Section 1 Short title
This Act may be cited as the “Data Transparency and Drug Safety Act of 2022”.
Data Transparency and Drug Safety Act of 2022
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.
Sec. 2 Enhanced penalties for false information and records destruction
Prohibition of false information and record destruction— Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the following:
“(fff) The alteration, falsification, fabrication, destruction, 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 development 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 approved application for a drug under section 505; or
“(2) subject to inspection under this Act by the Secretary.”
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
“(B) $10,000,000 for all violations (excluding those described in paragraph (2)) adjudicated 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 period (or any portion thereof) following such notice during which such person continues to be in violation;
“(B) for each such 30-day period thereafter, the amount that is double the amount actually 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 described in this paragraph adjudicated in a single proceeding.”