To amend the Federal Food, Drug, and Cosmetic Act to restrict direct-to-consumer drug advertising.
Sponsors
Legislative Progress
IntroducedMr. King (for himself, Mr. Welch, and Mr. Kaine) introduced …
Summary
What This Bill Does
This bill restricts pharmaceutical companies from advertising prescription drugs directly to consumers (such as TV commercials or social media ads) for the first three years after a new drug receives FDA approval. The goal is to allow more time for post-market safety data to emerge before drug makers can promote new medications to the general public.
Who Benefits and How
Patients and the general public benefit by being protected from advertising for newly approved drugs before their long-term safety profiles are better understood. This cooling-off period allows time for adverse effects to surface through real-world use before aggressive marketing campaigns drive consumer demand.
Healthcare providers may see fewer patients requesting newly approved drugs based on advertising, allowing more physician-driven prescribing decisions based on clinical evidence rather than marketing influence.
Who Bears the Burden and How
Pharmaceutical companies face significant restrictions on their marketing strategies. They cannot advertise new drugs directly to consumers for three years after approval, which delays their ability to build brand awareness and drive sales through consumer demand. This may reduce revenue projections for newly launched medications.
Drug sponsors must apply for waivers if they want to advertise during the third year, demonstrating that advertising would provide "affirmative value to public health" - a process that adds regulatory burden and uncertainty.
Key Provisions
- 3-year advertising ban: Prohibits direct-to-consumer advertising (including on social media) for any newly approved drug for three years after FDA approval
- Third-year waiver option: Drug sponsors may apply in the third year for a waiver if they can show advertising would benefit public health
- Post-3-year prohibition authority: The Secretary of Health and Human Services can ban advertising even after 3 years if a drug is found to have significant adverse health effects
- Applies to recent approvals: The law applies to drugs approved starting one year before the enactment date
- Rulemaking required: FDA must update its advertising regulations within one year of enactment
Evidence Chain:
This summary is derived from the structured analysis below. See "Detailed Analysis" for per-title beneficiaries/burden bearers with clause-level evidence links.
Primary Purpose
This bill amends the Federal Food, Drug, and Cosmetic Act to restrict direct-to-consumer drug advertising for a period of three years after approval, with provisions for waivers and prohibitions based on health effects.
Policy Domains
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
- "the_secretary"
- → Secretary of Health and Human Services
Key Definitions
Terms defined in this bill
Advertising of a drug directly to consumers, including on social media platforms.
The period beginning on the date of approval of a drug under section 505(c), during which direct-to-consumer advertising is prohibited unless waived.
We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.
Learn more about our methodology