Bill · S. 3081· Senate(119-S-3081)
Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025
- Introduced
- 10/30/2025
- Last activity
- 10/30/2025 — Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Sponsored by
- Ted Cruz
- Cosponsors
- - 1 - 0
- Introduced
- In Committee
What this bill would do
This bill is known as the Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025. It amends the Federal Food, Drug, and Cosmetic Act to allow for reciprocal marketing approval of certain drugs, biological products, and devices. Under this bill, a product can receive approval in the United States if it is already lawfully marketed in specific foreign countries or the United Kingdom, provided there is an unmet medical or public health need. The Secretary of Health and Human Services must grant or decline this approval within 30 days of receiving a request. If the Secretary declines a request, Congress can potentially overturn that decision through a joint resolution of disapproval.
Yes· 3 of 15
Does this make health care easier to get in general?+7
Accelerates patient access to life-saving treatments by allowing reciprocal marketing approval for products already approved in trusted foreign nations.
Would people over 65 be better off under this?+4
Seniors often experience a higher incidence of unmet medical needs, making faster access to breakthrough drugs particularly impactful.
Would people with disabilities be better off under this?+4
Accelerates access to assistive medical devices and specialized therapies for individuals with disabilities.
The opposite
Does this give the federal government more power?-3
Expands congressional oversight authority via joint resolutions of disapproval over FDA drug and device decisions.
Who it would affect, and how
Potential Positive Impacts for People
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Section 2, adding new section 524C(b), allows for reciprocal marketing approval of drugs, biological products, and devices if there is a public health or unmet medical need in the United States and the product is lawfully marketed in specific foreign countries or the United Kingdom. This could help people gain faster access to necessary medical treatments.
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Section 2, adding new section 524C(j), requires the Secretary to conduct an outreach campaign to encourage sponsors of potentially eligible covered products to request reciprocal marketing approval. This may help bring beneficial medical products to the attention of the U.S. market more quickly.
Potential Negative Impacts for People
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Section 2, adding new section 524C(c)(1)(A), allows the Secretary to decline approval only if they affirmatively determine a drug is not safe and effective or a device lacks a reasonable assurance of safety and effectiveness. If safety issues are missed, individuals could face risks from products approved under foreign standards.
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Section 2, adding new section 524C(c)(1)(B), permits the Secretary to condition reciprocal marketing approval on the conduct of specified postmarket studies or risk evaluation and mitigation strategies. This indicates that products may enter the market before all potential long-term safety questions are fully answered, placing the burden of monitoring on postmarket studies.
Groups and Interests Ranking
Every group the model scored this bill for, from -10 to +10. Hover a score for the reason it gave.
- Demographic And Interest Groups
- Good For People With Disabilities+4Good For Retirees+4Good For Seniors+4Good For Business Owners+3Good For Children+3Good For Middle Aged+3Good For Young Adults+3Good For Low Income Households+2Good For Middle Class Households+2Good For Veterans+2Good For Women+2
- Healthcare
- Improves Healthcare Access+7
- National Security And Foreign Policy
- Improves International Alliances+3
- Economy And Finance
- Improves Small Business Support+2
- Governance And Ideology
- Improves Government Transparency+2Increases Federal Power-3
- 10/30/2025
- Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- 1 Cosponsor added.
- Introduced in Senate
One bill Congress.gov lists as related to this one — companions in the other chamber, earlier versions, and bills this one absorbed or was folded into.
Mike LeeRepublican · Utah