I 

117TH CONGRESS 

2D SESSION H. R. 6431 

To amend the Federal Food, Drug, and Cosmetic Act to prohibit the alteration, falsification, fabrication, destruction, omission, or removal of 

records or certain information required to be produced or maintained 

for a drug, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JANUARY 19, 2022 

Ms. SCHRIER (for herself and Mr. JOYCE of Pennsylvania) introduced the 

following bill; which was referred to the Committee on Energy and Commerce 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

prohibit the alteration, falsification, fabrication, destruction, omission, or removal of records or certain information required to be produced or maintained for a drug, 

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 ‘‘Data Transparency 

5 and Drug Safety Act of 2022’’. 


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•HR 6431 IH

1 SEC. 2. ENHANCED PENALTIES FOR FALSE INFORMATION 

2 AND RECORDS DESTRUCTION. 

3 (a) PROHIBITION OF FALSE INFORMATION AND

4 RECORD DESTRUCTION.—Section 301 of the Federal 

5 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend6 ed by adding at the end the following: 

7 ‘‘(fff) The alteration, falsification, fabrication, de8 struction, omission, or removal of the whole or any part 

9 of records or information that is— 

10 ‘‘(1) required under this Act— 

11 ‘‘(A) to be produced during the develop12 ment or manufacture of a drug; or 

13 ‘‘(B) to be produced or maintained by the 

14 sponsor of an application for the approval of a 

15 drug under section 505 or the holder of an ap16 proved application for a drug under section 

17 505; or 

18 ‘‘(2) subject to inspection under this Act by the 

19 Secretary.’’. 

20 (b) PENALTIES.—Section 303 of the Federal Food, 

21 Drug, and Cosmetic Act (21 U.S.C. 333) is amended by 

22 adding at the end the following: 

23 ‘‘(h) Notwithstanding subsection (a), any person who 

24 violates section 301(fff) shall be subject to— 

25 ‘‘(1) a civil monetary penalty not to exceed— 

26 ‘‘(A) $1,000,000 per violation; and 


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•HR 6431 IH

1 ‘‘(B) $10,000,000 for all violations (ex2 cluding those described in paragraph (2)) adju3 dicated in a single proceeding; and 

4 ‘‘(2) in the case of a violation that continues 

5 after the Secretary provides written notice to such 

6 person, if such person does not sufficiently remedy 

7 the violation including by producing corrected 

8 records or information, additional civil penalties not 

9 to exceed— 

10 ‘‘(A) $1,000,000 for the first 30-day pe11 riod (or any portion thereof) following such no12 tice during which such person continues to be 

13 in violation; 

14 ‘‘(B) for each such 30-day period there15 after, the amount that is double the amount ac16 tually imposed for the preceding 30-day period, 

17 not to exceed $2,000,000 for any 30-day period; 

18 and 

19 ‘‘(C) $20,000,000 for all violations de20 scribed in this paragraph adjudicated in a sin21 gle proceeding.’’. 

Æ 


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