Bill would allow the FDA to fine individuals, companies up to $500,000 for posting false information online about Ozempic, Wegovy
Two U.S. senators are aiming to crack down on deceptive or misleading online promotion of weight-loss and other prescription drugs by telehealth firms and social-media influencers who profit from their posts.
New bipartisan legislation proposed by Sens. Dick Durbin (D., Ill.) and Mike Braun (R., Ind.) would authorize the Food and Drug Administration to warn and potentially impose costly fines on those who post false information online about medicines, or omit important information about a drug’s safety risks.
One impetus for the bill, according to a Senate aide, is the 2024 reporting by The Wall Street Journal about how social media has fueled demand for Ozempic and Wegovy from Novo Nordisk as well as other drugs used for weight loss. The Journal found that posts on platforms such as TikTok, YouTube and Instagram often omit information about difficult side effects, and that some influencers and companies profit from the posts.
As with company drug advertisements, social-media posts sponsored by drug manufacturers are required by the FDA to cite the risks. But the senators say there is a regulatory gap in FDA oversight when it comes to advertisements from telehealth companies and influencers if there isn’t an established relationship with a drug manufacturer.
Durbin and Braun earlier this year called on the FDA to take action against the marketing of prescription drugs on social media, citing a proliferation of dangerous and misleading content by telehealth companies. Their letter to the FDA commissioner cited findings from a Journal investigation published in 2022 about misleading ads by telehealth companies.
When faced with the criticism, some telehealth firms have said that they provide safety information to patients and have procedures to vet the accuracy of posts by influencers with whom they work.
The new bill, “Protecting Patients from Deceptive Drug Ads Online Act,” says too many social-media posts provide false information, omit key side effects, or fuel demand for medications that might not be appropriate for a patient.
The bill aims to give the FDA authority to require drugmakers to disclose payments to influencers to the federal Open Payments database, as they currently do with payments to physicians and other health providers.
The FDA would also have the authority to issue warning letters to influencers and telehealth companies for deceptive and misleading promotions. Those who don’t comply with the warning letters would face fines of up to $250,000 for the first violation in any three-year period, and up to $500,000 for each subsequent violation in any three-year period.
The FDA enforcement would apply to online posts that yield a payment to the influencer or telehealth firm and contain false statements, omit facts regarding a prescription drug, or fail to include traditional risk and side effect disclosures.
It would exempt certain statements that occur in the course of bona fide patient care or describe someone’s personal experience.
The legislation would work similarly to the way the FDA oversees drug advertisements from manufacturers. The agency requires drugmakers to accurately describe the FDA-approved use for the drug, as well as its major side effects, and to direct patients to where they can learn more, like a website.
The FDA sends warning letters to companies if it deems an ad to be misleading, and they can face fines of up to $250,000 for the first violation.
Source: Wall Street Journal
