[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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