WASHINGTON – U.S. Senate Majority Whip Dick Durbin (D-IL) and U.S. Senator Mike Braun (R-IN) urged the Food and Drug Administration (FDA) to take swift action to update its enforcement tools to reflect the current social media platforms and tactics used to promote prescription drugs, and to prioritize the protection of children from harmful and inaccurate medical advice. With the dramatic rise in social media use—especially among youth—there has been an alarming proliferation of dangerous and misleading content promoting prescription drugs. The bipartisan pairing of Senators request answers from FDA on their actions to crack down on these targeted ads by March 27, 2024.
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The Senators wrote, “Studies show that patients are more likely to ask their provider for a particular medication and to receive a prescription if the patient has seen a direct-to-consumer (DTC) advertisement for the drug. This can inflate demand for medications that may not be clinically appropriate, or for which alternative interventions may be available. DTC ads making product claims for disease treatment are only permitted in the United States and New Zealand, and the appeal and potency of DTC ads demand adequate FDAoversight. Unfortunately, it appears there are gaping holes in FDA’s oversight of DTC promotions that are being exploited on social media at the expense of children and patients.”
FDA has not updated its draft guidance on prescription drug promotion for social media since 2014. The social media landscape has evolved dramatically with the skyrocketing amount of time that users—particularly children—spend scrolling on platforms, and the emergence of platforms such as Instagram, Snapchat, X, and TikTok.
The Senators continued, “While we recognize FDA has conducted initial research in this space and supported a one-day workshop, the agency’s decade-old guidance must be modernized. FDA’s guidance needs to clarify that these platforms are subject to its jurisdiction and should reflect the way that advertisements on these platforms must comply with federal requirements—such as conspicuousness and duration of statements, and size/contrast of imagery, including accounting for character counts and other limitations.”
According to a Wall Street Journal (WSJ) article, telehealth companies have engaged in extensive social media promotion for prescription drugs—without adhering to traditional requirements on accuracy, side effect disclosures, and fair balance of risk information. During a four-week period in 2022, the WSJ found more than 1,800 social media ads promoting prescription drugs without warnings or risks, and 500 ads for product uses that FDA did not approve.
There has been an explosion of prescription drug promotion by social media influencers, including celebrities, content creators who fail to disclose a financial relationship with a drug’s manufacturer, and those with no financial relationship. Often, influencers hold a degree of trust with followers, giving the impression of expertise on a given subject. Consumers can be inundated with promotions for medications from influencers with no expertise, and whether or not the influencer has ever used the medication. Such ads often overstate benefits and minimize harms. Warranting particular attention is the interaction between influencers and their followers via public comment sections—which can further evade appropriate safeguards.
“The power of social media and the deluge of misleading promotions has meant too many young people are receiving medical advice from influencers instead of their health care professional. Only seven of FDA’s publicly available warning and untitled letters issued since 2017 relate to social media content,” the Senators continued. “The threats to children from misleading and unsubstantiated advertisements necessitate action. You have called health misinformation and disinformation a leading cause of death in the United States—and it is time the FDA addresses this challenge.”
Text of the letter can be found here.
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