Under FDA regulations, the “responsible party” or the “submitter” (these are often the same individual or entity) must provide FDA with certain information related to clinical trials for drugs, biologics and medical devices.

In August 2020, the U.S. Food and Drug Administration (FDA) issued guidance on the imposition of civil monetary penalties for violations of clinical trial reporting requirements. The new guidance is welcome insight for members of the pharmaceutical, biologics and medical device industries, particularly in light of the race to develop—and convince FDA of the safety and effectiveness of—COVID-19 vaccines, therapeutics and diagnostic tests.

The new final guidance sheds light on FDA’s Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health’s current views on the monetary penalties for responsible parties and those who submit certain drug-, biologic- and device-related applications and submissions to FDA without certain clinical trial registration and results to the ClinicalTrials.gov data bank and certifications to FDA, as required by federal law.

Under FDA regulations, the “responsible party” or the “submitter” (these are often the same individual or entity) must provide FDA with certain information related to clinical trials for drugs, biologics and medical devices. For instance, certain clinical trial information including clinical trial registration and results information must be submitted to the data bank maintained at ClinicalTrials.gov. And, when a person submits an application or submission related to a drug, biologic or medical device under sections 505, 510(k), 515, and 520(m) of the Federal Food, Drug & Cosmetics Act (FDCA) or section 351 of the Public Health Service Act, the application or submission must be accompanied by a certification (on Form FDA 3674) that all applicable requirements have been met for all applicable clinical trials included in, relied on or otherwise referred to in the given application or submission.

The guidance addresses a number of potential issues associated with violations of the above requirements:

How FDA Centers Will Identify Failure to Provide Required Information or Certification or Provision of False or Misleading Information or False Certification

According to the guidance, the FDA centers intend to identify violations of the requirements relating to the submission of information to the ClinicalTrials.gov data bank by reviewing evidence collected during inspections. The process by which FDA will collect information is contained in guidance on bioresearch monitoring. The FDA centers may also identify violations based on evaluation of complaints received by FDA, which FDA will handle in accordance with the existing process for handling complaints related to violations of FDA requirements. The guidance clarifies that FDA may review any public and nonpublic information available to FDA, including information submitted to ClinicalTrials.gov or to FDA through other means.

When FDA Centers May Decide to Seek Civil Monetary Penalties Against a Responsible Party or Submitter

Generally, once an FDA center believes that there has been a violation of a clinical trial reporting requirement, the center intends to send a Preliminary Notice of Noncompliance letter, describing the potential violation, requiring any necessary corrective action within 30 days, advising that after 30 days of receipt of the preliminary notice, FDA will begin a further review of all available evidence and stating that failure to comply with the requirements concerning clinical trial information reporting may result in further action (these actions include a formal Notice of Noncompliance, civil monetary penalties, an injunction and/or criminal prosecution). If, 30 days after receipt of the preliminary notice, an FDA center determines that the responsible party or submitter has failed to submit the required information or certification (or provided false or misleading information or a false certification), it will issue a Notice of Noncompliance, advising the recipient that it has 30 days to remedy the noncompliance.

In determining whether to seek civil monetary penalties, FDA will take into consideration the corrective action (if any) taken after receipt of the Notice of Noncompliance. If a responsible party or submitter has not remedied the noncompliance, the FDA centers have stated an intent to seek monetary penalties, taking into account the type of noncompliance and the circumstances associated with the failure to remedy the noncompliance.

According to the guidance, under FDA’s risk-based approach, FDA plans to focus its enforcement and regulatory attention on situations in which (i) a person fails to provide accurate information for clinical trials of a product that may pose a higher risk to human subjects or that is intended to address a significant public health need (such as clinical trials for a product that has not been previously approved and that is intended to treat a serious or life-threatening disease or condition or clinical trials involving vulnerable populations); (ii) a person has demonstrated a pattern of previous noncompliance with reporting requirements; and (iii) clinical trial information reporting violations occur alongside violations of other regulatory or statutory requirements related to the conduct of the trial.

Amounts of Civil Monetary Penalties That May Be Assessed

Under the FDCA, civil monetary payments may be assessed for (a) failing to submit required clinical trial registration or results to the data bank; (b) submitting false or misleading data; (c) failing to submit the required certification to FDA; or (d) knowingly submitting a false certification to FDA.

The statutory maximum penalty for each of these prohibited acts, under section 303 of the FDCA, is an amount up to $10,000 for all violations adjudicated in a single proceeding. If a violation is not corrected within 30 days of notification of the violation, FDA may impose additional monetary penalties of up to $10,000 for each day that the violation continues until it is corrected. In determining the amount of civil monetary penalties sought, FDA considers the nature, circumstances, extent and gravity of the violation(s) and, with respect to the violator, ability to pay, effect on ability to continue to do business, any history of prior such violations, the degree of culpability and such other matters as justice may require. 

Conclusion

The final guidance contains additional recommendations and information, including expanded recommendations on the topics discussed above and an overview of the procedures governing the FDA centers’ attempt to seek civil monetary penalties and the responsible party’s or submitter’s opportunity to contest the penalty.

As with all other guidance documents, this guidance does not establish legally enforceable responsibilities or obligations; rather, FDA’s current thinking on the topics discussed should be taken only as recommendations, except where specific regulatory or statutory requirements are cited. 

For More Information

If you have any questions about this Alert, please contact Frederick R. Ball, Sandra G. Stoneman, Justin M. L. Stern, any of the attorneys in our Life Sciences and Medical Technologies Industry Group or the attorney in the firm with whom you are regularly in contact. 

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