FDA Issues Final Guidance on Civil Money Penalties for ClinicalTrials.gov Reporting Violations

J.W. Schomisch
August 17, 2020 at 11:03 AM EST
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The FDA released final guidance Aug. 14 on how the FDA Centers will identify whether responsible parties failed to submit required clinical trial registration and/or results information to the ClinicalTrials.gov data bank or submitted false or misleading information and whether submitters failed to submit the required certification or knowingly submitted a false certification to the FDA.

The final guidance, which is little changed from the September 2018 draft guidance, also addresses the circumstances under which a Center may decide to seek civil money penalties against a responsible party or submitter and addresses the procedures that apply when a Center seeks civil money penalties.

The guidance also addresses the civil money penalty amounts that may be assessed for: failing to submit required clinical trial registration and/or results information to the ClinicalTrials.gov data bank; knowingly submitting false or misleading clinical trial information to the data bank; failing to submit the required certification to the FDA; or knowingly submitting a false certification to the FDA.

“Innovative advances in medical products and transparency in the clinical trials process depend on compliance with ClinicalTrials.gov submission requirements. Certain clinical trials must be registered, and summary results information for such clinical trials must, generally, be submitted within one year of the trial’s primary completion date,” FDA Deputy Commissioner for Medical and Scientific Affairs Anand Shah said in announcing the new guidance. “We expect the regulated community to comply with clinical trial requirements and regulations.”
The final guidance adds a definition of “submitter,” saying a submitter “means the individual or entity that submits certain applications and submissions to FDA regarding drug products, biological products, and device products and who provides a certification to FDA under section 402(j)(5)(B) of the PHS Act. In some cases, the submitter may be someone other than the responsible party for an applicable clinical trial identified in the certification.”

The final guidance also clarifies that the Centers “may also identify violations based on the evaluation of complaints received by the agency. The Centers intend to handle complaints in accordance with their existing processes for handling complaints about potential violations of FDA requirements. In evaluating complaints, the Centers may review any public and non-public information available to FDA, including, but not limited to, information submitted to the ClinicalTrials.gov data bank and to FDA.”

The new guidance also adds examples of responsible parties who have failed to submit required clinical trial registration and/or results information. The guidance said “examples may include, but are not limited to, applicable clinical trials of a drug product, biological product, or device product that has not previously been approved, licensed, or cleared by FDA and is intended to treat a serious and/or life-threatening disease or condition and applicable clinical trials involving vulnerable populations (such as pediatrics), rare diseases, or emergency research conducted without informed consent under 21 C.F.R. §50.24.”

In discussing applicable clinical trials for which noncompliance of the ClinicalTrials.gov rules “exists in conjunction with noncompliance of other statutory and/or regulatory requirements, the new guidance adds the example of “failure to retain clinical trials records or failure to obtain informed consent.”

The final guidance also states that Pre-Notice Letters, which will be sent out when alleged violations are found, “will include an FDA contact to whom a response may be submitted and who can address any questions or concerns of the responsible party/submitter.”

The FDA added it also “intends to post the Notice of Noncompliance on the agency’s website and to transmit the Notice of Noncompliance to the National Institutes of Health so it can include the notice regarding noncompliance in the ClinicalTrials.gov data bank.

Finally, the new guidance said that “in determining whether to seek civil money penalties, FDA intends to take into consideration any corrective action taken by a responsible party or submitter after receiving a Notice of Noncompliance.”

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