I 
117TH CONGRESS 
2D SESSION 
H. R. 6431 
To amend the Federal Food, Drug, and Cosmetic Act to prohibit the alter-
ation, 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, destruc-
tion, omission, or removal of records or certain informa-
tion required to be produced or maintained for a drug, 
and for other purposes. 
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 ‘‘Data Transparency 
and Drug Safety Act of 2022’’. 
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SEC. 2. ENHANCED PENALTIES FOR FALSE INFORMATION 
AND RECORDS DESTRUCTION. 
(a) PROHIBITION
OF FALSE INFORMATION
AND 
RECORD DESTRUCTION.—Section 301 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend-
ed by adding at the end the following: 
‘‘(fff) The alteration, falsification, fabrication, de-
struction, omission, or removal of the whole or any part 
of records or information that is— 
‘‘(1) required under this Act— 
‘‘(A) to be produced during the develop-
ment or manufacture of a drug; or 
‘‘(B) to be produced or maintained by the 
sponsor of an application for the approval of a 
drug under section 505 or the holder of an ap-
proved application for a drug under section 
505; or 
‘‘(2) subject to inspection under this Act by the 
Secretary.’’. 
(b) PENALTIES.—Section 303 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 333) is amended by 
adding at the end the following: 
‘‘(h) Notwithstanding subsection (a), any person who 
violates section 301(fff) shall be subject to— 
‘‘(1) a civil monetary penalty not to exceed— 
‘‘(A) $1,000,000 per violation; and 
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‘‘(B) $10,000,000 for all violations (ex-
cluding those described in paragraph (2)) adju-
dicated in a single proceeding; and 
‘‘(2) in the case of a violation that continues 
after the Secretary provides written notice to such 
person, if such person does not sufficiently remedy 
the violation including by producing corrected 
records or information, additional civil penalties not 
to exceed— 
‘‘(A) $1,000,000 for the first 30-day pe-
riod (or any portion thereof) following such no-
tice during which such person continues to be 
in violation; 
‘‘(B) for each such 30-day period there-
after, the amount that is double the amount ac-
tually imposed for the preceding 30-day period, 
not to exceed $2,000,000 for any 30-day period; 
and 
‘‘(C) $20,000,000 for all violations de-
scribed in this paragraph adjudicated in a sin-
gle proceeding.’’. 
Æ 
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