I 
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 Com-
mittee on the Judiciary, for a period to be subsequently determined by 
the Speaker, in each case for consideration of such provisions as fall with-
in 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 Representa-
tives 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 fol-
lowing: 
VerDate Sep 11 2014 
22:10 May 30, 2025
Jkt 059200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H3631.IH
H3631
ssavage on LAPJG3WLY3PROD with BILLS
‘‘§ 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 Cos-
metic Act (21 U.S.C. 360bbb–3(c)) is amended— 
(1) in paragraph (4), by striking ‘‘and’’; 
(2) by redesignating paragraph (5) as para-
graph (6); and 
(3) by inserting after paragraph (4) the fol-
lowing: 
‘‘(5) the authorization is based on a certifi-
cation by a medical research company or sponsor 
that no fraudulent material statements were made, 
and no material information was concealed, with re-
spect to the circumstances described under sub-
section (b)(1) or the criteria under this subsection; 
and’’. 
VerDate Sep 11 2014 
22:10 May 30, 2025
Jkt 059200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H3631.IH
H3631
ssavage on LAPJG3WLY3PROD with BILLS
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 sub-
paragraph (D); and 
(3) by inserting after subparagraph (B) the fol-
lowing: 
‘‘(C) the Secretary determines that fraudu-
lent 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 amend-
ed— 
(1) in subparagraph (A), by inserting ‘‘, unless 
a fraudulent material statement was made, or mate-
rial 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 ‘‘, includ-
ing a fraudulent material statement made, or mate-
VerDate Sep 11 2014 
22:10 May 30, 2025
Jkt 059200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H3631.IH
H3631
ssavage on LAPJG3WLY3PROD with BILLS
rial information concealed, with respect to data col-
lected 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), de-
note’’ and inserting the following: ‘‘sub-
section (d)— 
‘‘(i) denote’’; and 
(v) by adding at the end the following: 
‘‘(ii) includes— 
VerDate Sep 11 2014 
22:10 May 30, 2025
Jkt 059200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H3631.IH
H3631
ssavage on LAPJG3WLY3PROD with BILLS
‘‘(I) making a fraudulent mate-
rial statement with respect to data 
collected from a clinical trial; or 
‘‘(II) concealing material infor-
mation 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 in-
serting ‘‘subsection (d)—’’; 
(ii) in clause (i)— 
(I) by inserting ‘‘if’’ before ‘‘nei-
ther’’; 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 fol-
lowing: 
‘‘(iii) unless the Secretary determines, 
after notice and opportunity for a hearing, 
that a fraudulent material statement was 
made, or material information was con-
VerDate Sep 11 2014 
22:10 May 30, 2025
Jkt 059200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H3631.IH
H3631
ssavage on LAPJG3WLY3PROD with BILLS
cealed, by a covered person with respect to 
data collected from a clinical trial of a cov-
ered 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 PRO-
GRAM. 
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 col-
lected from a clinical trial of a vaccine. 
VerDate Sep 11 2014 
22:10 May 30, 2025
Jkt 059200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H3631.IH
H3631
ssavage on LAPJG3WLY3PROD with BILLS
‘‘(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 pro-
gram 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.—Notwith-
standing 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 
VerDate Sep 11 2014 
22:10 May 30, 2025
Jkt 059200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H3631.IH
H3631
ssavage on LAPJG3WLY3PROD with BILLS
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 Sec-
retary shall and provide such manufacturer or sponsor 30 
days to refute a determination made in a hearing de-
scribed in subsection (b). 
(b) HEARING.— 
(1) IN GENERAL.—The Secretary shall deter-
mine 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 testi-
mony submitted by the vaccine manufacturer or vac-
cine sponsor at the hearing under paragraph (1) 
VerDate Sep 11 2014 
22:10 May 30, 2025
Jkt 059200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6201
E:\BILLS\H3631.IH
H3631
ssavage on LAPJG3WLY3PROD with BILLS
shall be published on the internet website of the Sec-
retary 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. 
Æ 
VerDate Sep 11 2014 
22:10 May 30, 2025
Jkt 059200
PO 00000
Frm 00009
Fmt 6652
Sfmt 6301
E:\BILLS\H3631.IH
H3631
ssavage on LAPJG3WLY3PROD with BILLS