trade Commission has given a lot of thought about this issue and “has the broader jurisdiction” to pursue the enforcement of testimonials and personal statements from individuals. “They (the FTC) are not bound by the same regulatory and statutory definitions that the FDA is about labeling and advertising and intended use. And it’s very clear the two agencies collaborate,” he said. However, Davar added that it is “vexing” that the FDA has not released clearer guidance in this area. He predicted that if the FDA takes more action, it will be based on misleading messages.
With regards to how companies can mitigate risk, Davar noted that it is critical that companies, their regulatory departments, and their lawyers comprehend social media usage and who they are dealing with. “In the prescription drug world where I’ve seen issues pop up, it’s largely because people don’t know enough about the personality that they’re working with,” he said. Failing to align their social media messaging may expose companies to legal scrutiny beyond the oversight of regulatory bodies like the FDA and FTC, Davar cautioned.
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