II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Discounted Drugs for 

5 Clinical Trials Act’’. 


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1 SEC. 2. DISCOUNTED SALES OF ELIGIBLE PRODUCTS FOR 

2 QUALIFIED RESEARCH PURPOSES. 

3 (a) IN GENERAL.—Chapter V of the Federal Food, 

4 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend5 ed by inserting after section 505–2 of such Act (21 U.S.C. 

6 355–1) the following new section: 

7 ‘‘SEC. 505–3. DISCOUNTED SALES OF ELIGIBLE PRODUCTS 

8 FOR QUALIFIED RESEARCH PURPOSES. 

9 ‘‘(a) APPLICATION BY RESEARCHER.—To obtain an 

10 eligible product for qualified research at the discounted 

11 price, an individual or entity shall submit to the Secretary 

12 an application certifying and demonstrating that— 

13 ‘‘(1) the individual or entity is an eligible re14 searcher; 

15 ‘‘(2) the product being sought is an eligible 

16 product; 

17 ‘‘(3) the researcher seeks to use the eligible 

18 product for qualified research; and 

19 ‘‘(4) the amount of the eligible product sought 

20 is reasonable for completing the qualified research. 

21 ‘‘(b) DUTIES OF SECRETARY.—The Secretary shall— 

22 ‘‘(1) review each application submitted under 

23 paragraph (1) in a timely manner; 

24 ‘‘(2) provide to the applicant, within a reason25 able time of such submission— 


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1 ‘‘(A) a written order specifying the suffi2 cient quantity of the eligible product approved 

3 to be purchased by the eligible researcher at the 

4 discounted price; or 

5 ‘‘(B) a written denial of the application; 

6 ‘‘(3) require manufacturers and license holders 

7 to report to the Secretary any additional information 

8 determined by the Secretary to be necessary to carry 

9 out this section; and 

10 ‘‘(4) annually publish information on the num11 ber and types of applications granted and denied 

12 under this section. 

13 ‘‘(c) ACQUISITION OF DISCOUNTED DRUG.—Upon 

14 receipt from an eligible researcher of an order obtained 

15 under subsection (b)(2)(A) for the acquisition of an eligi16 ble product for qualified research, the manufacturer or li17 cense holder of the eligible product shall sell to the eligible 

18 researcher the quantity specified in the order at the dis19 counted price. 

20 ‘‘(d) CIVIL ACTION FOR FAILURE TO PROVIDE SUF21 FICIENT QUANTITY OF AN ELIGIBLE PRODUCT.— 

22 ‘‘(1) IN GENERAL.—An eligible researcher may 

23 bring a civil action against the manufacturer or li24 cense holder of an eligible product seeking relief 

25 under this subsection in an appropriate district 


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1 court of the United States alleging that the manu2 facturer or license holder has declined to provide the 

3 quantity of the eligible product specified in a written 

4 order from the Secretary to the eligible researcher 

5 for the discounted price. 

6 ‘‘(2) ELEMENTS.—To prevail in a civil action 

7 brought under paragraph (1), an eligible researcher 

8 shall prove, by a preponderance of the evidence, 

9 that— 

10 ‘‘(A) the eligible researcher has— 

11 ‘‘(i) obtained a written order for the 

12 specified quantity of the eligible product 

13 from the Secretary in accordance with sub14 section (b)(2)(A); and 

15 ‘‘(ii) provided a copy of the order to 

16 the manufacturer or license holder; and 

17 ‘‘(B) as of the date on which the civil ac18 tion is filed, the eligible researcher has not ob19 tained the specified quantity of the eligible 

20 product at the discounted price by 31 days 

21 after the date on which the manufacturer or li22 cense holder received the eligible researcher’s 

23 request for the eligible product, including a 

24 copy of the written order. 


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1 ‘‘(3) AFFIRMATIVE DEFENSE.—In a civil action 

2 brought under paragraph (1), it shall be an affirma3 tive defense, on which the defendant has the burden 

4 of persuasion by a preponderance of the evidence— 

5 ‘‘(A) that, on the date on which the eligible 

6 researcher requested to purchase the specified 

7 quantity of the eligible product from the manu8 facturer or license holder— 

9 ‘‘(i) neither the manufacturer, license 

10 holder, nor any of their agents, whole11 salers, or distributors, was engaged in the 

12 manufacturing or commercial marketing of 

13 the eligible product; and 

14 ‘‘(ii) neither the manufacturer, license 

15 holder, nor any of their agents, whole16 salers, or distributors, otherwise had access 

17 to inventory of the eligible product to sup18 ply the specified quantity to the eligible re19 searcher at the discounted price; 

20 ‘‘(B) that— 

21 ‘‘(i) the manufacturer or license hold22 er sells the eligible product through agents, 

23 distributors, or wholesalers; 

24 ‘‘(ii) the manufacturer has placed no 

25 restrictions, explicit or implicit, on its 


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1 agents, distributors, or wholesalers on sell2 ing the eligible product to eligible research3 ers; and 

4 ‘‘(iii) the eligible product can be pur5 chased by the eligible researcher in the 

6 specified quantity at the discounted price 

7 or a lower price from the agents, distribu8 tors, or wholesalers of the manufacturer or 

9 license holder; or 

10 ‘‘(C) that the manufacturer or license hold11 er made an offer to sell the specified quantity 

12 of the eligible product to the eligible researcher 

13 for the discounted price and the eligible re14 searcher did not accept such offer by the date 

15 that is 14 days after the date on which the eli16 gible product researcher received such offer. 

17 ‘‘(4) METHODS FOR TRANSMISSION OF RE18 QUESTS FOR ELIGIBLE PRODUCTS.—A written re19 quest for an eligible product, offer to sell an eligible 

20 product, or acceptance of such an offer between the 

21 eligible researcher and the manufacturer or license 

22 holder of the eligible product shall be made by— 

23 ‘‘(A) certified or registered mail with re24 turn receipt requested; 

25 ‘‘(B) personal delivery; or 


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1 ‘‘(C) electronic means. 

2 ‘‘(5) REMEDIES.—If an eligible researcher pre3 vails in a civil action brought under paragraph (1), 

4 the court shall— 

5 ‘‘(A) order the manufacturer or license 

6 holder to provide to the eligible researcher with7 out delay the specified quantity of the eligible 

8 product at the discounted price; 

9 ‘‘(B) award to the eligible researcher rea10 sonable attorney’s fees and costs of the civil ac11 tion; and 

12 ‘‘(C) award to the eligible researcher a 

13 monetary amount sufficient to deter the manu14 facturer or license holder from failing to provide 

15 eligible researchers with a sufficient quantity of 

16 an eligible product at the discounted price, if 

17 the court finds, by a preponderance of the evi18 dence, that the manufacturer or license holder, 

19 without a legitimate business justification— 

20 ‘‘(i) delayed providing the specified 

21 quantity to the eligible researcher; or 

22 ‘‘(ii) failed to comply with a written 

23 order under subsection (b)(2)(A). 

24 ‘‘(6) MAXIMUM MONETARY AMOUNT.—A mone25 tary amount awarded under paragraph (5) shall not 


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1 be greater than the revenue that the manufacturer 

2 or license holder earned on the eligible product be3 ginning on the date that is 31 days after the date 

4 on which the manufacturer or license holder received 

5 the request and ending on the date on which the eli6 gible researcher received the specified quantity of 

7 the eligible product. 

8 ‘‘(7) AVOIDANCE OF DELAY.—The court may 

9 issue an order under paragraph (5)(A) before con10 ducting further proceedings that may be necessary 

11 to determine— 

12 ‘‘(A) whether the eligible researcher is en13 titled to an award under subparagraph (B) or 

14 (C) of paragraph (5); or 

15 ‘‘(B) the amount of any such award. 

16 ‘‘(e) LIMITATION OF LIABILITY.—A manufacturer or 

17 license holder of an eligible product obtained by an eligible 

18 researcher pursuant to this section shall not be liable for 

19 any claim under Federal, State, or local law arising out 

20 of the failure of the eligible researcher to follow adequate 

21 safeguards to assure safe use of the eligible product, in22 cluding with respect to transportation, handling, use, or 

23 disposal. 

24 ‘‘(f) RULE OF CONSTRUCTION.—This section shall 

25 not be construed to— 


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1 ‘‘(1) undermine or abrogate any requirement 

2 imposed pursuant to a risk evaluation and mitiga3 tion strategy under section 505–1; or 

4 ‘‘(2) interfere with the private right of action 

5 afforded under section 610 of division N of the Fur6 ther Consolidated Appropriations Act, 2020 (Public 

7 Law 116–94) (21 U.S.C. 355–2 note; commonly re8 ferred to as the ‘CREATES Act’). 

9 ‘‘(g) DEFINITIONS.—In this section: 

10 ‘‘(1) COMMISSIONER.—The term ‘Commis11 sioner’ means the Commissioner of Food and Drugs. 

12 ‘‘(2) COMBINATION PRODUCT.—The term ‘com13 bination product’ means a combination product de14 scribed in section 503(g). 

15 ‘‘(3) DISCOUNTED PRICE.—The term ‘dis16 counted price’ means the direct costs to the manu17 facturer or license holder of producing the eligible 

18 product. 

19 ‘‘(4) ELIGIBLE PRODUCT.—The term ‘eligible 

20 product’ means— 

21 ‘‘(A) any— 

22 ‘‘(i) drug approved under section 

23 505(c) of this Act or biological product li24 censed under section 351(a) of the Public 

25 Health Service Act; 


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1 ‘‘(ii) combination product including 

2 such a drug or biological product; or 

3 ‘‘(iii) product, including any device, 

4 that is marketed or intended for use with 

5 such a drug or biological product; and 

6 ‘‘(B) any product that is— 

7 ‘‘(i) a covered part D drug (as defined 

8 in section 1860D–2(e) of the Social Secu9 rity Act) eligible for placement on, with re10 spect to a plan year, a specialty tier (as de11 fined in section 423.560 of title 42, Code 

12 of Federal Regulations) of a formulary for 

13 such plan year of a prescription drug plan 

14 under part D of title XVIII of such Act or 

15 an MA–PD plan under part C of such 

16 title; or 

17 ‘‘(ii) a drug (including any biological 

18 product), or combination product, whose 

19 cost is determined by the Commissioner to 

20 be prohibitive to the advancement of quali21 fied research. 

22 ‘‘(5) ELIGIBLE RESEARCHER.—The term ‘eligi23 ble researcher’ means any individual seeking to ob24 tain an eligible product for qualified research. 


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1 ‘‘(6) LICENSE HOLDER.—The term ‘license 

2 holder’ means the holder of an application approved 

3 under section subsection (c) or (j) of section 505 of 

4 this Act, or a license under subsection (a) or (k) of 

5 section 351 of the Public Health Service Act, for an 

6 eligible product. 

7 ‘‘(7) QUALIFIED RESEARCH.—The term ‘quali8 fied research’ means— 

9 ‘‘(A) research in furtherance of an applica10 tion under section 505(b) or (j) of this Act; 

11 ‘‘(B) research in furtherance of an applica12 tion for a license under section 351(a) or (k) of 

13 the Public Health Service Act; 

14 ‘‘(C) research for which an exemption for 

15 investigational use is granted pursuant to sec16 tion 505(i) of this Act or section 351(a) of the 

17 Public Health Service Act; or 

18 ‘‘(D) research using an approved drug for 

19 an approved indication with the purpose of eval20 uating and comparing the clinical effectiveness, 

21 risks, or benefits of 2 or more of any of the fol22 lowing: 

23 ‘‘(i) Health care interventions, proto24 cols for treatment, care management, deVerDate Sep 11 2014 00:14 Apr 09, 2022 Jkt 029200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S4053.IS S4053

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1 livery procedures, diagnostic tools, or inte2 grative practices. 

3 ‘‘(ii) Drugs (including biological prod4 ucts), devices, or combination products. 

5 ‘‘(iii) Any other treatments, services, 

6 practices, or items being used in the treat7 ment, management, or diagnosis of, or pre8 vention of, illness or injury in individuals. 

9 ‘‘(8) SUFFICIENT QUANTITY.—The term ‘suffi10 cient quantity’ means an amount of an eligible prod11 uct no greater than the eligible researcher deter12 mines to be necessary to accomplish the qualified re13 search and fulfill any related regulatory require14 ments.’’. 

15 (b) REGULATIONS.—Not later than 180 days of the 

16 date of enactment of this Act, the Secretary of Health and 

17 Human Services shall promulgate final regulations to 

18 carry out section 505–3 of the Federal Food, Drug, and 

19 Cosmetic Act, as added by subsection (a), including regu20 lations to appropriately calculate the discounted price ap21 plicable with respect to an eligible product (as such terms 

22 are defined in such section 505–3). 

Æ 


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