119-hr3631

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

    (IH) ]

<DOC>

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.
 <all>