FDA Announced Draft Guidance: Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank

10/31/2018

Background:

Currently, the “responsible party” must register and provide results of any applicable clinical trial in the ClinicalTrials.gov data bank under the requirements of the Food and Drug Administration Amendments Act (FDAAA) of 2007, which added the provision to the Public Health Service Act. Submitting false or misleading information, failing to register, or failing to provide results for applicable clinical trials is prohibited by an FDAAA amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Also, FDAAA amended 303(f)(3) of the FD&C Act to allow for assessment of civil money penalties for responsible parties who violated these provisions. This is relevant for drug, device, and biologic products.

Key questions that will be addressed by the guidance when finalized:

  • Which factors are considered for determining if the responsible party 1) submitted false or misleading information, 2) failed to register, or 3) failed to submit results for applicable clinical trials.

  • When the appropriate FDA Center can seek civil financial penalties.

  • What the process is for the appropriate FDA Center to seek civil financial penalties.

  • How much money the appropriate FDA Center may seek for different violations of the ClinicalTrials.gov registration and results data requirement.

The comment period for the draft guidance is open through November 20, 2018. Comments can be submitted here, and the draft guidance can be found here.

 

- The Clinical Pathways Team 

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