I 
117TH CONGRESS 
2D SESSION 
H. R. 7474 
To amend the Public Health Service Act to increase the transparency of 
pharmaceutical research costs, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
APRIL 7, 2022 
Mrs. CAROLYN B. MALONEY of New York (for herself, Ms. SCHAKOWSKY, Mr. 
WELCH, Ms. PORTER, Mr. DESAULNIER, and Mr. RASKIN) introduced 
the following bill; which was referred to the Committee on Energy and 
Commerce, and in addition to the Committee on Financial Services, for 
a period to be subsequently determined by the Speaker, in each case for 
consideration of such provisions as fall within the jurisdiction of the com-
mittee concerned 
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-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Pharmaceutical Re-
search Transparency Act of 2022’’. 
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SEC. 2. EXPANSION OF REGISTRY AND RESULTS DATA 
BANK TO INCLUDE COSTS OF DRUG CLINICAL 
TRIALS. 
(a) IN GENERAL.—Section 402(j) of the Public 
Health Service Act (42 U.S.C. 282(j)) is amended— 
(1) by redesignating paragraph (7) as para-
graph (8); and 
(2) by inserting after paragraph (6) the fol-
lowing new paragraph: 
‘‘(7) CREATION OF CLINICAL TRIAL COST DATA 
REPOSITORY.— 
‘‘(A) GENERALLY.—The Secretary, acting 
through the Director of NIH, shall create a 
publicly available Federal website to serve as a 
repository of cost data for all applicable drug 
clinical trials (in this paragraph referred to as 
the ‘cost data repository’). Such repository shall 
be searchable by the following criteria: 
‘‘(i) The responsible party or sponsor 
of the applicable drug clinical trial, or any 
entity funding the applicable drug clinical 
trial. 
‘‘(ii) The name of the intervention, in-
cluding any drug being studied in the ap-
plicable drug clinical trial. 
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‘‘(iii) The study phase of the applica-
ble drug clinical trial. 
‘‘(iv) The start date and completion 
date of the applicable drug clinical trial. 
‘‘(v) Such other criteria as the Sec-
retary deems appropriate. 
‘‘(B) COST DATA DEFINED.—For purposes 
of this paragraph, the term ‘cost data’ includes 
the following information: 
‘‘(i) The total cost of the applicable 
drug clinical trial. 
‘‘(ii) The cost of the trial per patient. 
‘‘(iii) Expenditures for each of the fol-
lowing categories: 
‘‘(I) Personnel. 
‘‘(II) Any intervention or treat-
ment that is administered in one or 
more arms of the applicable drug clin-
ical trial. 
‘‘(III) Materials and supplies. 
‘‘(IV) Health care services pro-
vided to subjects. 
‘‘(V) Site management. 
‘‘(VI) Laboratory. 
‘‘(VII) Equipment. 
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‘‘(VIII) The allocable portion of 
any facilities costs, administrative 
costs, or other costs that are not sole-
ly attributable to the applicable drug 
clinical trial. 
‘‘(IX) Such other categories as 
the Secretary may identify by regula-
tion. 
‘‘(C) POSTING OF CLINICAL TRIAL COST 
DATA.— 
‘‘(i) IN
GENERAL.—Except as pro-
vided in clause (iii), each responsible party 
of an applicable drug clinical trial shall 
post cost data for that trial to the cost 
data repository no later than 1 year after 
the completion date of the trial. 
‘‘(ii) FORMAT AND METHODOLOGY OF 
POSTING.—A cost data posting under 
clause (i) shall— 
‘‘(I) 
include 
individual 
data 
points for the information required 
under 
subparagraphs 
(B)(i) 
and 
(B)(ii), separated by year; 
‘‘(II) 
include 
individual 
data 
points for each category listed under 
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subparagraph (B)(iii), separated by 
year; 
‘‘(III) limit the cost of the inter-
vention or treatment under subpara-
graph (B)(iii)(II) to manufacturing 
costs unless the responsible party of 
the trial was required to purchase the 
intervention or treatment from an un-
affiliated third party; 
‘‘(IV) 
include 
detailed 
docu-
mentation and methodology for the 
calculation of costs identified under 
subparagraph (B)(iii)(VIII); and 
‘‘(V) include a signed certifi-
cation that the posted data is com-
plete and accurate. 
‘‘(iii) DELAYED
POSTING
OF
COST 
DATA AND EXTENSIONS.— 
‘‘(I) SEEKING INITIAL APPROVAL 
OF DRUG, OR APPROVAL OF A NEW 
USE.—If the responsible party for an 
applicable drug clinical trial submits a 
certification that paragraph (3)(E)(iv) 
or paragraph (3)(E)(v) applies to 
such trial, the responsible party shall 
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post cost data under clause (i) at the 
time that clinical trial information is 
required to be submitted under the 
applicable paragraph. 
‘‘(II) 
EXTENSION
FOR
GOOD 
CAUSE.—The Director of NIH may 
provide an extension of the deadline 
for posting of cost data under clause 
(i) if the responsible party for the 
trial submits to the Director a written 
request that demonstrates good cause 
for the extension and provides an esti-
mate of the date on which the infor-
mation will be posted. The Director of 
NIH may grant more than one such 
extension for a clinical trial, but 
under no circumstances shall an ex-
tension under this subclause extend 
beyond the date that is 18 months 
after the completion date of the trial. 
‘‘(III) EXTENSION TO ESTABLISH 
NECESSARY
INFRASTRUCTURE.—If 
necessary to establish the necessary 
infrastructure to accept, organize, and 
post cost data submitted under clause 
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(i), the Director of NIH may extend 
the deadline for the posting of cost 
data under clause (i) to not later than 
2 years after the date of enactment of 
the Pharmaceutical Research Trans-
parency Act of 2022. 
‘‘(IV) 
RULE
OF
CONSTRUC-
TION.—This clause shall not be con-
strued to have any effect on reporting 
obligations of the responsible party 
under provisions other than this para-
graph. 
‘‘(D) LINKING
TO
COST
DATA
REPOSI-
TORY.— 
‘‘(i) CREATION OF FIELD.—The Di-
rector of NIH shall create a field within 
the registry and results data bank to in-
clude an electronic link to the relevant cost 
data posting under subparagraph (C)(i). 
‘‘(ii) POSTING.—The responsible party 
for an applicable drug clinical trial shall 
post in the field created under clause (i) a 
link to the relevant cost data posting no 
later than 5 days after initial posting of 
the cost data under subparagraph (C)(i). 
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‘‘(E) RULEMAKING.— 
‘‘(i) IN
GENERAL.—The Secretary 
shall promulgate regulations to carry out 
this paragraph that include— 
‘‘(I) definitions for each category 
of information identified in subpara-
graph (B); 
‘‘(II) standards for allocating 
fixed expenditures across multiple 
years of an applicable drug clinical 
trial; 
‘‘(III) a standard format for the 
submission and posting of cost data 
under this paragraph; 
‘‘(IV) procedures, standards, and 
requirements for the reporting docu-
mentation and methodology required 
under subparagraph (C)(ii)(IV); and 
‘‘(V) 
any 
other 
procedures, 
standards, or requirements necessary 
to ensure public transparency of cost 
data as required by this paragraph. 
‘‘(ii) 
INITIAL
REGULATIONS.—The 
Secretary shall— 
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‘‘(I) not later than one year after 
the date of enactment of the Pharma-
ceutical Research Transparency Act of 
2022, 
propose 
initial 
regulations 
under clause (i); and 
‘‘(II) not later than 2 years after 
such date of enactment, finalize such 
regulations. 
‘‘(F) APPLICABILITY.—The requirements 
of this paragraph apply only to applicable drug 
clinical trials with a start date on or after the 
date of enactment of the Pharmaceutical Re-
search Transparency Act of 2022.’’. 
(b) CONFORMING CHANGES.—Section 402(j) of the 
Public Health Service Act (42 U.S.C. 282(j)), as amended 
by subsection (a), is further amended— 
(1) in paragraph (1)(A)(iv), by striking ‘‘para-
graph (2) or under paragraph (3)’’ and inserting 
‘‘paragraph (2), (3), or (7)’’; 
(2) in paragraph (4)— 
(A) in subparagraph (A), by striking 
‘‘paragraph (2) or paragraph (3)’’ and inserting 
‘‘paragraph (2), (3), or (7)’’; and 
(B) in subparagraph (B)(i), by striking 
‘‘paragraphs (2) and (3)’’ each place it appears 
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and inserting ‘‘paragraphs (2), (3), and (7)’’; 
and 
(3) in paragraph (5)— 
(A) in subparagraph (A), by striking 
‘‘paragraphs (2) and (3)’’ each place it appears 
and inserting ‘‘paragraphs (2), (3), and (7)’’; 
and 
(B) in subparagraph (E)(i), by striking 
‘‘paragraphs (2) or (3)’’ and inserting ‘‘para-
graph (2), (3), or (7)’’. 
SEC. 3. DISCLOSURE OF RESEARCH AND DEVELOPMENT 
EXPENDITURES BY DRUG MANUFACTURERS. 
Section 13 of the Securities Exchange Act of 1934 
(15 U.S.C. 78m) is amended by adding at the end the 
following: 
‘‘(s) DISCLOSURE OF RESEARCH AND DEVELOPMENT 
EXPENDITURES BY DRUG MANUFACTURERS.— 
‘‘(1) DEFINITIONS.—In this subsection: 
‘‘(A) DRUG.—The term ‘drug’ means any 
product for which one or more components have 
been the subject of any of the following applica-
tions filed with the Food and Drug Administra-
tion: 
‘‘(i) A new drug application (or sup-
plemental new drug application) filed 
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under subsection (b) or (j) of section 505 
of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355). 
‘‘(ii) A biologic product application (or 
supplemental application) filed under sub-
section (a) or (k) of section 351 of the 
Public Health Service Act (42 U.S.C. 
262). 
‘‘(B) DRUG MANUFACTURER ISSUER.—The 
term ‘drug manufacturer issuer’ means an 
issuer that— 
‘‘(i) is required to file an annual re-
port with the Commission under subsection 
(a); and 
‘‘(ii) engages in the development, 
manufacture, or marketing of any drug. 
‘‘(2) DISCLOSURE.— 
‘‘(A) IN GENERAL.—Subject to the other 
provisions of this paragraph, the Commission 
shall issue rules that require each drug manu-
facturer issuer’s annual report under subsection 
(a) to include information regarding the drug 
manufacturer issuer’s research and development 
expenditures with respect to— 
‘‘(i) a drug; and 
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‘‘(ii) any preliminary research or de-
velopment of a drug product or drug sub-
stance, as those terms are defined in sec-
tion 314.3 of title 21, Code of Federal 
Regulations (or any successor regulation) 
for which the drug manufacturer issuer 
has not submitted an application described 
in clause (i) or (ii) of paragraph (1)(A). 
‘‘(B) INITIAL
RULES.—The Commission 
shall— 
‘‘(i) not later than 1 year after the 
date of enactment of the Pharmaceutical 
Research Transparency Act of 2022, pro-
pose initial rules under subparagraph (A); 
and 
‘‘(ii) not later than 2 years after the 
date of enactment described in clause (i), 
finalize the rules required under subpara-
graph (A). 
‘‘(C) REQUIRED
INFORMATION.—The in-
formation required under subparagraph (A) 
shall include total expenditures, which shall be 
disaggregated to each stage of drug research 
and development, including— 
‘‘(i) basic research; 
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‘‘(ii) pre-clinical research; 
‘‘(iii) phase I of a clinical investiga-
tion of a new drug, as described in section 
312.21(a) of title 21, Code of Federal Reg-
ulations, or any successor regulation; 
‘‘(iv) phase II of a clinical investiga-
tion of a new drug, as described in section 
312.21(b) of title 21, Code of Federal Reg-
ulations, or any successor regulation; 
‘‘(v) phase III of a clinical investiga-
tion of a new drug, as described in section 
312.21(c) of title 21, Code of Federal Reg-
ulations, or any successor regulation; and 
‘‘(vi) post-market studies or clinical 
trials required under section 505(o) of the 
Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(o)). 
‘‘(D) LIMITATIONS
CALCULATION.—The 
calculation of expenditure information disclosed 
under subparagraph (A) shall not include the 
following information, although such informa-
tion may be disclosed separately: 
‘‘(i) Costs incurred in connection with 
licensing agreements or acquiring intellec-
tual property. 
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‘‘(ii) The cost of mergers or acquisi-
tions. 
‘‘(iii) Any intangible costs, including 
estimates, adjustments, and assumptions 
related to the risk of failure, or the risk as-
sociated with seeking regulatory approval 
by the Food and Drug Administration or 
another agency. 
‘‘(iv) The estimated cost of capital. 
‘‘(3) 
CONSULTATION
IN
RULEMAKING.—In 
issuing rules under this subsection, the Commis-
sion— 
‘‘(A) shall consult with the Commissioner 
of Food and Drugs and the Director of the Na-
tional Institutes of Health; and 
‘‘(B) may consult with the head of any 
other Federal agency or entity that the Com-
mission determines is relevant.’’. 
SEC. 4. SEVERABILITY. 
If any provision of this Act, an amendment made by 
this Act, or the application of any such provision or 
amendment to any person or circumstance is held to be 
unconstitutional, the remainder of the provisions of this 
Act, the amendments made by this Act, and the applica-
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