I 

118TH CONGRESS 

1ST SESSION H. R. 5773 

To amend the Public Health Service Act to remove certain liability protections 

for certain biological products and other drugs if the sponsor thereof 

fails to disclose to the public all non-exempt data within the biological 

product file or drug application, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

SEPTEMBER 27, 2023 

Mr. POSEY introduced the following bill; which was referred to the Committee 

on Energy and Commerce 

A BILL 

To amend the Public Health Service Act to remove certain 

liability protections for certain biological products and 

other drugs if the sponsor thereof fails to disclose to 

the public all non-exempt data within the biological product file or drug application, and for other purposes. 

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 ‘‘Consumer Vaccine 

5 Safety and Protection Act of 2023’’. 


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1 SEC. 2. DISCLOSURE OF NON-EXEMPT DATA REQUIRED 

2 FOR CERTAIN BIOLOGICAL PRODUCTS AND 

3 OTHER DRUGS. 

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

5 U.S.C. 247d–6b) is amended by adding at the end the fol6 lowing: 

7 ‘‘(j) DISCLOSURE OF NON-EXEMPT DATA RE8 QUIRED.— 

9 ‘‘(1) COVERED PRODUCTS.—In this subsection, 

10 the term ‘covered product’ means a covered counter11 measure that— 

12 ‘‘(A) is a biological product or other drug; 

13 and 

14 ‘‘(B) is authorized for emergency use 

15 under section 564 of the Federal Food, Drug, 

16 and Cosmetic Act on or after the date of enact17 ment of the Consumer Vaccine Safety and Pro18 tection Act of 2023, irrespective of whether the 

19 biological product or drug later receives ap20 proval or licensure under section 505 of the 

21 Federal Food, Drug, and Cosmetic Act or sec22 tion 351 of this Act. 

23 ‘‘(2) DISCLOSURE BY SPONSORS.— 

24 ‘‘(A) IN GENERAL.—Subject to subpara25 graph (C), the sponsor of a covered product 

26 shall disclose to the public, in an easily accesVerDate Sep 11 2014 22:25 Oct 05, 2023 Jkt 049200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H5773.IH H5773

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1 sible location on the website of the sponsor of 

2 the covered product— 

3 ‘‘(i) in the case of a biological prod4 uct, all data and information available for 

5 public disclosure under section 601.51(e) 

6 of title 21, Code of Federal Regulations (or 

7 successor regulations); and 

8 ‘‘(ii) in the case of another drug, all 

9 data and information available for public 

10 disclosure under section 314.430 of title 

11 21, Code of Federal Regulations (or suc12 cessor regulations). 

13 ‘‘(B) TIMING.—The sponsor of a covered 

14 product shall, with respect to any data or infor15 mation required to be disclosed by subpara16 graph (A), make the disclosure not later than 

17 10 days after the later of— 

18 ‘‘(i) the date on which the Food and 

19 Drug Administration authorizes the emer20 gency use of the covered product under 

21 section 564 of the Federal Food, Drug, 

22 and Cosmetic Act; and 

23 ‘‘(ii) the date on which the data or in24 formation becomes available to the spon25 sor. 


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1 ‘‘(C) EXCEPTIONS.—The disclosure re2 quirement in subparagraph (A) does not apply 

3 with respect to— 

4 ‘‘(i) a trade secret or confidential 

5 commercial or financial information as de6 fined in section 20.61 of title 21, Code of 

7 Federal Regulations (or successor regula8 tions); or 

9 ‘‘(ii) personally identifiable informa10 tion. 

11 ‘‘(3) DISCLOSURE BY HHS.— 

12 ‘‘(A) IN GENERAL.—Subject to subpara13 graph (B), the Secretary shall— 

14 ‘‘(i) not later than 10 days after the 

15 Food and Drug Administration authorizes 

16 the emergency use of a covered product 

17 under section 564 of the Federal Food, 

18 Drug, and Cosmetic Act or approves or li19 censes a covered product under section 505 

20 of such Act or section 351 of this Act, dis21 close to the public, in an easily accessible 

22 location on the website of the Department 

23 of Health and Human Services, all data 

24 and information required by paragraph (2) 


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1 to be disclosed by the sponsor of the prod2 uct; and 

3 ‘‘(ii) not later than 30 days after re4 ceiving any additional such data and infor5 mation, so disclose such data and informa6 tion. 

7 ‘‘(B) EXCEPTION.—The disclosure require8 ment in subparagraph (A) does not apply with 

9 respect to data and information exempted from 

10 disclosure by paragraph (2)(C). 

11 ‘‘(4) ENFORCEMENT AGAINST SPONSORS FOR

12 FAILURE TO DISCLOSE.— 

13 ‘‘(A) EXCLUSION FROM DEFINITION OF

14 ‘COVERED COUNTERMEASURE’.—Notwith15 standing subsection (i)(1), a covered product is 

16 deemed to be excluded from the definition of a 

17 ‘covered countermeasure’ for purposes of the 

18 provisions of this section (other than this sub19 section) and section 319F–4 if— 

20 ‘‘(i) the covered product is adminis21 tered on or after the date of enactment of 

22 the Consumer Vaccine Safety and Protec23 tion Act of 2023; and 

24 ‘‘(ii) the sponsor of the covered prod25 uct is determined by the Secretary to have 


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1 knowingly failed to make a disclosure re2 quired by paragraph (2) with respect to 

3 the covered product. 

4 ‘‘(B) INELIGIBILITY FOR FDA AWARDS, 

5 FUNDS, OR OTHER BENEFITS.—If the sponsor 

6 of a covered product is determined by the Sec7 retary to have knowingly failed to make a dis8 closure required by paragraph (2) with respect 

9 to the covered product, such sponsor shall be 

10 treated as ineligible for the award of any grant, 

11 cooperative agreement, or loan or for any new 

12 grant of emergency use authorization, expanded 

13 access, or approval or licensure of any product 

14 under section 351 of this Act or any provision 

15 of the Federal Food, Drug, and Cosmetic Act 

16 so long as such sponsor continues to be in viola17 tion of such requirement. 

18 ‘‘(5) ENFORCEMENT AGAINST HHS FOR FAIL19 URE TO DISCLOSE.—A party injured by a covered 

20 product with respect to which the Secretary failed to 

21 carry out the Secretary’s duties under paragraph (3) 

22 may bring an action in the appropriate district court 

23 of the United States for appropriate relief, including 

24 damages.’’. 

Æ 


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