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Direct-to-consumer advertising of prescription drugs is only completely legal in New Zealand and the United States. In 2022 the pharmaceutical industry spent about $7.6 billion on direct-to-consumer advertising in the United States.[1] As would be expected, many of these advertisements are for widely prescribed but expensive medications.
For direct-to-consumer prescription-drug advertisements sponsored by manufacturers, Food and Drug Administration (FDA) regulations, finalized in 2023...
Direct-to-consumer advertising of prescription drugs is only completely legal in New Zealand and the United States. In 2022 the pharmaceutical industry spent about $7.6 billion on direct-to-consumer advertising in the United States.[1] As would be expected, many of these advertisements are for widely prescribed but expensive medications.
For direct-to-consumer prescription-drug advertisements sponsored by manufacturers, Food and Drug Administration (FDA) regulations, finalized in 2023 after years of delay, establish clear standards for accuracy; the disclosure of major risks, contraindications and benefits; and consumer-friendly language.[2] The FDA’s oversight of television advertisements from telehealth companies and online drug promotions from celebrities and other social media influencers must be improved, however.
In February 2025 Sen. Richard Durbin of Illinois and Sen. Roger Marshall of Kansas, who is a physician, wrote to the FDA about a commercial for compounded weight-loss drugs that was scheduled to air during the Super Bowl. The senators considered the commercial deceptive because there was no disclosure of side effect, “risk, or safety information as would be typically required in a pharmaceutical advertisement.”[3]
The senators’ letter continued:
“By comparison, the FDA-approved labels and advertisements for brand-name GLP-1 medications include significant risk disclosures to patients about side effects and contraindications, including warnings about potential gallbladder, pancreas, vomiting, diarrhea, and other implications. Further, for only three seconds during the minute-long commercial does the screen flash in small, barely legible font, that these products are not FDA-approved.”[4]
Later in February 2025 Durbin and Marshall introduced S. 652, the Protecting Patients from Deceptive Drug Ads Act,[5] to address false and misleading prescription-drug promotions.[6] If enacted, the bipartisan legislation would empower the FDA to send warning letters, followed by fines for noncompliance, to social media influencers and health care providers who make “false and misleading” statements about FDA-approved drugs or compounded drugs. The legislation applies to advertisements as well as promotional communications on a social media platform from which the providers or influencers may financially benefit.
Among other provisions, the legislation would require pharmaceutical manufacturers to report to the federal Open Payments database their payments to telehealth companies and social media influencers, and telehealth companies to similarly report their payments to social media influencers.
Public Citizen has joined other organizations in endorsing the Protecting Patients from Deceptive Drug Ads Act. In my view, it would be preferable if there were either no direct-to-consumer advertising of prescription drugs in the U.S., or no advertisements until a drug had been on the market for at least seven years and its risks and side effects were more fully understood. Absent such fundamental changes, however, the legislation is a constructive step forward in protecting all of us from deceptive drug advertisements.
References
[1] Pharmaceutical industry’s direct-to-consumer (DTC) spending on media in the United States from 2016 to 2022. https://www.statista.com/statistics/317819/pharmaceutical-industry-dtc-media-spending-usa/#:~:text=In%202022%2C%20the%20pharmaceutical%20industry,increase%20of%20almost%20six%20percent. Accessed March 21, 2025.
[2] Steinbrook R. New FDA rules for risk information in direct-to-consumer advertisements for prescription drugs. Worst Pills, Best Pills News. February 2024.
[3] Durbin, Marshall draw FDA attention to misleading drug commercial set to run during Super Bowl. February 7, 2025. https://www.durbin.senate.gov/newsroom/press-releases/durbin-marshall-draw-fda-attention-to-misleading-drug-commercial-set-to-run-during-super-bowl. Accessed March 20, 2025.
[4] Ibid.
[5] S. 652. Protecting patients from deceptive drug ads act. https://www.congress.gov/bill/119th-congress/senate-bill/652/text/is?overview=closed&format=xml. Accessed March 20, 2025.
[6] Durbin, Marshall introduce protecting patients from deceptive drug ads act. https://www.durbin.senate.gov/newsroom/press-releases/durbin-marshall-introduce-protecting-patients-from-deceptive-drug-ads-act. Accessed March 20, 2025.
