PlainBillCongress, translated.Legislation. Context. Public interest.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.
Congressional Research Service
Version 00 · Introduced in House · Feb 26, 2025
Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025
This bill establishes a reciprocal marketing approval process that allows for the sale of a drug, biological product, or medical device that has not been approved by the Food and Drug Administration (FDA) if the product is approved for sale in another country and there is an unmet need for the product.
Specifically, in order to receive reciprocal approval, the bill requires the product's sponsor to demonstrate, among other things, that (1) the product has been approved in one of the countries specified in the bill, (2) neither the FDA nor any of the specified countries have withdrawn approval for the product because of safety or effectiveness concerns, and (3) there is a public health or unmet medical need for the product.
Showing the opening paragraphs of the official summary.
The FDA may decline approval if it determines that the product is not safe or effective. The FDA may condition reciprocal approval on the conduct of postmarket studies.
The FDA must issue a decision on whether to grant a request for reciprocal marketing approval within 30 days of receiving the request.
Congress may pass a joint resolution to grant reciprocal marketing approval of a product that the FDA declines to approve through the reciprocal process.
People & committees
Rep. Roy, Chip [R-TX-21] · R–TX
Legislative record
A procedural vote is different from passage. Passage in one chamber does not establish enactment. Explore the glossary.
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.
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
Introduced in House
Primary sources
Text links open the official source. We also preserved the text version used in the PlainBill explanation below.
Source last updated: Jan 21, 2026. Consult Congress.gov for the current record.
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Analyze H.R.1632 as objectively as possible. Explain its main provisions, who would be affected, possible benefits and harms, implementation, exceptions, and uncertainties. Present the strongest arguments for and against it, and identify evidence needed to assess its public impact.
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PlainBill explanation
Based on the full Introduced in House · 2025-02-26 text. This explanation has not received human editorial review. This overview describes the proposal’s major provisions; it does not establish what its real-world effects would be.
H.R. 1632 would create a route to U.S. marketing approval for drugs, biological medicines, and medical devices already authorized in certain foreign countries. Sponsors would need to show a U.S. public health or unmet medical need and meet other eligibility requirements. The administering Secretary would have 30 days to decide and could deny approval on specified safety or effectiveness grounds or require studies after marketing. Congress could override a denial through an enacted joint resolution, causing approval to take effect.
(k) Covered product defined In this section, the term covered product means a drug, biological product, or device.
(A) the covered product is authorized to be lawfully marketed in one or more of the countries included in the list under section 802(b)(1) or in the United Kingdom;
(F) there is a public health or unmet medical need for the covered product in the United States.
(c) Safety and effectiveness (1) In general The Secretary— (A) may decline to grant reciprocal marketing approval under this section with respect to a covered product if the Secretary affirmatively determines that the covered product— (i) is a drug that is not safe and effective; or (ii) is a device for which there is no reasonable assurance of safety and effectiveness; and (B) may condition reciprocal marketing approval under this section on the conduct of specified postmarket studies, which may include such studies pursuant to a risk evaluation and mitigation strategy under section 505–1.
The Secretary shall issue an order granting, or declining to grant, reciprocal marketing approval with respect to a covered product not later than 30 days after the Secretary’s receipt of a request under subsection (b)(1) for the product.
(3) Effect of Congressional disapproval Reciprocal marketing approval under this section with respect to the applicable covered product shall take effect upon enactment of a joint resolution of disapproval under this subsection.
Section 1 would name the bill the Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025.
1. Short title This Act may be cited as the Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025.
Section 2 would add a reciprocal marketing approval pathway to the Federal Food, Drug, and Cosmetic Act. A product approved through this pathway would be treated as having the applicable existing U.S. approval or clearance—the regulatory permission needed to market the product.
The Federal Food, Drug, and Cosmetic Act is amended by inserting after section 524B of such Act (21 U.S.C. 360n–2) the following:
(a) In general A covered product with reciprocal marketing approval in effect under this section is deemed to be subject to an application or premarket notification for which an approval or clearance is in effect under section 505(c), 510(k), or 515 of this Act or section 351(a) of the Public Health Service Act, as applicable.
Subject to the separate safety and effectiveness provision, the Secretary would have to grant approval when a sponsor requests it and demonstrates all eligibility criteria to the Secretary’s satisfaction. The product would need authorization in at least one country on an existing statutory list or in the United Kingdom, lack the applicable U.S. approval or clearance, and address a U.S. public health or unmet medical need.
(b) Eligibility The Secretary shall, with respect to a covered product, grant reciprocal marketing approval if— (1) the sponsor of the covered product submits a request for reciprocal marketing approval; and (2) the request demonstrates to the Secretary’s satisfaction that— (A) the covered product is authorized to be lawfully marketed in one or more of the countries included in the list under section 802(b)(1) or in the United Kingdom; (B) absent reciprocal marketing approval, the covered product is not approved or cleared for marketing, as described in subsection (a);
(F) there is a public health or unmet medical need for the covered product in the United States.
(A) may decline to grant reciprocal marketing approval under this section with respect to a covered product if the Secretary affirmatively determines that the covered product— (i) is a drug that is not safe and effective; or (ii) is a device for which there is no reasonable assurance of safety and effectiveness;
Eligibility would also require that the Secretary had not rescinded or withdrawn the relevant U.S. approval or clearance because of safety or effectiveness concerns, that the specified foreign marketing authorization had not been rescinded or withdrawn for those reasons, and that the product was not a banned device.
(C) the Secretary has not, because of any concern relating to the safety or effectiveness of the covered product, rescinded or withdrawn any such approval or clearance; (D) the authorization to market the covered product in one or more of the countries included in the list under section 802(b)(1) or in the United Kingdom has not, because of any concern relating to the safety or effectiveness of the covered product, been rescinded or withdrawn; (E) the covered product is not a banned device under section 516;
The Secretary could deny approval after affirmatively determining that a drug is not safe and effective, or that a device lacks reasonable assurance of safety and effectiveness. Approval could also depend on specified studies after the product reaches the market, including studies under a statutory strategy for evaluating and reducing risks.
(c) Safety and effectiveness (1) In general The Secretary— (A) may decline to grant reciprocal marketing approval under this section with respect to a covered product if the Secretary affirmatively determines that the covered product— (i) is a drug that is not safe and effective; or (ii) is a device for which there is no reasonable assurance of safety and effectiveness; and (B) may condition reciprocal marketing approval under this section on the conduct of specified postmarket studies, which may include such studies pursuant to a risk evaluation and mitigation strategy under section 505–1.
The Secretary would have to list denials each month and submit that list by the end of the month to the House Energy and Commerce Committee and the Senate Health, Education, Labor, and Pensions Committee.
(2) Report to Congress Upon declining to grant reciprocal marketing approval under this section with respect to a covered product, the Secretary shall— (A) include the denial in a list of such denials for each month; and (B) not later than the end of the respective month, submit the list to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate.
The Secretary would set the request’s format, submission method, and information requirements for determining eligibility. For each country on the referenced statutory list where the product is authorized, the request would have to include an English translation of that country’s authorization dossier—the documents issued to authorize marketing.
(d) Request A request for reciprocal marketing approval shall— (1) be in such form, be submitted in such manner, and contain such information as the Secretary deems necessary to determine whether the criteria listed in subsection (b)(2) are met; and (2) include, with respect to each country included in the list under section 802(b)(1) where the covered product is authorized to be lawfully marketed, as described in subsection (b)(2)(A), an English translation of the dossier issued by such country to authorize such marketing.
The Secretary would have to issue an approval or denial order within 30 days after receiving a request. The order would take effect subject to the bill’s congressional disapproval process.
(e) Timing The Secretary shall issue an order granting, or declining to grant, reciprocal marketing approval with respect to a covered product not later than 30 days after the Secretary’s receipt of a request under subsection (b)(1) for the product. An order issued under this subsection shall take effect subject to Congressional disapproval under subsection (g).
Within that same 30-day period, the Secretary and sponsor would have to negotiate and finalize the labeling for a product that is to receive approval.
(f) Labeling; device classification During the 30-day period described in subsection (e)— (1) the Secretary and the sponsor of the covered product shall expeditiously negotiate and finalize the form and content of the labeling for a covered product for which reciprocal marketing approval is to be granted;
For a device that is to receive approval, the Secretary would also have to assign its regulatory classification within the 30-day period and determine which of two existing clearance or approval routes would otherwise apply.
(f) Labeling; device classification During the 30-day period described in subsection (e)—
(2) in the case of a device for which reciprocal marketing approval is to be granted, the Secretary shall— (A) classify the device pursuant to section 513; and (B) determine whether, absent reciprocal marketing approval, the device would need to be cleared pursuant to section 510(k) or approved pursuant to section 515 to be lawfully marketed under this Act.
An enacted joint resolution—a legislative measure that must become law—could block a denial. Reciprocal marketing approval for the product would then take effect upon enactment of that resolution.
(g) Congressional disapproval of FDA orders (1) In general A decision of the Secretary to decline to grant reciprocal marketing approval under this section shall not take effect if a joint resolution of disapproval of the decision is enacted.
(3) Effect of Congressional disapproval Reciprocal marketing approval under this section with respect to the applicable covered product shall take effect upon enactment of a joint resolution of disapproval under this subsection.
Congress would consider a disapproval resolution under procedures incorporated from title 5 of the U.S. Code. Two references in those procedures would be redirected to the bill’s monthly denial-report requirement; the underlying procedures are not reproduced in the source.
(2) Procedure (A) In general Subject to subparagraph (B), the procedures described in subsections (b) through (g) of section 802 of title 5, United States Code, shall apply to the consideration of a joint resolution under this subsection. (B) Terms For purposes of this subsection— (i) the reference to section 801(a)(1) in section 802(b)(2)(A) of title 5, United States Code, shall be considered to refer to subsection (c)(2); and (ii) the reference to section 801(a)(1)(A) in section 802(e)(2) of title 5, United States Code, shall be considered to refer to subsection (c)(2).
The Federal Food, Drug, and Cosmetic Act would apply to products approved through this pathway to the same extent and in the same manner as products with the applicable existing approval or clearance.
(h) Applicability of relevant provisions The provisions of this Act shall apply with respect to a covered product for which reciprocal marketing approval is in effect to the same extent and in the same manner as such provisions apply with respect to a product for which approval or clearance of an application or premarket notification under section 505(c), 510(k), or 515 of this Act or section 351(a) of the Public Health Service Act, as applicable, is in effect.
For fees under chapter VII, a reciprocal approval request would be treated as the applicable existing application or premarket notification. The bill does not specify fee amounts.
(i) Fees for request For purposes of imposing fees under chapter VII, a request for reciprocal marketing approval under this section shall be treated as an application or premarket notification for approval or clearance under section 505(c), 510(k), or 515 of this Act or section 351(a) of the Public Health Service Act, as applicable.
The Secretary would have to conduct an outreach campaign encouraging sponsors of potentially eligible products to request reciprocal approval.
(j) Outreach The Secretary shall conduct an outreach campaign to encourage the sponsors of covered products that are potentially eligible for reciprocal marketing approval to request such approval.
The supplied action snapshot, updated January 21, 2026, records introduction in the House on February 26, 2025, and referral that day to the Energy and Commerce Committee and additionally to the Rules Committee for provisions within their respective jurisdictions.
Source snapshot updated 2026-01-21T05:03:49Z.
2025-02-26: Introduced in House
2025-02-26: 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.
A closer look
Reviewed version: Introduced in House · 2025-02-26. These findings describe provisions and who may benefit; they are not judgments of waste, corruption, or motive.
This review covers the supplied bill text. “None identified” does not rule out provisions in later versions or accompanying reports and disclosures.
Provisions outside the bill’s main subject, or policy changes attached to appropriations.
None identified in the reviewed text
No unrelated provision or policy attached to appropriations was identified in the complete supplied introduced text. This conclusion is limited to that version and does not establish what appears in other versions or accompanying materials.
Spending directed to particular recipients or places outside ordinary competitive or formula-based allocation.
None identified in the reviewed text
No congressionally directed spending for particular recipients or places was identified in the complete supplied introduced text. This conclusion is limited to that version; earmark disclosures and accompanying committee or conference materials were not supplied.
Narrow exceptions, exemptions, or preferential treatment that warrant a closer look.
None identified in the reviewed text
No materially narrow carve-out, special exemption, or preferential exception beyond the pathway’s ordinary eligibility rules was identified in the complete supplied introduced text. This conclusion is limited to that version and does not establish absence in other versions or accompanying materials.
Full text preserved for this analysis. Legislative record snapshot: Jan 21, 2026. How PlainBill uses AI