Drug, Device Online Misinformation Gets FDA Look After 10 Years

Prescription drug and medical device makers could directly correct claims made by social media influencers or other third parties on unapproved uses of a medical product, under revised draft guidance the FDA issued Monday amid growing concerns on health misinformation online.

The draft guidance, titled “Addressing Misinformation About Medical Devices and Prescription Drugs,” replaces recommendations the Food and Drug Administration issued in June 2014 for medical product manufacturers responding to false or misleading information on social media and other online platforms.

Federal lawmakers, regulatory attorneys, and patient advocates have called on the agency to clarify its authority over social media influencers promoting prescription drugs and other medical products without clear warnings on the risks.

A Bloomberg Law investigation published in December 2023 found the FDA has done little to regulate influencers who may or may not have direct ties to the manufacturers, yet tout their success with medications such as Novo Nordisk A/S’s diabetes medication Ozempic and Pfizer Inc.‘s migraine drug Nurtec ODT to millions of followers. Federal lawmakers cited the investigation in a February letter to the FDA calling on the agency to update its decade-old guidance on social media prescription drug promotion and clarify when its advertising regulations apply to paid social media influencers.

FDA officials have said the agency has the authority to monitor social media posts from physicians or anyone, including influencers, who promote a drug on behalf of a manufacturer or distributor. The agency can encourage, but not legally require, manufacturers to correct online misinformation, the officials said.

The FDA said in the updated guidance that manufacturers of prescription drugs and medical devices may address “implicit or explicit false, inaccurate, or misleading representations of fact about or related to a firm’s approved/cleared medical product” on the internet with a “tailored responsive communication.” The identified misinformation includes communications that either directly mention a specific product, or “false information about an entire class of drugs or category of devices that includes a firm’s approved/cleared medical product.”

A manufacturer may directly respond, for example, to a celebrity promoting a prescription drug in a social media post when the individual provides false or misleading instructions to followers on when they should take the medication for it to be most effective. Misinformation that manufacturers may address also includes inaccurate claims on side effects posted on social media, online blogs, or other internet platforms.

The revised guidance, like the original 2014 version, doesn’t mention specific social media platforms and the functionalities that may vary across each one. The FDA has said that its approach to addressing online misinformation has been focused on developing recommendations that have long-term applicability, rather than on individual platforms.

FDA Commissioner Robert M. Califf has called health misinformation a leading cause of death in the US, but has argued the FDA’s authority in regulating misinformation online is limited. The FDA faced renewed demands to clarify its responsibilities after Califf said at a National Press Club event in February that the agency doesn’t “regulate third parties who start clinics and sell things over the internet.”

The FDA clarified in comments to Bloomberg Law after Califf’s remarks that its advertising “laws may apply to telehealth providers and websites, depending on what activities they undertake and how they are structured.”