On February 20, 2025, U.S. Senators Dick Durbin (D-IL) and Roger Marshall, M.D. (R-KS) introduced bipartisan legislation, the Protecting Patients from Deceptive Drug Ads Act (the Act), which closes perceived “legal loopholes” in social media advertisements by telehealth companies. The Act would require the U.S. Food & Drug Administration (FDA) to target false and misleading prescription drug promotions by social media influencers and telehealth companies.
背景
Whether or not telehealth companies are under FDA jurisdiction when marketing and promoting prescription drugs has been under debate since The New York Times published its 2019 article, Drug Sites Upend Doctor-Patient Relations: ‘It’s Restaurant-Menu Medicine’. The report called into question whether telehealth companies are — or ought to be — subject to FDA oversight when advertising drugs and medical devices. Subsequent investigative reporting alleged how some telehealth companies ran ads on social media describing benefits of prescription drugs but failing to describe the risks of these drugs. Reporters claimed telehealth companies promoted drugs for unapproved uses or featured “testimonials” without disclosing whether or not the testimonials came from actual patients or were from paid actors or company employees.
Under the Federal Food, Drug, and Cosmetic Act (FDCA), advertisements for prescription drugs may not be false, lacking in fair balance, or otherwise misleading. Any advertisements for prescription drugs (with the narrow exception of exempt reminder ads), must present a true statement of information in brief summary relating to side effects, contraindications, and effectiveness. The term “side effects, contraindications” means side effects, warnings, precautions, and contraindications, and also includes any such information under such headings as cautions, special considerations, important notes, etc.
Some have claimed these FDCA legal requirements, although clearly applicable to drug manufacturers, packers, and distributors, do not apply to telehealth companies and associated medical providers because the telehealth company and their associated providers are not addressed in the FDCA and not included in the definition of “firm” under applicable FDA Guidance documents. Under this argument, telehealth companies and their associated providers are not subject to these drug advertising laws in their direct-to-consumer marketing campaigns. Former FDA Commissioner Robert Califf observed how a number of online advertisements by telehealth companies fail to give the complete risk-benefit story (something drug manufacturers must do), as he noted how the FDA lacks the legal authority to regulate the advertising activities of such telehealth companies.
次に何をする？
If signed into law, the Protecting Patients from Deceptive Drug Ads Act would extend FDA’s jurisdiction to specifically include market surveillance of social media influencers and health care providers for whom a financial benefit exists when such communications contain false or inaccurate statements, omits labeling or other key facts regarding a medication, or fails to include traditional risk and side effect disclosures. The Act authorizes FDA to issue warning letters and civil penalties for non-compliance.
The Act is a bipartisan effort and the controversy surrounding telehealth advertising of prescription drugs is not new. We do not anticipate this issue will fade away soon, although similar legislation previously proposed did not pass. Whether this bill can garner sufficient support remains to be seen. What is clear is there is a growing concern among federal policymakers about what they consider unsafe and imbalanced advertisements for prescription drugs by telehealth companies. Given this climate, a best practice is to ensure advertisements and marketing campaigns are reviewed by skilled advisors who can maintain the effective impact of direct-to-consumer promotions while reducing the legal risk of non-compliant advertising campaigns. As the Act moves through Congress, we will provide updates.
もっと知りたいですか？
- Regulation of Digital Health Products by FDA
- FDA’s Final Rule on Direct-to-Consumer Advertising – Presentation of Risk Information
- DTC Promotional Labeling and Advertisements: Quantitative Efficacy Wins Over FDA in Final Guidance on Presenting Risk Information
- 医療製品の未承認用途に関する科学的情報：医療提供者への企業コミュニケーションに関するFDAの最終ガイダンス
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