The US Food and Drug Administration (FDA) recently issued a notice of noncompliance to the FADOI Foundation, citing the organization’s failure to submit required clinical trial results to ClinicalTrials.gov. The notice reflects FDA’s increasing attention toward noncompliance with the agency’s requirements for submission of clinical trials information and may signal an increase in enforcement that we may see from FDA going forward.
The most recent notice cited the failure to submit results for the trial as required under Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) and FDA’s implementing regulations under 42 CFR Part 11. FDA regulations require responsible parties, most often clinical trial sponsors, to register applicable clinical trials and submit summary results of such trials within one year after the study’s primary completion date, unless the responsible party has submitted (1) a timely certification of delay, (2) a request for an extension for good cause, or (3) a request for waiver of the requirements to submit results information.
The clinical trial at issue had a primary study completion date in December 2019. FDA’s notice states FDA sent a letter in September 2023 requesting that the organization review its records and submit all required trial results information. Further, FDA stated in the notice that the agency intended to further review and assess the trial beginning 30 days after the organization’s receipt of the September 2023 letter. The notice also states that despite “extensive” correspondence between the agency and the organization after receipt of the letter, results information has not been submitted.
FDA stated in the most recent notice that the organization will have 30 days from the receipt of the notice to submit the required clinical trials results information. If the information is not provided in a timely manner, FDA noted the agency may seek civil monetary penalties against the organization, which can reach up to $10,000 per day for continued noncompliance.
Key Considerations
The recent notice raises several key considerations for clinical trial sponsors and other responsible persons for clinical trials operations. First, FDA’s notice of noncompliance signifies continued increased attention by the agency to noncompliance with requirements to submit clinical trials information. FDA has issued several similar notices in the last five years. Given the increased attention, sponsors and investigators should familiarize themselves with the regulatory requirements under 42 CFR Part 11 to ensure timely submission of required clinical trial information and compliance with the regulatory requirements.
Second, the notice of noncompliance raises potential Securities and Exchange Commission (SEC) disclosure and liability implications for companies in the United States. Public companies operating clinical trials may be required to include in securities filings disclosures regarding material regulatory actions, which may include notices of noncompliance. Moreover, companies may be exposed to shareholder liability for failure to adequately disclose this information in public filings.
Lastly, FDA issued the notice of noncompliance after the US Supreme Court’s recent decision in SEC v. Jarkesy, a case with broader implications for the ability of administrative agencies to use internal administrative procedures to enforce civil penalties. The Jarkesy decision focused on the SEC’s authority to enforce civil penalties through the agency’s internal administrative proceedings. The decision held that such penalties must be enforced through federal court, rather than in proceedings before an Administrative Law Judge (ALJ). Following suit, going forward, FDA may be similarly limited in its ability to seek such penalties through internal administrative proceedings, which may in turn impact FDA’s willingness to carryout out actions for such penalties in this and potentially other contexts, despite its indication to the contrary in its recent notice.
Conclusion
The notice of noncompliance reflects increased attention by FDA on compliance with, and enforcement of, information reporting requirements for clinical trials. Sponsors should work to ensure timely and adequate submission of all required information in compliance with the regulations in 42 CFR Part 11.