I 

118TH CONGRESS 

2D SESSION H. R. 8380 

To criminalize fraudulent statements made with respect to clinical vaccine 

trials. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 14, 2024 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Vaccines In Trial And 

5 Liability Act of 2024’’ or the ‘‘VITAL Act of 2024’’. 

6 SEC. 2. MEDICAL RESEARCH COMPANY OR SPONSOR. 

7 (a) IN GENERAL.—Chapter 47 of title 18, United 

8 States Code, is amended by adding at the end the fol9 lowing: 


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1 ‘‘§ 1041. Clinical vaccine trial fraud 

2 ‘‘Whoever, being a medical research company or 

3 sponsor, makes a fraudulent statement to, or conceals 

4 from, any department or agency of the United States, any 

5 material data collected from a clinical vaccine trial, shall 

6 be fined under this title, imprisoned not more than 5 

7 years, or both.’’. 

8 (b) CLERICAL AMENDMENT.—The table of sections 

9 for chapter 47 of title 18, United States Code, is amended 

10 by adding at the end the following: 

‘‘1041. Clinical vaccine trial fraud.’’. 

11 SEC. 3. SCOPE OF AUTHORIZATION. 

12 Section 564(c) of the Federal Food, Drug, and Cos13 metic Act (21 U.S.C. 360bbb–3(c)) is amended— 

14 (1) in paragraph (4), by striking ‘‘and’’ 

15 (2) by redesignating paragraph (5) as para16 graph (6); and 

17 (3) by inserting after paragraph (4) the fol18 lowing: 

19 ‘‘(5) the authorization is based on a certifi20 cation by a medical research company or sponsor 

21 that no fraudulent material statements were made, 

22 and no material information was concealed, with re23 spect to the circumstances described under sub24 section (b)(1) or the criteria under this subsection; 

25 and’’. 


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1 SEC. 4. REVISION AND REVOCATION. 

2 Section 564(g)(2) of the Federal Food, Drug, and 

3 Cosmetic Act (21 U.S.C. 360bbb–3(g)(2)) is amended— 

4 (1) in subparagraph (B), by striking ‘‘or’’ at 

5 the end; 

6 (2) by redesignating subparagraph (C) as sub7 paragraph (D); and 

8 (3) by inserting after subparagraph (B) the fol9 lowing: 

10 ‘‘(C) the Secretary determines that fraudu11 lent material statements were made, or material 

12 information was concealed, with respect to the 

13 circumstances described under subsection (b)(1) 

14 or the criteria under subsection (c); or’’. 

15 SEC. 5. EXCEPTION TO LIMITATION ON LIABILITY. 

16 Section 2(b)(1) of the Trickett Wendler, Frank 

17 Mongiello, Jordan McLinn, and Matthew Bellina Right to 

18 Try Act of 2017 (21 U.S.C. 360bbb–0a note) is amend19 ed— 

20 (1) in subparagraph (A), by inserting ‘‘, unless 

21 a fraudulent material statement was made, or mate22 rial information was concealed, with respect to data 

23 collected from a clinical trial of the investigational 

24 drug’’ before the semicolon; and 

25 (2) in subparagraph (B), by inserting ‘‘, includ26 ing a fraudulent material statement made, or mateVerDate Sep 11 2014 05:02 Jun 14, 2024 Jkt 049200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H8380.IH H8380

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1 rial information concealed, with respect to data col2 lected from a clinical trial of the investigational 

3 drug’’ before the period. 

4 SEC. 6. EXCEPTION TO TARGETED LIABILITY PROTECTIONS 

5 FOR PANDEMIC AND EPIDEMIC PRODUCTS. 

6 Section 319F–3 of the Public Health Service Act (42 

7 U.S.C. 247d–6d(c)) is amended— 

8 (1) in subsection (c)— 

9 (A) in paragraph (1)(A)— 

10 (i) by redesignating clauses (i), (ii), 

11 and (iii) as subclauses (I), (II), and (III), 

12 respectively; 

13 (ii) by moving subclauses (I), (II), 

14 and (III), as redesignated, 2 ems to the 

15 right; 

16 (iii) by striking the period at the end 

17 of subclause (III), as redesignated; 

18 (iv) by striking ‘‘subsection (d), de19 note’’ and inserting the following: ‘‘sub20 section (d)— 

21 ‘‘(i) denote’’; and 

22 (v) by adding at the end the following: 

23 ‘‘(ii) includes— 


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1 ‘‘(I) making a fraudulent mate2 rial statement with respect to data 

3 collected from a clinical trial; or 

4 ‘‘(II) concealing material infor5 mation with respect to data collected 

6 from a clinical trial.’’; and 

7 (B) in paragraph (5)(A)— 

8 (i) in the matter preceding clause (i), 

9 by striking ‘‘subsection (d) if—’’ and in10 serting ‘‘subsection (d)—’’; 

11 (ii) in clause (i)— 

12 (I) by inserting ‘‘if’’ before ‘‘nei13 ther’’; and 

14 (II) by striking ‘‘or’’ at the end; 

15 (iii) in clause (ii)— 

16 (I) by inserting ‘‘if’’ before ‘‘such 

17 an enforcement’’; and 

18 (II) by striking the period at the 

19 end and inserting ‘‘; and’’; and 

20 (iv) by adding at the end the fol21 lowing: 

22 ‘‘(iii) unless the Secretary determines, 

23 after notice and opportunity for a hearing, 

24 that a fraudulent material statement was 

25 made, or material information was conVerDate Sep 11 2014 05:02 Jun 14, 2024 Jkt 049200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H8380.IH H8380

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1 cealed, by a covered person with respect to 

2 data collected from a clinical trial of a cov3 ered countermeasure.’’; 

4 (2) in subsection (d) by adding at the end the 

5 following: 

6 ‘‘(11) AWARD OF DAMAGES.—Notwithstanding 

7 any other provision of law, the amount of an award 

8 of damages made to a plaintiff may not be reduced 

9 because of any other award for damages the plaintiff 

10 may receive as a result of such claim.’’; and 

11 (3) subsection (e), by striking paragraph (7). 

12 SEC. 7. NATIONAL VACCINE INJURY COMPENSATION PRO13 GRAM. 

14 Section 2122 of the Public Health Service Act (42 

15 U.S.C. 300aa–22) is amended by adding at the end the 

16 following: 

17 ‘‘(f) LIABILITY.— 

18 ‘‘(1) FRAUDULENT MATERIAL STATEMENT.— 

19 No civil action against a vaccine manufacturer or 

20 vaccine sponsor shall be barred under this part if the 

21 Secretary determines, after notice and opportunity 

22 for a hearing, that a fraudulent material statement 

23 was made, or material information was concealed, by 

24 a vaccine manufacturer with respect to data col25 lected from a clinical trial of a vaccine. 


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1 ‘‘(2) AWARD OF DAMAGES.— 

2 ‘‘(A) IN GENERAL.—Notwithstanding any 

3 other provision of law, an plaintiff bringing a 

4 claim pursuant to paragraph (1) may— 

5 ‘‘(i) seek compensation under the pro6 gram established under this part; and 

7 ‘‘(ii) concurrently bring an action with 

8 respect to such claim in any appropriate 

9 United States district court. 

10 ‘‘(B) AWARD OF DAMAGES.—Notwith11 standing any other provision of law, the amount 

12 of an award of damages made to a plaintiff for 

13 a claim pursuant to paragraph (1) may not be 

14 reduced on the basis of any other damages the 

15 plaintiff may receive as a result of such claim. 

16 ‘‘(3) APPLICABILITY WITH RESPECT TO COVID– 

17 19 VACCINE.—Notwithstanding any other provision 

18 of law, a civil action against a vaccine manufacturer 

19 pursuant to paragraph (1) with respect to a vaccine 

20 related to COVID–19 may be made at any time. 

21 ‘‘(4) COVID–19 DEFINITION.—In this section, 

22 the term ‘COVID–19’ means the coronavirus disease 

23 caused by the severe acute respiratory syndrome 

24 coronavirus 2 or the SARS–CoV–2. This term also 


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1 relates to any and all variations of that virus of 

2 which there is no termination date for this term.’’ 

3 SEC. 8. LIABILITY HEARING. 

4 (a) FRAUDULENT MATERIAL OR STATEMENTS.—In 

5 the case that the Secretary of Health and Human Services 

6 determines that a vaccine manufacturer or vaccine sponsor 

7 has made fraudulent material or statements or concealed 

8 material information with respect to a situation described 

9 in this Act, or an amendment made by this Act, the Sec10 retary shall and provide such manufacturer or sponsor 30 

11 days to refute a determination made in a hearing de12 scribed in subsection (b). 

13 (b) HEARING.— 

14 (1) IN GENERAL.—The Secretary shall deter15 mine a date, time, and format for a hearing under 

16 this subsection, including a requirement that the 

17 vaccine manufacturer or vaccine sponsor provide any 

18 requested document to the Secretary not more than 

19 five days before the hearing. 

20 (2) FORMAT.—The format of a hearing under 

21 paragraph (1) shall be determined by the Secretary. 

22 (3) PUBLICATION.—Any written or verbal testi23 mony submitted by the vaccine manufacturer or vac24 cine sponsor at the hearing under paragraph (1) 


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1 shall be published on the internet website of the Sec2 retary of Health and Human Services. 

3 (c) DOES NOT PROVIDE INFORMATION.—In the case 

4 that the vaccine manufacturer or vaccine sponsor does not 

5 respond to the Secretary in accordance with this section, 

6 an initial determination of fraud shall be maintained and 

7 shall have the full force and effect of this Act. 

Æ 


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