WASHINGTON – U.S. Senate Democratic Whip Dick Durbin (D-IL) and U.S. Senator Roger Marshall, M.D. (R-KS) today introduced the Protecting Patients from Deceptive Drug Ads Act, bipartisan legislation that would protect public health and close regulatory loopholes by having the Food and Drug Administration (FDA) address false and misleading prescription drug promotions by social media influencers and telehealth companies.
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The prevalence of online promotions and direct-to-consumer advertisements for prescription drugs—such as weight loss, gastrointestinal, or psychiatric medications—has drastically increased in recent years, notably through influencers and telehealth companies—most recently during the Super Bowl—and on social media platforms such as TikTok and Instagram. FDA oversees manufacturer-sponsored prescription drug advertisements by ensuring that promotions by manufacturers are accurate, risks and benefits are disclosed, and information on the FDA-approved label is shared. However, there is generally a gap in FDA’s oversight when it comes to many advertisements by influencers and telehealth companies. Too many of these promotions provide false information, omit key side effects, or fuel demand for medications that may not be appropriate for a patient.
“The power of social media and the deluge of false and misleading promotions has led to too many young people being exposed to inaccurate and harmful advice that promises quick fixes from certain medications,” said Durbin. “Consumers are at risk of severe and long-lasting side effects when an influencer or telehealth company is profiting off deceptive medical content. Our bipartisan legislation would close FDA loopholes to protect patients from prescription drug advertisements lacking basic safety and accuracy information.”
“With the skyrocketing trend of TV ads and social media influencers promoting new medications, this legislation will ensure that advertising regulations and disclosure standards are applied uniformly and consistently,” said Marshall.
The Protecting Patients from Deceptive Drug Ads Act would address false and misleading prescription drug promotions by having FDA issue warning letters, followed by fines for noncompliance, to influencers and telehealth companies that engage in communications that accrue a financial benefit to the speaker and contain false or inaccurate statements, omit labeling or other key facts regarding a medication, or fail to include traditional risk and side effect disclosures. The legislation includes commonsense exemptions to limit the scope of the legislation to flagrantly deceptive commercial speech.
Additionally, the legislation would require pharmaceutical manufacturers to report payments to influencers to the Open Payments database—similar to the existing disclosure of payments to physicians and other health providers—to shine light on promotional activities, including through celebrities. The legislation would enhance FDA’s visibility of social media promotions by utilizing new analytical tools, enhancing public education, coordinating with the Federal Trade Commission (FTC), and establishing a process to notify drug manufacturers of violative content.
The Protecting Patients from Deceptive Drug Ads Act is endorsed by Generation Patient, American Academy of Pediatrics, American College of Physicians, American Academy of Child and Adolescent Psychiatrists, Doctors for America, Public Citizen, Public Interest Research Group, Light Collective, Young People’s Alliance, and Connecting to Cure Crohn’s and Colitis.
Earlier this month, Durbin and Marshall sent a bipartisan letter to FDA to draw the agency’s attention to an a pharmaceutical advertisement that aired during the Super Bowl to more than 120 million Americans, which misled patients by omitting any safety or side effect information when promoting a specific type of weight loss medication.
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