Protecting Patients from Deceptive Drug Ads Act
The Protecting Patients from Deceptive Drug Ads Act would substantially broaden the U.S. government’s oversight of prescription-drug promotion on social media and through telehealth channels. It creates a new prohibition on false or misleading promotional communications about drugs that are advertised or promoted by social media influencers or health care providers, with civil penalties for violations. It also requires public disclosure of certain payments tied to such promotions, expands FDA authority to monitor and regulate digital advertising of prescription drugs (including via AI-enabled market surveillance), and strengthens coordination between the FDA and FTC. The bill would also tighten rules around telehealth advertising by clarifying who may be considered a drug advertiser in this context and directing the Secretary to update regulations accordingly. A funding package of up to $15 million per year (2025–2029) is provided to support these activities. The act is currently introduced and not yet enacted.
Key Points
- 1Prohibition and penalties for false or misleading drug communications by social media influencers and health care providers, including statements made knowingly or recklessly or omissions of required safety and effectiveness information; requires alignment with the brief summary information standard in 502(n) for prescription drug ads.
- 2Clear definition of “social media influencer” and a broad description of what counts as false or misleading communications; exclusions for bona fide patient care, medical research statements, and personal experiences or value judgments.
- 3Secretary-level guidance within 180 days on how to determine false/misleading communications, the sufficiency of brief summaries, compliance actions, and platform-specific considerations.
- 4Telehealth advertising provisions expanded: definitions to include certain promotional activities by manufacturers, packers, or distributors that facilitate connections between patients and prescribers; requires regulatory updates within 1 year.
- 5Rule of construction preserving drug manufacturers’ ability to take corrective action to mitigate patient harm from deceptive communications.
- 6Reporting requirements: payments related to promotion of covered drugs (between manufacturers/providers and influencers or vice versa) must be reported to HHS and publicly disclosed, tied to the existing 1128G transparency framework.
- 7Market surveillance and enforcement: FDA may conduct surveillance of social media promotion, use AI analytics, engage with platforms, and establish an interagency task force with the FTC; staff expansion for relevant FDA offices; and regular reporting to Congress on enforcement and activities.
- 8Funding and timelines: authorizes $15 million per fiscal year 2025–2029 to support market surveillance and related activities; several provisions take effect 180 days after finalizing the related regulations.