[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 4037 Introduced in Senate (IS)]
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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.
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 ``Pharmaceutical Research Transparency
Act of 2022''.
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 paragraph (8); and
(2) by inserting after paragraph (6) the following 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,
including any drug being studied in the
applicable drug clinical trial.
``(iii) The study phase of the applicable
drug clinical trial.
``(iv) The start date and completion date
of the applicable drug clinical trial.
``(v) Such other criteria as the Secretary
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
following categories:
``(I) Personnel.
``(II) Any intervention or
treatment that is administered in one
or more arms of the applicable drug
clinical trial.
``(III) Materials and supplies.
``(IV) Health care services
provided to subjects.
``(V) Site management.
``(VI) Laboratory.
``(VII) Equipment.
``(VIII) The allocable portion of
any facilities costs, administrative
costs, or other costs that are not
solely attributable to the applicable
drug clinical trial.
``(IX) Such other categories as the
Secretary may identify by regulation.
``(C) Posting of clinical trial cost data.--
``(i) In general.--Except as provided 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
subparagraph (B)(iii), separated by
year;
``(III) limit the cost of the
intervention or treatment under
subparagraph (B)(iii)(II) to
manufacturing costs unless the
responsible party of the trial was
required to purchase the intervention
or treatment from an unaffiliated third
party;
``(IV) include detailed
documentation and methodology for the
calculation of costs identified under
subparagraph (B)(iii)(VIII); and
``(V) include a signed
certification that the posted data is
complete 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 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 estimate of
the date on which the information will
be posted. The Director of NIH may
grant more than one such extension for
a clinical trial, but under no
circumstances shall an extension 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
(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
Transparency Act of 2022.
``(IV) Rule of construction.--This
clause shall not be construed to have
any effect on reporting obligations of
the responsible party under provisions
other than this paragraph.
``(D) Linking to cost data repository.--
``(i) Creation of field.--The Director of
NIH shall create a field within the registry
and results data bank to include 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).
``(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
subparagraph (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
documentation 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--
``(I) not later than one year after
the date of enactment of the
Pharmaceutical 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 Research 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 ``paragraph (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 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 ``paragraph
(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 applications filed with the Food
and Drug Administration:
``(i) A new drug application (or
supplemental new drug application) filed 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
subsection (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 report
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 manufacturer 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
``(ii) any preliminary research or
development of a drug product or drug
substance, as those terms are defined in
section 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, propose 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 subparagraph
(A).
``(C) Required information.--The information
required under subparagraph (A) shall include total
expenditures, which shall be disaggregated to each
stage of drug research and development, including--
``(i) basic research;
``(ii) pre-clinical research;
``(iii) phase I of a clinical investigation
of a new drug, as described in section
312.21(a) of title 21, Code of Federal
Regulations, or any successor regulation;
``(iv) phase II of a clinical investigation
of a new drug, as described in section
312.21(b) of title 21, Code of Federal
Regulations, or any successor regulation;
``(v) phase III of a clinical investigation
of a new drug, as described in section
312.21(c) of title 21, Code of Federal
Regulations, 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 information may be disclosed separately:
``(i) Costs incurred in connection with
licensing agreements or acquiring intellectual
property.
``(ii) The cost of mergers or acquisitions.
``(iii) Any intangible costs, including
estimates, adjustments, and assumptions related
to the risk of failure, or the risk associated
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 Commission--
``(A) shall consult with the Commissioner of Food
and Drugs and the Director of the National Institutes
of Health; and
``(B) may consult with the head of any other
Federal agency or entity that the Commission 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
application of such provisions and amendments to any person or
circumstance shall not be affected thereby.
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