Senators Pen Letter to FDA Urging Stronger Enforcement on Deceptive Direct-to-Consumer Social Media Ads Promoting Prescription Drugs

Image Credit: Adobe Stock Images/Tanya Keisha

Last week, US Senators Richard Durbin and Mike Braun issued a letter to the FDA stressing the importance of updating and enforcing regulations against misleading social media advertisements for prescription drugs. According to the letter, the senators pointed out the substantial influence that direct-to-consumer (DTC) advertisements have on patient medication demands, especially on social media platforms such as Instagram, Snapchat, X/Twitter, and TikTok. At this time, the FDA hasn’t made any guideline updates regarding social media since 2014, making it outdated in light of the evolving digital landscape and the increasing time children spend on these platforms.¹

“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,” wrote the senators. “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 FDA oversight. 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.”

Additionally, the senators pointed out the significant amount of prescription drugs promoted via social media, especially by celebrities and content creators, who they said often fail to disclose financial connections with a drug’s manufacturer.¹

“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 letter continued.¹

The letter goes on to press the FDA to respond to a number of questions by March 27. As a result of the implications raised by such misleading promotions on public health, particularly among a younger population, Durbin and Braun are pressing the FDA for a comprehensive update to its regulatory framework to address these challenges effectively.¹

“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,” the senators concluded.

In an article published last year by the John Hopkins Bloomberg School of Public Health, epidemiology professor Caleb Alexander and senior associate Thomas Moore highlight the dangers posed by these advertisements, especially to vulnerable populations seeking treatments for serious conditions. According to the experts, unregulated ads often make false claims or misrepresent evidence regarding the efficacy and safety of drugs, including those not approved by the FDA for certain uses.

The pair said that as a result of the shutdowns caused by the COVID-19 pandemic, advertising for DTC products grew significantly, even if they weren’t approved by the FDA. Entities directly involved in manufacturing, distributing, or packing prescription drugs, leaving a significant gap that allows other companies, including telemedicine start-ups and clinics, to promote prescription drugs without adhering to strict advertising standards.²

“It’s not fair, reasonable, nor practicable to expect consumers to be able to sort through these misrepresentations—and I don’t believe it’s the system that was intended. It’s time to close the loophole that is allowing this to happen,” said Alexander, speaking on what can be done to protect consumers. “Companies that are marketing and promoting these drugs should be held to the same standards as drug manufacturers, whether or not they are the ones actually producing the product. When it comes to the risks of false advertising, and the threat that it poses to public health, there is nothing fundamentally different between a telemedicine start-up making outlandish claims and such claims arising from the drug maker itself.”

References

1. Durbin, Braun Urge FDA To Crack Down On Misleading Social Media Ads That Promote Prescription Drugs. Durbin.Senate.gov. February 15, 2024. Accessed February 22, 2024. https://www.durbin.senate.gov/newsroom/press-releases/durbin-braun-urge-fda-to-crack-down-on-misleading-social-media-ads-that-promote-prescription-drugs

2. A Perilous Prescription: The Dangers of Unregulated Drug Ads. John Hopkins. March 2, 2023. Accessed February 22, 2024. https://publichealth.jhu.edu/2023/the-dangers-of-unregulated-drug-ads