The Food and Drug Administration (FDA) has issued the final guidance titled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank.”  The guidance is intended for responsible parties, submitters of certain applications and submissions to FDA, and FDA staff.

This guidance document describes the current thinking of FDA regarding civil money penalties under section 303(f)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).   That section authorizes FDA to assess civil money penalties against responsible parties and/or submitters of certain applications and submissions to FDA regarding drug products, biological products, and device products (hereafter, “submitters”) who violate applicable FD&C Act prohibitions relating to requirements under section 402(j) of the Public Health Service Act (PHS Act),¹ including its implementing regulations in 42 CFR part 11, to submit registration and/or results information to the ClinicalTrials.gov data bank and/or certain certifications to FDA.

The guidance document addresses the following questions:

•     How do the Centers intend to identify whether responsible parties have failed to submit required clinical trial registration and/or results information to the ClinicalTrials.gov data bank or submitted false or misleading information to the data bank, or whether submitters have failed to submit to FDA the certification required by section 402(j)(5)(B)² of the PHS Act  or knowingly submitted a false certification to FDA?

•     Under what circumstances may a Center decide to seek civil money penalties against a responsible party or submitter?

•     What procedures apply when a Center seeks civil money penalties?

•     What civil money penalty amounts may be assessed for (1) failing to submit required clinical trial registration and/or results information to the ClinicalTrials.gov data bank, (2) submitting false or misleading information to the data bank, (3) failing to submit the required certification to FDA, or (4) knowingly submitting a false certification to FDA?

This guidance is now available on FDA’s website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/civil-money-penalties-relating-clinicaltrialsgov-data-bank

¹ 42 U.S.C. 282(j)

² 42 U.S.C. 282(j)(5)(B)