VITAL Act of 2025

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3631 Introduced in House (IH)]

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119th CONGRESS
  1st Session
                                H. R. 3631

  To criminalize fraudulent statements made with respect to clinical
                            vaccine trials.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                              May 29, 2025

    Mr. Green of Tennessee introduced the following bill; which was
 referred to the Committee on Energy and Commerce, and in addition to
    the Committee on the Judiciary, 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 committee concerned

_______________________________________________________________________

                                 A BILL

  To criminalize fraudulent statements made with respect to clinical
                            vaccine trials.

    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 ``Vaccines in Trial and Liability Act
of 2025'' or the ``VITAL Act of 2025''.

SEC. 2. MEDICAL RESEARCH COMPANY OR SPONSOR.

    (a) In General.--Chapter 47 of title 18, United States Code, is
amended by adding at the end the following:
``Sec. 1041. Clinical vaccine trial fraud
    ``Whoever, being a medical research company or sponsor, makes a
fraudulent statement to, or conceals from, any department or agency of
the United States, any material data collected from a clinical vaccine
trial, shall be fined under this title, imprisoned not more than 5
years, or both.''.
    (b) Clerical Amendment.--The table of sections for chapter 47 of
title 18, United States Code, is amended by adding at the end the
following:

``1041. Clinical vaccine trial fraud.''.

SEC. 3. SCOPE OF AUTHORIZATION.

    Section 564(c) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb-3(c)) is amended--
            (1) in paragraph (4), by striking ``and'';
            (2) by redesignating paragraph (5) as paragraph (6); and
            (3) by inserting after paragraph (4) the following:
            ``(5) the authorization is based on a certification by a
        medical research company or sponsor that no fraudulent material
        statements were made, and no material information was
        concealed, with respect to the circumstances described under
        subsection (b)(1) or the criteria under this subsection; and''.

SEC. 4. REVISION AND REVOCATION.

    Section 564(g)(2) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb-3(g)(2)) is amended--
            (1) in subparagraph (B), by striking ``or'' at the end;
            (2) by redesignating subparagraph (C) as subparagraph (D);
        and
            (3) by inserting after subparagraph (B) the following:
                    ``(C) the Secretary determines that fraudulent
                material statements were made, or material information
                was concealed, with respect to the circumstances
                described under subsection (b)(1) or the criteria under
                subsection (c); or''.

SEC. 5. EXCEPTION TO LIMITATION ON LIABILITY.

    Section 2(b)(1) of the Trickett Wendler, Frank Mongiello, Jordan
McLinn, and Matthew Bellina Right to Try Act of 2017 (21 U.S.C. 360bbb-
0a note) is amended--
            (1) in subparagraph (A), by inserting ``, unless a
        fraudulent material statement was made, or material information
        was concealed, with respect to data collected from a clinical
        trial of the investigational drug'' before the semicolon; and
            (2) in subparagraph (B), by inserting ``, including a
        fraudulent material statement made, or material information
        concealed, with respect to data collected from a clinical trial
        of the investigational drug'' before the period.

SEC. 6. EXCEPTION TO TARGETED LIABILITY PROTECTIONS FOR PANDEMIC AND
              EPIDEMIC PRODUCTS.

    Section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d)
is amended--
            (1) in subsection (c)--
                    (A) in paragraph (1)(A)--
                            (i) by redesignating clauses (i), (ii), and
                        (iii) as subclauses (I), (II), and (III),
                        respectively;
                            (ii) by moving subclauses (I), (II), and
                        (III), as redesignated, 2 ems to the right;
                            (iii) by striking the period at the end of
                        subclause (III) and inserting ``; and'', as
                        redesignated;
                            (iv) by striking ``subsection (d), denote''
                        and inserting the following: ``subsection (d)--
                            ``(i) denote''; and
                            (v) by adding at the end the following:
                            ``(ii) includes--
                                    ``(I) making a fraudulent material
                                statement with respect to data
                                collected from a clinical trial; or
                                    ``(II) concealing material
                                information with respect to data
                                collected from a clinical trial.''; and
                    (B) in paragraph (5)(A)--
                            (i) in the matter preceding clause (i), by
                        striking ``subsection (d) if--'' and inserting
                        ``subsection (d)--'';
                            (ii) in clause (i)--
                                    (I) by inserting ``if'' before
                                ``neither''; and
                                    (II) by striking ``or'' at the end;
                            (iii) in clause (ii)--
                                    (I) by inserting ``if'' before
                                ``such an enforcement''; and
                                    (II) by striking the period at the
                                end and inserting ``; and''; and
                            (iv) by adding at the end the following:
                            ``(iii) unless the Secretary determines,
                        after notice and opportunity for a hearing,
                        that a fraudulent material statement was made,
                        or material information was concealed, by a
                        covered person with respect to data collected
                        from a clinical trial of a covered
                        countermeasure.''; and
            (2) in subsection (e)--
                    (A) by striking paragraph (7); and
                    (B) by adding at the end the following:
            ``(11) Award of damages.--Notwithstanding any other
        provision of law, the amount of an award of damages made to a
        plaintiff may not be reduced because of any other award for
        damages the plaintiff may receive as a result of such claim.''.

SEC. 7. NATIONAL VACCINE INJURY COMPENSATION PROGRAM.

    Section 2122 of the Public Health Service Act (42 U.S.C. 300aa-22)
is amended by adding at the end the following:
    ``(f) Liability.--
            ``(1) Fraudulent material statement.--No civil action
        against a vaccine manufacturer or vaccine sponsor shall be
        barred under this part if the Secretary determines, after
        notice and opportunity for a hearing, that a fraudulent
        material statement was made, or material information was
        concealed, by a vaccine manufacturer with respect to data
        collected from a clinical trial of a vaccine.
            ``(2) Award of damages.--
                    ``(A) In general.--Notwithstanding any other
                provision of law, an plaintiff bringing a claim
                pursuant to paragraph (1) may--
                            ``(i) seek compensation under the program
                        established under this part; and
                            ``(ii) concurrently bring an action with
                        respect to such claim in any appropriate United
                        States district court.
                    ``(B) Award of damages.--Notwithstanding any other
                provision of law, the amount of an award of damages
                made to a plaintiff for a claim pursuant to paragraph
                (1) may not be reduced on the basis of any other
                damages the plaintiff may receive as a result of such
                claim.
            ``(3) Applicability with respect to covid-19 vaccine.--
        Notwithstanding any other provision of law, a civil action
        against a vaccine manufacturer pursuant to paragraph (1) with
        respect to a vaccine related to COVID-19 may be made at any
        time.
            ``(4) COVID-19 definition.--In this section, the term
        `COVID-19' means the coronavirus disease caused by the severe
        acute respiratory syndrome coronavirus 2 or the SARS-CoV-2.
        This term also relates to any and all variations of that virus
        of which there is no termination date for this term.''

SEC. 8. LIABILITY HEARING.

    (a) Fraudulent Material or Statements.--In the case that the
Secretary of Health and Human Services determines that a vaccine
manufacturer or vaccine sponsor has made fraudulent material or
statements or concealed material information with respect to a
situation described in this Act, or an amendment made by this Act, the
Secretary shall and provide such manufacturer or sponsor 30 days to
refute a determination made in a hearing described in subsection (b).
    (b) Hearing.--
            (1) In general.--The Secretary shall determine a date,
        time, and format for a hearing under this subsection, including
        a requirement that the vaccine manufacturer or vaccine sponsor
        provide any requested document to the Secretary not more than
        five days before the hearing.
            (2) Format.--The format of a hearing under paragraph (1)
        shall be determined by the Secretary.
            (3) Publication.--Any written or verbal testimony submitted
        by the vaccine manufacturer or vaccine sponsor at the hearing
        under paragraph (1) shall be published on the internet website
        of the Secretary of Health and Human Services.
    (c) Does Not Provide Information.--In the case that the vaccine
manufacturer or vaccine sponsor does not respond to the Secretary in
accordance with this section, an initial determination of fraud shall
be maintained and shall have the full force and effect of this Act.
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