II 

117TH CONGRESS 

2D SESSION S. 4037 

To amend the Public Health Service Act to increase the transparency of 

pharmaceutical research costs, 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 Public Health Service Act to increase the 

transparency of pharmaceutical research costs, 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 ‘‘Pharmaceutical Re5 search Transparency Act of 2022’’. 


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1 SEC. 2. EXPANSION OF REGISTRY AND RESULTS DATA 

2 BANK TO INCLUDE COSTS OF DRUG CLINICAL 

3 TRIALS. 

4 (a) IN GENERAL.—Section 402(j) of the Public 

5 Health Service Act (42 U.S.C. 282(j)) is amended— 

6 (1) by redesignating paragraph (7) as para7 graph (8); and 

8 (2) by inserting after paragraph (6) the fol9 lowing new paragraph: 

10 ‘‘(7) CREATION OF CLINICAL TRIAL COST DATA

11 REPOSITORY.— 

12 ‘‘(A) GENERALLY.—The Secretary, acting 

13 through the Director of NIH, shall create a 

14 publicly available Federal website to serve as a 

15 repository of cost data for all applicable drug 

16 clinical trials (in this paragraph referred to as 

17 the ‘cost data repository’). Such repository shall 

18 be searchable by the following criteria: 

19 ‘‘(i) The responsible party or sponsor 

20 of the applicable drug clinical trial, or any 

21 entity funding the applicable drug clinical 

22 trial. 

23 ‘‘(ii) The name of the intervention, in24 cluding any drug being studied in the ap25 plicable drug clinical trial. 


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1 ‘‘(iii) The study phase of the applica2 ble drug clinical trial. 

3 ‘‘(iv) The start date and completion 

4 date of the applicable drug clinical trial. 

5 ‘‘(v) Such other criteria as the Sec6 retary deems appropriate. 

7 ‘‘(B) COST DATA DEFINED.—For purposes 

8 of this paragraph, the term ‘cost data’ includes 

9 the following information: 

10 ‘‘(i) The total cost of the applicable 

11 drug clinical trial. 

12 ‘‘(ii) The cost of the trial per patient. 

13 ‘‘(iii) Expenditures for each of the fol14 lowing categories: 

15 ‘‘(I) Personnel. 

16 ‘‘(II) Any intervention or treat17 ment that is administered in one or 

18 more arms of the applicable drug clin19 ical trial. 

20 ‘‘(III) Materials and supplies. 

21 ‘‘(IV) Health care services pro22 vided to subjects. 

23 ‘‘(V) Site management. 

24 ‘‘(VI) Laboratory. 

25 ‘‘(VII) Equipment. 


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1 ‘‘(VIII) The allocable portion of 

2 any facilities costs, administrative 

3 costs, or other costs that are not sole4 ly attributable to the applicable drug 

5 clinical trial. 

6 ‘‘(IX) Such other categories as 

7 the Secretary may identify by regula8 tion. 

9 ‘‘(C) POSTING OF CLINICAL TRIAL COST

10 DATA.— 

11 ‘‘(i) IN GENERAL.—Except as pro12 vided in clause (iii), each responsible party 

13 of an applicable drug clinical trial shall 

14 post cost data for that trial to the cost 

15 data repository no later than 1 year after 

16 the completion date of the trial. 

17 ‘‘(ii) FORMAT AND METHODOLOGY OF

18 POSTING.—A cost data posting under 

19 clause (i) shall— 

20 ‘‘(I) include individual data 

21 points for the information required 

22 under subparagraphs (B)(i) and 

23 (B)(ii), separated by year; 

24 ‘‘(II) include individual data 

25 points for each category listed under 


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1 subparagraph (B)(iii), separated by 

2 year; 

3 ‘‘(III) limit the cost of the inter4 vention or treatment under subpara5 graph (B)(iii)(II) to manufacturing 

6 costs unless the responsible party of 

7 the trial was required to purchase the 

8 intervention or treatment from an un9 affiliated third party; 

10 ‘‘(IV) include detailed docu11 mentation and methodology for the 

12 calculation of costs identified under 

13 subparagraph (B)(iii)(VIII); and 

14 ‘‘(V) include a signed certifi15 cation that the posted data is com16 plete and accurate. 

17 ‘‘(iii) DELAYED POSTING OF COST

18 DATA AND EXTENSIONS.— 

19 ‘‘(I) SEEKING INITIAL APPROVAL

20 OF DRUG, OR APPROVAL OF A NEW

21 USE.—If the responsible party for an 

22 applicable drug clinical trial submits a 

23 certification that paragraph (3)(E)(iv) 

24 or paragraph (3)(E)(v) applies to 

25 such trial, the responsible party shall 


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1 post cost data under clause (i) at the 

2 time that clinical trial information is 

3 required to be submitted under the 

4 applicable paragraph. 

5 ‘‘(II) EXTENSION FOR GOOD

6 CAUSE.—The Director of NIH may 

7 provide an extension of the deadline 

8 for posting of cost data under clause 

9 (i) if the responsible party for the 

10 trial submits to the Director a written 

11 request that demonstrates good cause 

12 for the extension and provides an esti13 mate of the date on which the infor14 mation will be posted. The Director of 

15 NIH may grant more than one such 

16 extension for a clinical trial, but 

17 under no circumstances shall an ex18 tension under this subclause extend 

19 beyond the date that is 18 months 

20 after the completion date of the trial. 

21 ‘‘(III) EXTENSION TO ESTABLISH

22 NECESSARY INFRASTRUCTURE.—If 

23 necessary to establish the necessary 

24 infrastructure to accept, organize, and 

25 post cost data submitted under clause 


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1 (i), the Director of NIH may extend 

2 the deadline for the posting of cost 

3 data under clause (i) to not later than 

4 2 years after the date of enactment of 

5 the Pharmaceutical Research Trans6 parency Act of 2022. 

7 ‘‘(IV) RULE OF CONSTRUC8 TION.—This clause shall not be con9 strued to have any effect on reporting 

10 obligations of the responsible party 

11 under provisions other than this para12 graph. 

13 ‘‘(D) LINKING TO COST DATA REPOSI14 TORY.— 

15 ‘‘(i) CREATION OF FIELD.—The Di16 rector of NIH shall create a field within 

17 the registry and results data bank to in18 clude an electronic link to the relevant cost 

19 data posting under subparagraph (C)(i). 

20 ‘‘(ii) POSTING.—The responsible party 

21 for an applicable drug clinical trial shall 

22 post in the field created under clause (i) a 

23 link to the relevant cost data posting no 

24 later than 5 days after initial posting of 

25 the cost data under subparagraph (C)(i). 


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1 ‘‘(E) RULEMAKING.— 

2 ‘‘(i) IN GENERAL.—The Secretary 

3 shall promulgate regulations to carry out 

4 this paragraph that include— 

5 ‘‘(I) definitions for each category 

6 of information identified in subpara7 graph (B); 

8 ‘‘(II) standards for allocating 

9 fixed expenditures across multiple 

10 years of an applicable drug clinical 

11 trial; 

12 ‘‘(III) a standard format for the 

13 submission and posting of cost data 

14 under this paragraph; 

15 ‘‘(IV) procedures, standards, and 

16 requirements for the reporting docu17 mentation and methodology required 

18 under subparagraph (C)(ii)(IV); and 

19 ‘‘(V) any other procedures, 

20 standards, or requirements necessary 

21 to ensure public transparency of cost 

22 data as required by this paragraph. 

23 ‘‘(ii) INITIAL REGULATIONS.—The 

24 Secretary shall— 


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1 ‘‘(I) not later than one year after 

2 the date of enactment of the Pharma3 ceutical Research Transparency Act of 

4 2022, propose initial regulations 

5 under clause (i); and 

6 ‘‘(II) not later than 2 years after 

7 such date of enactment, finalize such 

8 regulations. 

9 ‘‘(F) APPLICABILITY.—The requirements 

10 of this paragraph apply only to applicable drug 

11 clinical trials with a start date on or after the 

12 date of enactment of the Pharmaceutical Re13 search Transparency Act of 2022.’’. 

14 (b) CONFORMING CHANGES.—Section 402(j) of the 

15 Public Health Service Act (42 U.S.C. 282(j)), as amended 

16 by subsection (a), is further amended— 

17 (1) in paragraph (1)(A)(iv), by striking ‘‘para18 graph (2) or under paragraph (3)’’ and inserting 

19 ‘‘paragraph (2), (3), or (7)’’; 

20 (2) in paragraph (4)— 

21 (A) in subparagraph (A), by striking 

22 ‘‘paragraph (2) or paragraph (3)’’ and inserting 

23 ‘‘paragraph (2), (3), or (7)’’; and 

24 (B) in subparagraph (B)(i), by striking 

25 ‘‘paragraphs (2) and (3)’’ each place it appears 


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1 and inserting ‘‘paragraphs (2), (3), and (7)’’; 

2 and 

3 (3) in paragraph (5)— 

4 (A) in subparagraph (A), by striking 

5 ‘‘paragraphs (2) and (3)’’ each place it appears 

6 and inserting ‘‘paragraphs (2), (3), and (7)’’; 

7 and 

8 (B) in subparagraph (E)(i), by striking 

9 ‘‘paragraphs (2) or (3)’’ and inserting ‘‘para10 graph (2), (3), or (7)’’. 

11 SEC. 3. DISCLOSURE OF RESEARCH AND DEVELOPMENT 

12 EXPENDITURES BY DRUG MANUFACTURERS. 

13 Section 13 of the Securities Exchange Act of 1934 

14 (15 U.S.C. 78m) is amended by adding at the end the 

15 following: 

16 ‘‘(s) DISCLOSURE OF RESEARCH AND DEVELOPMENT

17 EXPENDITURES BY DRUG MANUFACTURERS.— 

18 ‘‘(1) DEFINITIONS.—In this subsection: 

19 ‘‘(A) DRUG.—The term ‘drug’ means any 

20 product for which one or more components have 

21 been the subject of any of the following applica22 tions filed with the Food and Drug Administra23 tion: 

24 ‘‘(i) A new drug application (or sup25 plemental new drug application) filed 


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1 under subsection (b) or (j) of section 505 

2 of the Federal Food, Drug, and Cosmetic 

3 Act (21 U.S.C. 355). 

4 ‘‘(ii) A biologic product application (or 

5 supplemental application) filed under sub6 section (a) or (k) of section 351 of the 

7 Public Health Service Act (42 U.S.C. 

8 262). 

9 ‘‘(B) DRUG MANUFACTURER ISSUER.—The 

10 term ‘drug manufacturer issuer’ means an 

11 issuer that— 

12 ‘‘(i) is required to file an annual re13 port with the Commission under subsection 

14 (a); and 

15 ‘‘(ii) engages in the development, 

16 manufacture, or marketing of any drug. 

17 ‘‘(2) DISCLOSURE.— 

18 ‘‘(A) IN GENERAL.—Subject to the other 

19 provisions of this paragraph, the Commission 

20 shall issue rules that require each drug manu21 facturer issuer’s annual report under subsection 

22 (a) to include information regarding the drug 

23 manufacturer issuer’s research and development 

24 expenditures with respect to— 

25 ‘‘(i) a drug; and 


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1 ‘‘(ii) any preliminary research or de2 velopment of a drug product or drug sub3 stance, as those terms are defined in sec4 tion 314.3 of title 21, Code of Federal 

5 Regulations (or any successor regulation) 

6 for which the drug manufacturer issuer 

7 has not submitted an application described 

8 in clause (i) or (ii) of paragraph (1)(A). 

9 ‘‘(B) INITIAL RULES.—The Commission 

10 shall— 

11 ‘‘(i) not later than 1 year after the 

12 date of enactment of the Pharmaceutical 

13 Research Transparency Act of 2022, pro14 pose initial rules under subparagraph (A); 

15 and 

16 ‘‘(ii) not later than 2 years after the 

17 date of enactment described in clause (i), 

18 finalize the rules required under subpara19 graph (A). 

20 ‘‘(C) REQUIRED INFORMATION.—The in21 formation required under subparagraph (A) 

22 shall include total expenditures, which shall be 

23 disaggregated to each stage of drug research 

24 and development, including— 

25 ‘‘(i) basic research; 


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1 ‘‘(ii) pre-clinical research; 

2 ‘‘(iii) phase I of a clinical investiga3 tion of a new drug, as described in section 

4 312.21(a) of title 21, Code of Federal Reg5 ulations, or any successor regulation; 

6 ‘‘(iv) phase II of a clinical investiga7 tion of a new drug, as described in section 

8 312.21(b) of title 21, Code of Federal Reg9 ulations, or any successor regulation; 

10 ‘‘(v) phase III of a clinical investiga11 tion of a new drug, as described in section 

12 312.21(c) of title 21, Code of Federal Reg13 ulations, or any successor regulation; and 

14 ‘‘(vi) post-market studies or clinical 

15 trials required under section 505(o) of the 

16 Federal Food, Drug, and Cosmetic Act (21 

17 U.S.C. 355(o)). 

18 ‘‘(D) LIMITATIONS CALCULATION.—The 

19 calculation of expenditure information disclosed 

20 under subparagraph (A) shall not include the 

21 following information, although such informa22 tion may be disclosed separately: 

23 ‘‘(i) Costs incurred in connection with 

24 licensing agreements or acquiring intellec25 tual property. 


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1 ‘‘(ii) The cost of mergers or acquisi2 tions. 

3 ‘‘(iii) Any intangible costs, including 

4 estimates, adjustments, and assumptions 

5 related to the risk of failure, or the risk as6 sociated with seeking regulatory approval 

7 by the Food and Drug Administration or 

8 another agency. 

9 ‘‘(iv) The estimated cost of capital. 

10 ‘‘(3) CONSULTATION IN RULEMAKING.—In 

11 issuing rules under this subsection, the Commis12 sion— 

13 ‘‘(A) shall consult with the Commissioner 

14 of Food and Drugs and the Director of the Na15 tional Institutes of Health; and 

16 ‘‘(B) may consult with the head of any 

17 other Federal agency or entity that the Com18 mission determines is relevant.’’. 

19 SEC. 4. SEVERABILITY. 

20 If any provision of this Act, an amendment made by 

21 this Act, or the application of any such provision or 

22 amendment to any person or circumstance is held to be 

23 unconstitutional, the remainder of the provisions of this 

24 Act, the amendments made by this Act, and the applicaVerDate Sep 11 2014 22:05 Apr 08, 2022 Jkt 029200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\S4037.IS S4037

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1 tion of such provisions and amendments to any person or 

2 circumstance shall not be affected thereby. 

Æ 


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