[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 4053 Introduced in Senate (IS)]

<DOC>






117th CONGRESS
  2d Session
                                S. 4053

  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 SENATE OF THE UNITED STATES

                             April 7, 2022

Ms. Stabenow (for herself and Ms. Smith) 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 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 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).
                                 <all>