119-s3081

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 3081 Introduced in Senate

    (IS) ]

<DOC>

119th CONGRESS
 1st Session
 S. 3081

 To amend the Federal Food, Drug, and Cosmetic Act to provide for 
 reciprocal marketing approval of certain drugs, biological products, 
and devices that are authorized to be lawfully marketed abroad, and for 
 other purposes.

_______________________________________________________________________

 IN THE SENATE OF THE UNITED STATES

 October 30, 2025

Mr. Cruz (for himself and Mr. Lee) introduced the following bill; which 
 was read twice and referred to the Committee on Health, Education, 
 Labor, and Pensions

_______________________________________________________________________

 A BILL

 To amend the Federal Food, Drug, and Cosmetic Act to provide for 
 reciprocal marketing approval of certain drugs, biological products, 
and devices that are authorized to be lawfully marketed abroad, and for 
 other purposes.

 Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

 This Act may be cited as the ``Reciprocity Ensures Streamlined Use 
of Lifesaving Treatments Act of 2025''.

SEC. 2. RECIPROCAL MARKETING APPROVAL FOR CERTAIN DRUGS, BIOLOGICAL 
 PRODUCTS, AND DEVICES.

 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:

``

SEC. 524C. RECIPROCAL MARKETING APPROVAL.

 ``

    (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.
 ``

    (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) ;
 ``
            (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; and
 ``
        (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.
 ``

    (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.
 ``
            (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.
 ``

    (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) .
 ``

    (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; and
 ``

    (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.
 ``

    (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.
 ``

    (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) .
 ``

    (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.
 ``

    (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.
 ``
            (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.
 ``

    (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.
 ``

    (k) Covered Product Defined.--In this section, the term `covered 
product' means a drug, biological product, or device.''.
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