Pharmaceutical Research Transparency Act of 2023

Subjects: Health

Summary:  <p><strong>Pharmaceutical Research Transparency Act of 2023</strong></p> <p>This bill requires the disclosure of costs associated with clinical trials and pharmaceutical research and development.</p> <p>Specifically, the National Institutes of Health must create a publicly available repository of cost data from certain clinical trials that test the efficacy of drugs, biological products, and devices in human subjects. For each applicable trial, the registry must, among other information, include the total and per patient cost of the trial, as well as costs for personnel, health care services, and other categories of expenditures. Information must be added to the registry within one year of the trial's completion.</p> <p>The bill also requires drug manufacturers to include their research and development expenditures for drugs and biological products in annual disclosures made to the Securities and Exchange Commission.</p>

<html><body><pre>[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 1476 Introduced in Senate (IS)]

&lt;DOC&gt;






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 
 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 2023''.

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 2023.
                                    ``(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 2023, 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 
                2023.''.
    (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:
    ``(t) 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 2023, 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.
                                 &lt;all&gt;
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