[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7472 Introduced in House (IH)]
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117th CONGRESS
2d Session
H. R. 7472
To amend the Federal Food, Drug, and Cosmetic Act to grant eligible
researchers access to eligible products at a discounted price for
qualified research, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
April 7, 2022
Mrs. Carolyn B. Maloney of New York (for herself, Mr. Welch, Ms.
Schakowsky, Ms. Porter, Mr. DeSaulnier, and Mr. Raskin) introduced the
following bill; which was referred to the Committee on Energy and
Commerce
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to grant eligible
researchers access to eligible products at a discounted price for
qualified research, 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 ``Discounted Drugs for Clinical Trials
Act''.
SEC. 2. DISCOUNTED SALES OF ELIGIBLE PRODUCTS FOR QUALIFIED RESEARCH
PURPOSES.
(a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 505-2
of such Act (21 U.S.C. 355-1) the following new section:
``SEC. 505-3. DISCOUNTED SALES OF ELIGIBLE PRODUCTS FOR QUALIFIED
RESEARCH PURPOSES.
``(a) Application by Researcher.--To obtain an eligible product for
qualified research at the discounted price, an individual or entity
shall submit to the Secretary an application certifying and
demonstrating that--
``(1) the individual or entity is an eligible researcher;
``(2) the product being sought is an eligible product;
``(3) the researcher seeks to use the eligible product for
qualified research; and
``(4) the amount of the eligible product sought is
reasonable for completing the qualified research.
``(b) Duties of Secretary.--The Secretary shall--
``(1) review each application submitted under paragraph (1)
in a timely manner;
``(2) provide to the applicant, within a reasonable time of
such submission--
``(A) a written order specifying the sufficient
quantity of the eligible product approved to be
purchased by the eligible researcher at the discounted
price; or
``(B) a written denial of the application;
``(3) require manufacturers and license holders to report
to the Secretary any additional information determined by the
Secretary to be necessary to carry out this section; and
``(4) annually publish information on the number and types
of applications granted and denied under this section.
``(c) Acquisition of Discounted Drug.--Upon receipt from an
eligible researcher of an order obtained under subsection (b)(2)(A) for
the acquisition of an eligible product for qualified research, the
manufacturer or license holder of the eligible product shall sell to
the eligible researcher the quantity specified in the order at the
discounted price.
``(d) Civil Action for Failure To Provide Sufficient Quantity of an
Eligible Product.--
``(1) In general.--An eligible researcher may bring a civil
action against the manufacturer or license holder of an
eligible product seeking relief under this subsection in an
appropriate district court of the United States alleging that
the manufacturer or license holder has declined to provide the
quantity of the eligible product specified in a written order
from the Secretary to the eligible researcher for the
discounted price.
``(2) Elements.--To prevail in a civil action brought under
paragraph (1), an eligible researcher shall prove, by a
preponderance of the evidence, that--
``(A) the eligible researcher has--
``(i) obtained a written order for the
specified quantity of the eligible product from
the Secretary in accordance with subsection
(b)(2)(A); and
``(ii) provided a copy of the order to the
manufacturer or license holder; and
``(B) as of the date on which the civil action is
filed, the eligible researcher has not obtained the
specified quantity of the eligible product at the
discounted price by 31 days after the date on which the
manufacturer or license holder received the eligible
researcher's request for the eligible product,
including a copy of the written order.
``(3) Affirmative defense.--In a civil action brought under
paragraph (1), it shall be an affirmative defense, on which the
defendant has the burden of persuasion by a preponderance of
the evidence--
``(A) that, on the date on which the eligible
researcher requested to purchase the specified quantity
of the eligible product from the manufacturer or
license holder--
``(i) neither the manufacturer, license
holder, nor any of their agents, wholesalers,
or distributors, was engaged in the
manufacturing or commercial marketing of the
eligible product; and
``(ii) neither the manufacturer, license
holder, nor any of their agents, wholesalers,
or distributors, otherwise had access to
inventory of the eligible product to supply the
specified quantity to the eligible researcher
at the discounted price;
``(B) that--
``(i) the manufacturer or license holder
sells the eligible product through agents,
distributors, or wholesalers;
``(ii) the manufacturer has placed no
restrictions, explicit or implicit, on its
agents, distributors, or wholesalers on selling
the eligible product to eligible researchers;
and
``(iii) the eligible product can be
purchased by the eligible researcher in the
specified quantity at the discounted price or a
lower price from the agents, distributors, or
wholesalers of the manufacturer or license
holder; or
``(C) that the manufacturer or license holder made
an offer to sell the specified quantity of the eligible
product to the eligible researcher for the discounted
price and the eligible researcher did not accept such
offer by the date that is 14 days after the date on
which the eligible product researcher received such
offer.
``(4) Methods for transmission of requests for eligible
products.--A written request for an eligible product, offer to
sell an eligible product, or acceptance of such an offer
between the eligible researcher and the manufacturer or license
holder of the eligible product shall be made by--
``(A) certified or registered mail with return
receipt requested;
``(B) personal delivery; or
``(C) electronic means.
``(5) Remedies.--If an eligible researcher prevails in a
civil action brought under paragraph (1), the court shall--
``(A) order the manufacturer or license holder to
provide to the eligible researcher without delay the
specified quantity of the eligible product at the
discounted price;
``(B) award to the eligible researcher reasonable
attorney's fees and costs of the civil action; and
``(C) award to the eligible researcher a monetary
amount sufficient to deter the manufacturer or license
holder from failing to provide eligible researchers
with a sufficient quantity of an eligible product at
the discounted price, if the court finds, by a
preponderance of the evidence, that the manufacturer or
license holder, without a legitimate business
justification--
``(i) delayed providing the specified
quantity to the eligible researcher; or
``(ii) failed to comply with a written
order under subsection (b)(2)(A).
``(6) Maximum monetary amount.--A monetary amount awarded
under paragraph (5) shall not be greater than the revenue that
the manufacturer or license holder earned on the eligible
product beginning on the date that is 31 days after the date on
which the manufacturer or license holder received the request
and ending on the date on which the eligible researcher
received the specified quantity of the eligible product.
``(7) Avoidance of delay.--The court may issue an order
under paragraph (5)(A) before conducting further proceedings
that may be necessary to determine--
``(A) whether the eligible researcher is entitled
to an award under subparagraph (B) or (C) of paragraph
(5); or
``(B) the amount of any such award.
``(e) Limitation of Liability.--A manufacturer or license holder of
an eligible product obtained by an eligible researcher pursuant to this
section shall not be liable for any claim under Federal, State, or
local law arising out of the failure of the eligible researcher to
follow adequate safeguards to assure safe use of the eligible product,
including with respect to transportation, handling, use, or disposal.
``(f) Rule of Construction.--This section shall not be construed
to--
``(1) undermine or abrogate any requirement imposed
pursuant to a risk evaluation and mitigation strategy under
section 505-1; or
``(2) interfere with the private right of action afforded
under section 610 of division N of the Further Consolidated
Appropriations Act, 2020 (Public Law 116-94) (21 U.S.C. 355-2
note; commonly referred to as the `CREATES Act').
``(g) Definitions.--In this section:
``(1) Commissioner.--The term `Commissioner' means the
Commissioner of Food and Drugs.
``(2) Combination product.--The term `combination product'
means a combination product described in section 503(g).
``(3) Discounted price.--The term `discounted price' means
the direct costs to the manufacturer or license holder of
producing the eligible product.
``(4) Eligible product.--The term `eligible product'
means--
``(A) any--
``(i) drug approved under section 505(c) of
this Act or biological product licensed under
section 351(a) of the Public Health Service
Act;
``(ii) combination product including such a
drug or biological product; or
``(iii) product, including any device, that
is marketed or intended for use with such a
drug or biological product; and
``(B) any product that is--
``(i) a covered part D drug (as defined in
section 1860D-2(e) of the Social Security Act)
eligible for placement on, with respect to a
plan year, a specialty tier (as defined in
section 423.560 of title 42, Code of Federal
Regulations) of a formulary for such plan year
of a prescription drug plan under part D of
title XVIII of such Act or an MA-PD plan under
part C of such title; or
``(ii) a drug (including any biological
product), or combination product, whose cost is
determined by the Commissioner to be
prohibitive to the advancement of qualified
research.
``(5) Eligible researcher.--The term `eligible researcher'
means any individual or entity seeking to obtain an eligible
product for qualified research.
``(6) License holder.--The term `license holder' means the
holder of an application approved under section subsection (c)
or (j) of section 505 of this Act, or a license under
subsection (a) or (k) of section 351 of the Public Health
Service Act, for an eligible product.
``(7) Qualified research.--The term `qualified research'
means--
``(A) research in furtherance of an application
under section 505(b) or (j) of this Act;
``(B) research in furtherance of an application for
a license under section 351(a) or (k) of the Public
Health Service Act;
``(C) research for which an exemption for
investigational use is granted pursuant to section
505(i) of this Act or section 351(a) of the Public
Health Service Act; or
``(D) research using an approved drug for an
approved indication with the purpose of evaluating and
comparing the clinical effectiveness, risks, or
benefits of 2 or more of any of the following:
``(i) Health care interventions, protocols
for treatment, care management, delivery
procedures, diagnostic tools, or integrative
practices.
``(ii) Drugs (including biological
products), devices, or combination products.
``(iii) Any other treatments, services,
practices, or items being used in the
treatment, management, or diagnosis of, or
prevention of, illness or injury in
individuals.
``(8) Sufficient quantity.--The term `sufficient quantity'
means an amount of an eligible product no greater than the
eligible researcher determines to be necessary to accomplish
the qualified research and fulfill any related regulatory
requirements.''.
(b) Regulations.--Not later than 180 days of the date of enactment
of this Act, the Secretary of Health and Human Services shall
promulgate final regulations to carry out section 505-3 of the Federal
Food, Drug, and Cosmetic Act, as added by subsection (a), including
regulations to appropriately calculate the discounted price applicable
with respect to an eligible product (as such terms are defined in such
section 505-3).
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