Bill · H.R. 1632· House(119-HR-1632)
Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025
- Introduced
- 2/26/2025
- Last activity
- 2/26/2025 — Referred to the Committee on Energy and Commerce, and in addition to the Committee on Rules, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- Sponsored by
- Chip Roy
- Cosponsors
- - 1 - 0
- Introduced
- In Committee
What this bill would do
This bill, known as the "Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025," seeks to amend the Federal Food, Drug, and Cosmetic Act. It proposes a system for reciprocal marketing approval for certain drugs, biological products, and devices. Under this plan, products already lawfully marketed in specific countries or the United Kingdom may be granted approval in the United States. Eligibility requires demonstrating a public health or unmet medical need and ensuring the product has not been withdrawn due to safety concerns. The Secretary is required to issue a decision within 30 days of receiving a request.
Yes
Does this make health care easier to get in general?+6
The bill streamlines the approval process for foreign drugs and devices to address unmet medical needs in the United States.
Does this make what the government does easier for the public to see?+4
The bill requires the Secretary to submit a monthly list of denied reciprocal marketing approval requests to Congress.
The opposite
No question was scored the opposite.
Who it would affect, and how
Potential Positive Impacts for People
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Meeting Unmet Medical Needs: The bill allows for the approval of products that address a "public health or unmet medical need in the United States" (Section 2(b)(2)(F)).
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Streamlined Access to Foreign Products: Products that are already "lawfully marketed in one or more of the countries included in the list under section 802(b)(1) or in the United Kingdom" may gain approval in the U.S. (Section 2(b)(2)(A)).
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Safety Oversight: The Secretary maintains the power to decline approval if a drug is "not safe and effective" or a device lacks a "reasonable assurance of safety and effectiveness" (Section 2(c)(1)(A)).
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Postmarket Monitoring: The Secretary can require "specified postmarket studies" to ensure continued safety and effectiveness (Section 2(c)(1)(B)).
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Increased Outreach: The Secretary is directed to conduct an "outreach campaign" to encourage eligible sponsors to request reciprocal approval (Section 2(j)).
Potential Negative Impacts for People
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Potential for Safety Risks: While the Secretary has oversight, the bill provides a mechanism for products to be granted approval based on foreign marketing status, which could involve products that are "not approved or cleared for marketing" in the U.S. yet (Section 2(b)(2)(B)).
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Congressional Disapproval Process: A decision by the Secretary to decline approval can be overturned by a "joint resolution of disapproval," which would force the reciprocal marketing approval to take effect (Section 2(g)(3)).
Groups and Interests Ranking
Every group the model scored this bill for, from -10 to +10. Hover a score for the reason it gave.
- Healthcare
- Improves Healthcare Access+6
- Governance And Ideology
- Improves Government Transparency+4
- 2/27/2025
- 1 Cosponsor added.
- 2/26/2025
- Referred to the Committee on Energy and Commerce, and in addition to the Committee on Rules, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- Introduced in House
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.
Andy HarrisRepublican · Maryland