II 118TH CONGRESS 1ST SESSION S. 1476 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 MAY 9, 2023 Ms. STABENOW (for herself, Ms. SMITH, and Mr. WELCH) introduced the fol- lowing 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. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Pharmaceutical Re- 4 search Transparency Act of 2023’’. 5 VerDate Sep 11 2014 00:24 May 16, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1476.IS S1476 kjohnson on DSK79L0C42PROD with BILLS 2 •S 1476 IS SEC. 2. EXPANSION OF REGISTRY AND RESULTS DATA 1 BANK TO INCLUDE COSTS OF DRUG CLINICAL 2 TRIALS. 3 (a) IN GENERAL.—Section 402(j) of the Public 4 Health Service Act (42 U.S.C. 282(j)) is amended— 5 (1) by redesignating paragraph (7) as para- 6 graph (8); and 7 (2) by inserting after paragraph (6) the fol- 8 lowing new paragraph: 9 ‘‘(7) CREATION OF CLINICAL TRIAL COST DATA 10 REPOSITORY.— 11 ‘‘(A) GENERALLY.—The Secretary, acting 12 through the Director of NIH, shall create a 13 publicly available Federal website to serve as a 14 repository of cost data for all applicable drug 15 clinical trials (in this paragraph referred to as 16 the ‘cost data repository’). Such repository shall 17 be searchable by the following criteria: 18 ‘‘(i) The responsible party or sponsor 19 of the applicable drug clinical trial, or any 20 entity funding the applicable drug clinical 21 trial. 22 ‘‘(ii) The name of the intervention, in- 23 cluding any drug being studied in the ap- 24 plicable drug clinical trial. 25 VerDate Sep 11 2014 00:24 May 16, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1476.IS S1476 kjohnson on DSK79L0C42PROD with BILLS 3 •S 1476 IS ‘‘(iii) The study phase of the applica- 1 ble drug clinical trial. 2 ‘‘(iv) The start date and completion 3 date of the applicable drug clinical trial. 4 ‘‘(v) Such other criteria as the Sec- 5 retary deems appropriate. 6 ‘‘(B) COST DATA DEFINED.—For purposes 7 of this paragraph, the term ‘cost data’ includes 8 the following information: 9 ‘‘(i) The total cost of the applicable 10 drug clinical trial. 11 ‘‘(ii) The cost of the trial per patient. 12 ‘‘(iii) Expenditures for each of the fol- 13 lowing categories: 14 ‘‘(I) Personnel. 15 ‘‘(II) Any intervention or treat- 16 ment that is administered in one or 17 more arms of the applicable drug clin- 18 ical trial. 19 ‘‘(III) Materials and supplies. 20 ‘‘(IV) Health care services pro- 21 vided to subjects. 22 ‘‘(V) Site management. 23 ‘‘(VI) Laboratory. 24 ‘‘(VII) Equipment. 25 VerDate Sep 11 2014 00:24 May 16, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1476.IS S1476 kjohnson on DSK79L0C42PROD with BILLS 4 •S 1476 IS ‘‘(VIII) The allocable portion of 1 any facilities costs, administrative 2 costs, or other costs that are not sole- 3 ly attributable to the applicable drug 4 clinical trial. 5 ‘‘(IX) Such other categories as 6 the Secretary may identify by regula- 7 tion. 8 ‘‘(C) POSTING OF CLINICAL TRIAL COST 9 DATA.— 10 ‘‘(i) IN GENERAL.—Except as pro- 11 vided in clause (iii), each responsible party 12 of an applicable drug clinical trial shall 13 post cost data for that trial to the cost 14 data repository no later than 1 year after 15 the completion date of the trial. 16 ‘‘(ii) FORMAT AND METHODOLOGY OF 17 POSTING.—A cost data posting under 18 clause (i) shall— 19 ‘‘(I) include individual data 20 points for the information required 21 under subparagraphs (B)(i) and 22 (B)(ii), separated by year; 23 ‘‘(II) include individual data 24 points for each category listed under 25 VerDate Sep 11 2014 00:24 May 16, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1476.IS S1476 kjohnson on DSK79L0C42PROD with BILLS 5 •S 1476 IS subparagraph (B)(iii), separated by 1 year; 2 ‘‘(III) limit the cost of the inter- 3 vention or treatment under subpara- 4 graph (B)(iii)(II) to manufacturing 5 costs unless the responsible party of 6 the trial was required to purchase the 7 intervention or treatment from an un- 8 affiliated third party; 9 ‘‘(IV) include detailed docu- 10 mentation and methodology for the 11 calculation of costs identified under 12 subparagraph (B)(iii)(VIII); and 13 ‘‘(V) include a signed certifi- 14 cation that the posted data is com- 15 plete and accurate. 16 ‘‘(iii) DELAYED POSTING OF COST 17 DATA AND EXTENSIONS.— 18 ‘‘(I) SEEKING INITIAL APPROVAL 19 OF DRUG, OR APPROVAL OF A NEW 20 USE.—If the responsible party for an 21 applicable drug clinical trial submits a 22 certification that paragraph (3)(E)(iv) 23 or paragraph (3)(E)(v) applies to 24 such trial, the responsible party shall 25 VerDate Sep 11 2014 00:24 May 16, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1476.IS S1476 kjohnson on DSK79L0C42PROD with BILLS 6 •S 1476 IS post cost data under clause (i) at the 1 time that clinical trial information is 2 required to be submitted under the 3 applicable paragraph. 4 ‘‘(II) EXTENSION FOR GOOD 5 CAUSE.—The Director of NIH may 6 provide an extension of the deadline 7 for posting of cost data under clause 8 (i) if the responsible party for the 9 trial submits to the Director a written 10 request that demonstrates good cause 11 for the extension and provides an esti- 12 mate of the date on which the infor- 13 mation will be posted. The Director of 14 NIH may grant more than one such 15 extension for a clinical trial, but 16 under no circumstances shall an ex- 17 tension under this subclause extend 18 beyond the date that is 18 months 19 after the completion date of the trial. 20 ‘‘(III) EXTENSION TO ESTABLISH 21 NECESSARY INFRASTRUCTURE.—If 22 necessary to establish the necessary 23 infrastructure to accept, organize, and 24 post cost data submitted under clause 25 VerDate Sep 11 2014 00:24 May 16, 2023 Jkt 039200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1476.IS S1476 kjohnson on DSK79L0C42PROD with BILLS 7 •S 1476 IS (i), the Director of NIH may extend 1 the deadline for the posting of cost 2 data under clause (i) to not later than 3 2 years after the date of enactment of 4 the Pharmaceutical Research Trans- 5 parency Act of 2023. 6 ‘‘(IV) RULE OF CONSTRUC- 7 TION.—This clause shall not be con- 8 strued to have any effect on reporting 9 obligations of the responsible party 10 under provisions other than this para- 11 graph. 12 ‘‘(D) LINKING TO COST DATA REPOSI- 13 TORY.— 14 ‘‘(i) CREATION OF FIELD.—The Di- 15 rector of NIH shall create a field within 16 the registry and results data bank to in- 17 clude an electronic link to the relevant cost 18 data posting under subparagraph (C)(i). 19 ‘‘(ii) POSTING.—The responsible party 20 for an applicable drug clinical trial shall 21 post in the field created under clause (i) a 22 link to the relevant cost data posting no 23 later than 5 days after initial posting of 24 the cost data under subparagraph (C)(i). 25 VerDate Sep 11 2014 00:24 May 16, 2023 Jkt 039200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S1476.IS S1476 kjohnson on DSK79L0C42PROD with BILLS 8 •S 1476 IS ‘‘(E) RULEMAKING.— 1 ‘‘(i) IN GENERAL.—The Secretary 2 shall promulgate regulations to carry out 3 this paragraph that include— 4 ‘‘(I) definitions for each category 5 of information identified in subpara- 6 graph (B); 7 ‘‘(II) standards for allocating 8 fixed expenditures across multiple 9 years of an applicable drug clinical 10 trial; 11 ‘‘(III) a standard format for the 12 submission and posting of cost data 13 under this paragraph; 14 ‘‘(IV) procedures, standards, and 15 requirements for the reporting docu- 16 mentation and methodology required 17 under subparagraph (C)(ii)(IV); and 18 ‘‘(V) any other procedures, 19 standards, or requirements necessary 20 to ensure public transparency of cost 21 data as required by this paragraph. 22 ‘‘(ii) INITIAL REGULATIONS.—The 23 Secretary shall— 24 VerDate Sep 11 2014 00:24 May 16, 2023 Jkt 039200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S1476.IS S1476 kjohnson on DSK79L0C42PROD with BILLS 9 •S 1476 IS ‘‘(I) not later than one year after 1 the date of enactment of the Pharma- 2 ceutical Research Transparency Act of 3 2023, propose initial regulations 4 under clause (i); and 5 ‘‘(II) not later than 2 years after 6 such date of enactment, finalize such 7 regulations. 8 ‘‘(F) APPLICABILITY.—The requirements 9 of this paragraph apply only to applicable drug 10 clinical trials with a start date on or after the 11 date of enactment of the Pharmaceutical Re- 12 search Transparency Act of 2023.’’. 13 (b) CONFORMING CHANGES.—Section 402(j) of the 14 Public Health Service Act (42 U.S.C. 282(j)), as amended 15 by subsection (a), is further amended— 16 (1) in paragraph (1)(A)(iv), by striking ‘‘para- 17 graph (2) or under paragraph (3)’’ and inserting 18 ‘‘paragraph (2), (3), or (7)’’; 19 (2) in paragraph (4)— 20 (A) in subparagraph (A), by striking 21 ‘‘paragraph (2) or paragraph (3)’’ and inserting 22 ‘‘paragraph (2), (3), or (7)’’; and 23 (B) in subparagraph (B)(i), by striking 24 ‘‘paragraphs (2) and (3)’’ each place it appears 25 VerDate Sep 11 2014 00:24 May 16, 2023 Jkt 039200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S1476.IS S1476 kjohnson on DSK79L0C42PROD with BILLS 10 •S 1476 IS and inserting ‘‘paragraphs (2), (3), and (7)’’; 1 and 2 (3) in paragraph (5)— 3 (A) in subparagraph (A), by striking 4 ‘‘paragraphs (2) and (3)’’ each place it appears 5 and inserting ‘‘paragraphs (2), (3), and (7)’’; 6 and 7 (B) in subparagraph (E)(i), by striking 8 ‘‘paragraphs (2) or (3)’’ and inserting ‘‘para- 9 graph (2), (3), or (7)’’. 10 SEC. 3. DISCLOSURE OF RESEARCH AND DEVELOPMENT 11 EXPENDITURES BY DRUG MANUFACTURERS. 12 Section 13 of the Securities Exchange Act of 1934 13 (15 U.S.C. 78m) is amended by adding at the end the 14 following: 15 ‘‘(t) DISCLOSURE OF RESEARCH AND DEVELOPMENT 16 EXPENDITURES BY DRUG MANUFACTURERS.— 17 ‘‘(1) DEFINITIONS.—In this subsection: 18 ‘‘(A) DRUG.—The term ‘drug’ means any 19 product for which one or more components have 20 been the subject of any of the following applica- 21 tions filed with the Food and Drug Administra- 22 tion: 23 ‘‘(i) A new drug application (or sup- 24 plemental new drug application) filed 25 VerDate Sep 11 2014 00:24 May 16, 2023 Jkt 039200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S1476.IS S1476 kjohnson on DSK79L0C42PROD with BILLS 11 •S 1476 IS under subsection (b) or (j) of section 505 1 of the Federal Food, Drug, and Cosmetic 2 Act (21 U.S.C. 355). 3 ‘‘(ii) A biologic product application (or 4 supplemental application) filed under sub- 5 section (a) or (k) of section 351 of the 6 Public Health Service Act (42 U.S.C. 7 262). 8 ‘‘(B) DRUG MANUFACTURER ISSUER.—The 9 term ‘drug manufacturer issuer’ means an 10 issuer that— 11 ‘‘(i) is required to file an annual re- 12 port with the Commission under subsection 13 (a); and 14 ‘‘(ii) engages in the development, 15 manufacture, or marketing of any drug. 16 ‘‘(2) DISCLOSURE.— 17 ‘‘(A) IN GENERAL.—Subject to the other 18 provisions of this paragraph, the Commission 19 shall issue rules that require each drug manu- 20 facturer issuer’s annual report under subsection 21 (a) to include information regarding the drug 22 manufacturer issuer’s research and development 23 expenditures with respect to— 24 ‘‘(i) a drug; and 25 VerDate Sep 11 2014 00:24 May 16, 2023 Jkt 039200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S1476.IS S1476 kjohnson on DSK79L0C42PROD with BILLS 12 •S 1476 IS ‘‘(ii) any preliminary research or de- 1 velopment of a drug product or drug sub- 2 stance, as those terms are defined in sec- 3 tion 314.3 of title 21, Code of Federal 4 Regulations (or any successor regulation) 5 for which the drug manufacturer issuer 6 has not submitted an application described 7 in clause (i) or (ii) of paragraph (1)(A). 8 ‘‘(B) INITIAL RULES.—The Commission 9 shall— 10 ‘‘(i) not later than 1 year after the 11 date of enactment of the Pharmaceutical 12 Research Transparency Act of 2023, pro- 13 pose initial rules under subparagraph (A); 14 and 15 ‘‘(ii) not later than 2 years after the 16 date of enactment described in clause (i), 17 finalize the rules required under subpara- 18 graph (A). 19 ‘‘(C) REQUIRED INFORMATION.—The in- 20 formation required under subparagraph (A) 21 shall include total expenditures, which shall be 22 disaggregated to each stage of drug research 23 and development, including— 24 ‘‘(i) basic research; 25 VerDate Sep 11 2014 00:24 May 16, 2023 Jkt 039200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S1476.IS S1476 kjohnson on DSK79L0C42PROD with BILLS 13 •S 1476 IS ‘‘(ii) pre-clinical research; 1 ‘‘(iii) phase I of a clinical investiga- 2 tion of a new drug, as described in section 3 312.21(a) of title 21, Code of Federal Reg- 4 ulations, or any successor regulation; 5 ‘‘(iv) phase II of a clinical investiga- 6 tion of a new drug, as described in section 7 312.21(b) of title 21, Code of Federal Reg- 8 ulations, or any successor regulation; 9 ‘‘(v) phase III of a clinical investiga- 10 tion of a new drug, as described in section 11 312.21(c) of title 21, Code of Federal Reg- 12 ulations, or any successor regulation; and 13 ‘‘(vi) post-market studies or clinical 14 trials required under section 505(o) of the 15 Federal Food, Drug, and Cosmetic Act (21 16 U.S.C. 355(o)). 17 ‘‘(D) LIMITATIONS CALCULATION.—The 18 calculation of expenditure information disclosed 19 under subparagraph (A) shall not include the 20 following information, although such informa- 21 tion may be disclosed separately: 22 ‘‘(i) Costs incurred in connection with 23 licensing agreements or acquiring intellec- 24 tual property. 25 VerDate Sep 11 2014 00:24 May 16, 2023 Jkt 039200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\S1476.IS S1476 kjohnson on DSK79L0C42PROD with BILLS 14 •S 1476 IS ‘‘(ii) The cost of mergers or acquisi- 1 tions. 2 ‘‘(iii) Any intangible costs, including 3 estimates, adjustments, and assumptions 4 related to the risk of failure, or the risk as- 5 sociated with seeking regulatory approval 6 by the Food and Drug Administration or 7 another agency. 8 ‘‘(iv) The estimated cost of capital. 9 ‘‘(3) CONSULTATION IN RULEMAKING.—In 10 issuing rules under this subsection, the Commis- 11 sion— 12 ‘‘(A) shall consult with the Commissioner 13 of Food and Drugs and the Director of the Na- 14 [Text truncated for display. Full text available on Congress.gov.]