Responsibility in Drug Advertising Act of 2025 | ChamberLight

IN COMMITTEE· 119TH CONGRESS

House BillHR 1117Drug safety, medical device, and laboratory regulationBroadcasting, cable, digital technologies

Responsibility in Drug Advertising Act of 2025

INTRO FEB 7· LAST ACTION FEB 7

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Introduced

In Committee

Reported

Passed House

Passed Senate

Conference

To President

Became Law

WHAT THE BILL DOES

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This bill matters because it changes how Americans learn about new medications and how pharmaceutical companies market them. If it becomes law, it means that for three years after a drug is approved, you won't see ads for it on TV, online, or on social media. This could mean fewer patients asking their doctors for specific new drugs they've seen advertised, potentially allowing doctors to make treatment decisions based purely on medical information rather than patient requests driven by advertising.

Voters should care because it addresses concerns about patient safety and the influence of advertising on healthcare decisions. Supporters believe it gives more time for the full safety profile of a drug to become known before it's widely promoted, while critics worry it could limit public awareness of important new treatments. This bill also gives the FDA more power to pull ads for drugs if significant safety issues emerge, shifting the balance of power in drug communication.

KEY PROVISIONS

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PROVISION 01

Prohibits direct-to-consumer advertising for newly approved drugs for three years after their approval.

This ensures that a drug's safety and effectiveness can be more thoroughly understood by medical professionals and the public before widespread advertising begins.

PROVISION 02

Allows the FDA to grant a waiver for advertising during the third year of the ban if it determines that advertising would have an 'affirmative value to public health'.

This provides flexibility to allow early advertising for critical drugs where public awareness is deemed essential for health outcomes.

PROVISION 03

Authorizes the FDA to prohibit advertising for a drug even after the three-year period if significant adverse health effects are identified post-approval.

This gives the FDA ongoing power to protect public health by stopping advertising for drugs that are later found to have serious risks.

PROVISION 04

Requires the FDA to update its regulations governing drug advertisements within one year of the bill's enactment to implement these new rules.

This ensures that the legal framework for drug advertising is aligned with the new restrictions proposed by the bill.

SPONSORSHIP

1 + 0

ACTION TIMELINE

2 EVENTS

FEB 7

Introduced in House

INTROREFERRAL

FEB 7

Referred to the House Committee on Energy and Commerce.

HOUSE · INTROREFERRAL

BILL INFO

TypeHouse Bill

NumberHR 1117

Congress119th

StatusIn Committee

IntroducedFeb 7, 2025

Last actionFeb 7, 2025

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IN COMMITTEE· 119TH CONGRESS · ENERGY AND COMMERCE COMMITTEE · INTRODUCED FEB 7, 2025

House BillHR 1117Drug safety, medical device, and laboratory regulationBroadcasting, cable, digital technologies

Responsibility in Drug Advertising Act of 2025

INTRODUCED FEB 7, 2025· LAST ACTION FEB 7, 2025

PASSAGE CHANCES

—%

READING

3 min

COSPONSORS

COMPLEXITY

Moderate

Call my reps

LEGISLATIVE PROGRESS

STEP 2 OF 8

Introduced

In Committee

Reported

Passed House

Passed Senate

Conference

To President

Became Law

Introduced
In Committee
Reported
Passed House
Passed Senate
Conference
To President
Became Law

WHAT THE BILL DOES

AI-written

KEY PROVISIONS

AI-extracted

high

Prohibits direct-to-consumer advertising for newly approved drugs for three years after their approval.

This ensures that a drug's safety and effectiveness can be more thoroughly understood by medical professionals and the public before widespread advertising begins.

med

Allows the FDA to grant a waiver for advertising during the third year of the ban if it determines that advertising would have an 'affirmative value to public health'.

This provides flexibility to allow early advertising for critical drugs where public awareness is deemed essential for health outcomes.

high

Authorizes the FDA to prohibit advertising for a drug even after the three-year period if significant adverse health effects are identified post-approval.

This gives the FDA ongoing power to protect public health by stopping advertising for drugs that are later found to have serious risks.

med

Requires the FDA to update its regulations governing drug advertisements within one year of the bill's enactment to implement these new rules.

This ensures that the legal framework for drug advertising is aligned with the new restrictions proposed by the bill.

DEADLINES & DATES

AI-extracted

An AI model extracted this from the bill’s official record and can make mistakes. Check the official text ↗ (opens in new tab)

Not later than 1 year after the date of enactment

Secretary must revise regulations governing drug advertisements.

On or after the date that is 1 year before the date of enactment

New rules apply to drugs approved under section 505(c).

PENALTIES & ENFORCEMENT

AI-extracted

An AI model extracted this from the bill’s official record and can make mistakes. Check the official text ↗ (opens in new tab)

TYPE	AMOUNT	WHO
Civil/Criminal	Subject to existing fines and imprisonment as outlined in section 303 (21 U.S.C. 333) of the Federal Food, Drug, and Cosmetic Act for violations of prohibited acts.	Any person or entity, including drug sponsors, who conducts direct-to-consumer advertising in violation of the new section 506M.

GLOSSARY

AI-written

Direct-to-consumer advertising (DTC): Advertising of prescription drugs directly to the public, typically through television, print, or online media, rather than exclusively to healthcare professionals.
Federal Food, Drug, and Cosmetic Act (FDCA): The primary law governing the safety and labeling of food, drugs, cosmetics, and medical devices in the United States, enforced by the FDA.
Drug sponsor: The company or entity that develops a drug and seeks its approval from the FDA, and is responsible for its marketing.
Secretary: In the context of the Federal Food, Drug, and Cosmetic Act, this refers to the Secretary of Health and Human Services, who oversees the Food and Drug Administration (FDA).
Waiver: An official decision to set aside a specific requirement or rule for a particular case, usually under certain conditions.
Post-approval studies: Research and surveillance conducted after a drug has been approved and is available on the market, to gather more information about its safety, effectiveness, or optimal use.

ACTION TIMELINE

2 EVENTS

FEB 7, 25

Introduced in House

INTROREFERRAL

FEB 7, 25

Referred to the House Committee on Energy and Commerce.

INTROREFERRAL

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Feb 7, 2025

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Responsibility in Drug Advertising Act of 2025

LEGISLATIVE PROGRESS

WHAT THE BILL DOES

KEY PROVISIONS

SPONSORSHIP

ACTION TIMELINE

BILL INFO

READER REACTIONS

Discussion

Responsibility in Drug Advertising Act of 2025

LEGISLATIVE PROGRESS

WHAT THE BILL DOES

KEY PROVISIONS

DEADLINES & DATES

PENALTIES & ENFORCEMENT

GLOSSARY

ACTION TIMELINE

SPONSORS

READER REACTIONS

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Discussion

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