Data Transparency and Drug Safety Act of 2022
Bill: H.R.6431 | Sponsor: Rep. Schrier, Kim (D-WA)
Policy area: Health

Summary:
Data Transparency and Drug Safety Act of 2022
This bill makes it a prohibited act under the Federal Food, Drug, and Cosmetic Act to destroy or falsify certain records pertaining to drugs regulated by the Food and Drug Administration (FDA).
Specifically, the bill prohibits falsifying, destroying, omitting. or removing records or information that (1) must be produced during the development or manufacture of a drug, (2) must be produced in an application for FDA approval for a drug or maintained after a drug is approved, or (3) is subject to FDA inspection.
A person (entity or individual) that violates this provision shall be subject to civil monetary penalties. The bill also provides for additional monetary penalties in instances where the violation is not sufficiently remedied after the responsible person has received written notice from the FDA of the violation.

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.

    Be it enacted by the Senate and House of Representatives 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''.

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 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.''.
    (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
                    ``(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.''.
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