September 20, 2018
“When clinical trial information is properly submitted to ClinicalTrials.gov, patients can more easily seek access to trials and the scientific community can more easily access information that can inform research. The reliable exchange of this information plays an important role in advancing innovation,” said FDA Commissioner Scott Gottlieb, M.D. “The FDA is responsible for enforcing the clinical trial registration and summary results information submission and certification requirements. Today we’re outlining our current proposal for how we intend to evaluate whether to pursue civil money penalties against those who violate the ClinicalTrials.gov requirements, as a way to make sure that we’re promoting submission of accurate information that patients and providers can confidently rely on.”
The law requires certain clinical trials be registered and their summary results information be submitted to ClinicalTrials.gov, a data bank managed by the National Institutes of Health/National Library of Medicine. The law further requires submitters of certain applications and submissions to the FDA regarding drug products, biological products, and device products to certify that all ClinicalTrials.gov requirements have been met.
Today, the FDA has issued a draft guidance outlining how the FDA’s medical product centers currently intend to identify whether responsible parties have failed to submit required clinical trial registration and/or results information to the ClinicalTrials.gov data bank for clinical trials involving FDA-regulated drug, biological and device products; if they have submitted false or misleading information to the data bank; or if they have failed to submit or knowingly submitted a false certification to the FDA. The draft guidance also clarifies the circumstances under which an FDA medical product center may decide to seek civil money penalties for non-compliance, the applicable procedures for assessing civil money penalties, and the civil money penalty amounts that may be assessed for violations related to the ClinicalTrials.gov requirements.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.