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[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 2486 Introduced in Senate (IS)]

<DOC>

117th CONGRESS
  1st Session
                                S. 2486

 To authorize the use of drugs, vaccines, and medical technologies to 
  expand military and civilian access to such products and to improve 
transparency in taxpayer-funded biomedical research investments by the 
             Department of Defense, and for other purposes.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                             July 27, 2021

  Ms. Warren introduced the following bill; which was read twice and 
              referred to the Committee on Armed Services

_______________________________________________________________________

                                 A BILL

 
 To authorize the use of drugs, vaccines, and medical technologies to 
  expand military and civilian access to such products and to improve 
transparency in taxpayer-funded biomedical research investments by the 
             Department of Defense, 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 ``Make Taxpayer-Funded Department of 
Defense Medical Interventions Affordable Act''.

SEC. 2. AUTHORIZATION OF USE OF DRUGS, VACCINES, AND MEDICAL 
              TECHNOLOGIES TO EXPAND MILITARY AND CIVILIAN ACCESS TO 
              SUCH PRODUCTS.

    (a) Report and Identification of Products.--Not later than one year 
after the date of the enactment of this Act, the Secretary of Defense 
shall submit to the Committees on Armed Services of the Senate and the 
House of Representatives a report on the efforts of the Secretary to 
comply with the paragraph entitled, ``Licensing of Federally owned 
medical interventions'' included on page 173 of the report of the 
Committee on Armed Services of the Senate to accompany the National 
Defense Authorization Act for Fiscal Year 2018 (Public Law 115-91), 
which shall include the following information:
            (1) A description of what steps, if any, the Secretary has 
        taken to comply with that paragraph.
            (2) A complete list of the drugs, vaccines, and medical 
        technologies that, as of the date of the enactment of this Act, 
        meet the requirements outlined in that paragraph.
            (3) For each drug, vaccine, or medical technology 
        identified under paragraph (2), a discussion of the plans of 
        the Secretary to utilize the authorities of the Secretary under 
        section 203 or 209(d)(1) of title 35, United States Code, to 
        authorize a third party or Federal agency to use the drug, 
        vaccine, or medical technology.
    (b) Authorization of Use.--Not later than one year after the date 
of the enactment of this Act, the Secretary of Defense, pursuant to 
section 203 or 209(d)(1) of title 35, United States Code, shall 
authorize third parties or Federal agencies to use not fewer than 10 
drugs, vaccines, or medical technologies identified under subsection 
(a)(2) for the purpose of expanding military and civilian access to 
such drugs, vaccines, or technologies.

SEC. 3. TRANSPARENCY IN TAXPAYER-FUNDED BIOMEDICAL RESEARCH INVESTMENTS 
              BY THE DEPARTMENT OF DEFENSE.

    (a) In General.--The Secretary of Defense shall--
            (1) compile into a searchable database information relating 
        to Federal support (before or after the date of enactment of 
        this Act) provided by the Department of Defense or an entity 
        acting on behalf of the Department of Defense for biomedical 
        research and development, including drugs, vaccines, and 
        medical technologies; and
            (2) make such database available on the public website of 
        the Department of Defense.
    (b) Covered Information.--The information relating to Federal 
support described in subsection (a)(1) shall include all contracts, 
funding agreements, licensing arrangements, other transactions, and 
other arrangements entered into by, or on behalf of, the Department of 
Defense with respect to research and development, manufacturing, and 
distribution of a drug (including a biological product), cell or gene 
therapy, medical device, or other medical technology, including the 
following:
            (1) Licensing agreements pursuant to section 207 or 209 of 
        title 35, United States Code.
            (2) Cooperative research and development agreements and 
        licensing agreements pursuant to section 3710a of title 15, 
        United States Code.
            (3) Funding agreements, as defined in section 201 of title 
        35, United States Code.
            (4) Transactions, contracts, grants, cooperative 
        agreements, other agreements, and other arrangements entered 
        into pursuant to the following:
                    (A) The Public Health Service Act (42 U.S.C. 201 et 
                seq.), including sections 301, 319L, 421, and 480 of 
                such Act (42 U.S.C. 241, 247d-7e, 285b-3, 287a).
                    (B) Section 105 of the National Institutes of 
                Health Reform Act of 2006 (42 U.S.C. 284n).
                    (C) Chapter 139 of title 10, United States Code, 
                including sections 2358, 2371, 2371a, 2371b, and 2373.
    (c) Information Required.--Notwithstanding any other provision of 
law, the Secretary of Defense shall include in the database under 
subsection (a), with regard to each contract, funding agreement, 
licensing agreement, other transaction, or other arrangement described 
in subsection (b), at least the following information:
            (1) The agency, program, institute, or other entity of the 
        Department of Defense providing the Federal grant, cooperative 
        agreement, or other support.
            (2) The amount and period of Federal financial support with 
        an itemized breakdown.
            (3) Other Federal nonfinancial support, including the use 
        of Federal personnel, Federal facilities, and Federal 
        equipment.
            (4) The grant number, if applicable.
            (5) Associated clinical trial data, upon trial completion.
            (6) Associated patents and patent applications, 
        specifying--
                    (A) any Federal ownership in such patents and 
                patent applications;
                    (B) the expiration date of such patents and filing 
                dates of such patent applications; and
                    (C) the numbers of such patents and patent 
                applications.
            (7) Associated periods of marketing exclusivity under 
        Federal law and the durations of such periods.
            (8) The corporation, nonprofit organization, academic 
        institution, person, or other entity receiving the Federal 
        support.
            (9) Any products (including repurposed products) approved, 
        authorized, or cleared for marketing, or for which marketing 
        approval, authorization, or clearance is being sought, the 
        development of which was aided by Federal support, including--
                    (A) the names of such products;
                    (B) the prices of such products; and
                    (C) the current and anticipated manufacturing 
                capacity to produce such products.
            (10) The full terms of the contract, funding agreement, 
        licensing agreement, other transaction, or other arrangement 
        described in subsection (b).
    (d) Format of Information.--The database under subsection (a) shall 
be--
            (1) searchable and filterable according to the categories 
        of information described in subsection (c); and
            (2) presented in a user-friendly format.
    (e) Timing.--The database under subsection (a) shall be--
            (1) made publicly available not later than one month after 
        the date of the enactment of this Act; and
            (2) updated not less frequently than once every two weeks.
    (f) Disclosure.--
            (1) In general.--Notwithstanding any other provision of 
        law, to the extent necessary for the Secretary of Defense to 
        carry out this section, the Secretary may require entities 
        receiving Federal support described in subsection (a)(1) to 
        disclose to the Secretary any information relating to such 
        Federal support and required to be included in the database 
        under subsection (a).
            (2) Intermediary cooperation.--
                    (A) In general.--Any arrangement entered into by 
                the Department of Defense with an entity providing for 
                such entity to enter into contracts, licensing 
                agreements, grants, other transactions, or other 
                arrangements with third parties on behalf of the 
                Department shall require such entity to disclose in a 
                timely manner any information necessary for the 
                Department to fulfill its duties under this section.
                    (B) Existing arrangements.--With respect to any 
                arrangement described in subparagraph (A) with an 
                entity in place as of the date of the enactment of this 
                Act, the Secretary of Defense may require the entity to 
                disclose to the Secretary any information required to 
                be included in the database under subsection (a).
            (3) Penalty for nondisclosure.--If an entity that is 
        required to disclose information pursuant to paragraph (1) or 
        (2) fails to disclose such information by the date that is two 
        weeks after the date on which the Secretary of Defense requests 
        such information, or by such reasonable deadline as the 
        Secretary may specify, whichever is sooner, then such entity 
        shall be liable to the United States for a civil penalty in an 
        amount not to exceed $10,000 for each day on which such failure 
        continues.
                                 <all>
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