[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7953 Introduced in House (IH)]
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119th CONGRESS
2d Session
H. R. 7953
To accelerate patient access to innovative medicines and clinical
trials for life-threatening diseases by establishing a reciprocal
approval mechanism with trusted international regulatory authorities.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
March 17, 2026
Mr. Sessions (for himself and Mr. Peters) introduced the following
bill; which was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To accelerate patient access to innovative medicines and clinical
trials for life-threatening diseases by establishing a reciprocal
approval mechanism with trusted international regulatory authorities.
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 ``Fast-tracking Approval for
Innovative Rare disease therapies Act'' or the ``FAIR ACT''.
SEC. 2. FINDINGS.
Congress finds the following:
(1) Patients in the United States often face significant
delays in accessing innovative medicines compared to patients
in other trusted nations.
(2) The lengthy regulatory process at the Food and Drug
Administration contributes to the movement of clinical trials
abroad, leading to fewer opportunities for United States
patients to participate in cutting-edge research.
(3) China and other nations are rapidly expanding their
clinical trial and biopharmaceutical development capacity,
threatening United States leadership in biomedical innovation.
(4) A reciprocal approval mechanism with trusted
international regulatory authorities will accelerate access for
United States patients to life-saving therapies and preserve
the United States competitive position in biomedical research
and innovation.
SEC. 3. RECIPROCAL MARKETING APPROVAL FOR CERTAIN DRUGS.
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 FOR CERTAIN DRUGS.
``(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 is in
effect under section 505(c) or 510(k) 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 lawfully marketed in a
foreign country pursuant to an authorization from a
trusted international regulatory authority of that
country;
``(B) absent reciprocal marketing approval, the
covered product is not approved 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;
``(D) the authorization to market the covered
product in a foreign country pursuant to an
authorization from a trusted international regulatory
authority of that country has not, because of any
concern relating to the safety or effectiveness of the
covered product, been rescinded or withdrawn; and
``(E) the covered product is intended for use in
the diagnosis, treatment, or mitigation of an
immediately life-threatening disease or condition.
``(c) 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 determines necessary
to determine whether the criteria listed in subsection (b)(2)
are met; and
``(2) include, with respect to each trusted international
regulatory authority that authorized a covered product to be
lawfully marketed in the foreign country involved, as described
in subsection (b)(2)(A), an English translation (if necessary)
of the dossier issued by such regulatory authority to authorize
such marketing.
``(d) 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.
``(e) Labeling; Post-Market Requirements.--During the 30-day period
described in subsection (d), the Secretary shall finalize--
``(1) the form and content of the labeling for a covered
product for which reciprocal marketing approval is to be
granted; and
``(2) any postmarket studies the Secretary determines
necessary to ensure the safety and effectiveness of such
product.
``(f) 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 of an application or premarket notification under section
505(c) or 510(k) of this Act or section 351(a) of the Public Health
Service Act, as applicable, is in effect.
``(g) Withdrawal of Reciprocal Marketing Approval.--
``(1) In general.--The Secretary may, at any time, withdraw
or suspend reciprocal marketing approval with respect to a
covered product granted under this section if--
``(A) new clinical or real-world evidence
demonstrates that the product presents an unreasonable
risk of serious adverse events or mortality; or
``(B) the trusted international regulatory
authority that originally authorized the covered
product has rescinded or suspended its approval in the
applicable foreign country.
``(2) Effect of withdrawal or suspension.--If the
withdrawal or suspension under paragraph (1) is based on
adverse event reports occurring within the first 30 days after
reciprocal marketing approval, the Secretary shall provide
public notice and may require immediate cessation of marketing
and distribution.
``(3) Phase-out option.--The Secretary may implement a
phase-out plan for withdrawal under paragraph (1), including
patient transition measures, to protect public health while
minimizing disruption to ongoing treatment.
``(h) 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 under section 505(c) or 510(k) or section 351(a) of the
Public Health Service Act, as applicable.
``(i) Report.--Not later than 5 years after the date of enactment
of this section, the Secretary shall submit to the Committee on Energy
and Commerce and the Committee on Ways and Means of the House of
Representatives and the Committee on Finance and the Committee on
Health, Education, Labor, and Pensions of the Senate a comprehensive
report on--
``(1) the effectiveness of the reciprocal marketing
approval program under this section in accelerating access to
innovative medicines in the United States;
``(2) the number of reciprocal marketing approvals of
covered products granted or denied under this section;
``(3) the impact of the reciprocal marketing approval
program under this section on patient safety and adverse event
reporting; and
``(4) recommendations for the continuation, modification,
or termination of the reciprocal marketing approval program
under this section.
``(j) Definitions.--In this section:
``(1) Covered product.--The term `covered product' means a
drug, including a biological product (as defined in section
351(i) of the Public Health Service Act (42 U.S.C. 262(i))).
``(2) Immediately life-threatening disease or condition.--
The term `immediately life-threatening disease or condition'
has the meaning given such term in section 312.300(b)(1) of
title 21, Code of Federal Regulations (or successor
regulations).
``(3) Trusted international regulatory authority.--The term
`trusted international regulatory authority' means--
``(A) the European Medicines Agency;
``(B) the Medicines and Healthcare Products
Regulatory Agency of the United Kingdom;
``(C) Health Canada; and
``(D) any other international regulatory authority
designated by the Secretary of Health and Human
Services.''.
SEC. 4. RECIPROCAL ALLOWANCE OF CLINICAL INVESTIGATIONS AUTHORIZED BY
TRUSTED INTERNATIONAL REGULATORY AUTHORITIES.
Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
351 et seq.) is amended by inserting after section 569B (21 U.S.C.
360bbb-8b) the following:
``SEC. 569B-1. RECIPROCAL ALLOWANCE OF CLINICAL INVESTIGATIONS
AUTHORIZED BY TRUSTED INTERNATIONAL REGULATORY
AUTHORITIES.
``(a) In General.--A manufacturer may seek reciprocal allowance to
conduct a clinical trial under section 505(i) of this Act or section
351(a)(3) of the Public Health Service Act with respect to a qualified
product by submitting an application for such allowance to the
Secretary.
``(b) Application.--A manufacturer seeking reciprocal allowance
under subsection (a) to conduct a clinical investigation as described
in subsection (a) shall submit to the Secretary an application
containing--
``(1) the authorization by a trusted international
regulatory authority to conduct the same clinical investigation
with respect to a qualified product in the applicable foreign
country; and
``(2) any supporting documentation for such authorization.
``(c) Treatment.--The Secretary shall, for purposes of applying
section 505(i) of this Act or section 351(a)(3) of the Public Health
Service Act--
``(1) treat an application for reciprocal allowance with
respect to a qualified product under this section as meeting
the criteria applicable to a submission under section 505(i)(2)
of this Act (or pursuant to section 351(a)(3) of the Public
Health Service Act) with respect to beginning a clinical
investigation of a new drug (or biological product); and
``(2) pursuant to that treatment, issue an order allowing,
or declining to allow, a reciprocal allowance with respect to
such qualified product not later than 30 days after the
Secretary's receipt of a request under subsection (b) for the
product.
``(d) Applicability of Provisions.--The provisions of section
505(i) of this Act and section 351(a)(3) shall apply with respect to an
application for reciprocal allowance under this section to the same
extent and in the same manner as such provisions apply to an
investigational new drug application under section 505(i) of this Act
or section 351(a)(3) of the Public Health Service Act.
``(e) Protocol Modifications.--The Secretary may request, before
the end of the 30-day period specified in subsection (c)(2), that the
manufacturer requesting a reciprocal allowance with respect to a
clinical investigation under this section modify the protocols for such
clinical investigation. The Secretary shall, notwithstanding a request
for modification of protocols under this subsection, grant, or decline
to grant such reciprocal allowance within such 30-day period.
``(f) Qualified Product Defined.--In this section, the term
`qualified product' means a covered product (as defined in section
524B) that is intended for use in the diagnosis, treatment, or
mitigation of an immediately life-threatening disease or condition.''.
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