H.R. 7953

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7953 Introduced in House (IH)]

<DOC>

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.''.
<all>