Protecting Children from Experimentation Act of 2025

House Bill

H.R. 3688

119th Congress

Protecting Children from Experimentation Act of 2025

In Committee

Introduced:Jun 3, 2025

Primary Sponsor

Doug LaMalfa

Representative

Republican

CA-1

Cosponsors

0

Quick Stats

Policy Area

Health

Summary

This bill gives the Food and Drug Administration (FDA) more power to order drug companies to recall unsafe or mislabeled medications. It requires drug producers to notify the FDA if they believe a drug is unsafe, and the FDA can then order the company to stop selling it and notify affected people. The FDA can also order an immediate recall if a drug poses an immediate threat to people's health.

Latest Action

Referred to the Subcommittee on Health.

SponsorDoug LaMalfa (R-CA)

Introduced6/3/2025

StatusReferred to the House Committee on the Judiciary.

ChamberHouse

Data from Congress.gov

See this page through your district lens

Enter ZIP to personalize representatives and vote context.

Stay on top of this issue

Subscribe for weekly bill and representative updates.

Vote Prediction

Protecting Children from Experimentation Act of 2025

This bill gives the Food and Drug Administration (FDA) more power to order drug companies to recall unsafe or mislabeled medications. It requires drug producers to notify the FDA if they believe a drug is unsafe, and the FDA can then order the company to stop

Community Breakdown

Pass

0%

Fail

0%

0 predictions

This bill gives the Food and Drug Administration (FDA) more power to order drug companies to recall unsafe or mislabeled medications. It requires drug producers to notify the FDA if they believe a drug is unsafe, and the FDA can then order the company to stop selling it and notify affected people. The FDA can also order an immediate recall if a drug poses an immediate threat to people's health.

Bill Number: 3688
Sponsor: Doug LaMalfa (R-CA)
Introduced: 6/3/2025
Status: Referred to the House Committee on the Judiciary.
Policy Area: Health

Data from Congress.gov

AI-generated summary

Fact Sheet

Title: Protecting Children from Experimentation Act of 2025
Bill Number: 3688
Sponsor: Doug LaMalfa (R-CA)
Status: Referred to the House Committee on the Judiciary.
Introduced: 6/3/2025
Summary: This bill gives the Food and Drug Administration (FDA) more power to order drug companies to recall unsafe or mislabeled medications. It requires drug producers to notify the FDA if they believe a drug is unsafe, and the FDA can then order the company to stop selling it and notify affected people. T

Data from Congress.gov

AI Summary

Plain-English explanation of this bill

This bill gives the Food and Drug Administration (FDA) more power to order drug companies to recall unsafe or mislabeled medications. It requires drug producers to notify the FDA if they believe a drug is unsafe, and the FDA can then order the company to stop selling it and notify affected people. The FDA can also order an immediate recall if a drug poses an immediate threat to people's health.

Last updated: 12/30/2025

Official Summary

Congressional Research Service summary

Recall Unsafe Drugs Act of 2023 This bill authorizes the Food and Drug Administration (FDA) to order the recall of certain adulterated or misbranded drugs and contains other related provisions. A producer of a medication must notify the FDA of the identity and location of a drug if the producer has reason to believe that (1) the drug is adulterated or misbranded, and (2) there is a reasonable probability that the drug will cause a threat of serious adverse health consequences or death to humans or animals. If use of a drug may cause serious adverse health consequences or death, the FDA may order the producer to immediately cease distribution and notify affected individuals. After issuing such an order, the FDA may also order a recall after affording the producer an opportunity for an informal hearing. If a drug presents an imminent threat of serious adverse health consequences or death, the FDA may order the producer to immediately recall the drug and notify affected individuals. The distributor may appeal such an order. An individual or entity required to register as a producer of drugs or medical devices must have a recall plan in effect.

Key Points

Main provisions of the bill

Allows the FDA to order drug recalls if a medication is adulterated, misbranded, or poses a serious health threat
Requires drug producers to notify the FDA if they believe a drug is unsafe
Authorizes the FDA to order an immediate recall if a drug presents an imminent threat to health
Mandates that drug producers have a recall plan in place

How This Impacts Americans

Potential effects on citizens and communities

This bill would give the FDA more tools to quickly pull unsafe or mislabeled drugs off the market and notify the public. It would impact drug producers, who would have to be more vigilant about monitoring drug safety and have recall plans ready. Consumers would benefit from faster action to remove dangerous medications from the supply.

Policy Areas

Primary Policy Area

Health

Related Subjects

Administrative remedies

Consumer affairs

Department of Health and Human Services

Drug safety, medical device, and laboratory regulation

Government information and archives

Scope & Jurisdiction

Jurisdiction Level

federal

Congressional Session

119th Congress

Citation Reference

3688, 119th Congress (2025). "Protecting Children from Experimentation Act of 2025". Source: Voter's Right Platform. https://votersright.org/bills/118-hr-3688