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[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.''.
<all>
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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