The U.S. Food and Drug Administration (FDA) has recently intensified its focus on the submission of clinical trial data, issuing a notice of noncompliance to the FADOI Foundation for failing to report required results on ClinicalTrials.gov. This action signals a potential increase in the agency's enforcement efforts regarding clinical trial data reporting.
The FDA's notice cites a violation of Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) and its implementing regulations under 42 CFR Part 11. These regulations mandate that clinical trial sponsors register applicable trials and submit summary results within one year of the study's primary completion date, unless a timely certification of delay, extension request, or waiver request has been submitted.
The specific clinical trial in question had a primary completion date in December 2019. The FDA sent a letter in September 2023 requesting a review of records and submission of all required trial results. Despite "extensive" correspondence, the results remained unsubmitted.
The FADOI Foundation has been given 30 days from the notice's receipt to submit the required information. Failure to comply could result in civil monetary penalties of up to $10,000 per day.
Implications for Clinical Trial Sponsors
This notice underscores the FDA's heightened scrutiny of compliance with clinical trial information reporting requirements. Sponsors and investigators should familiarize themselves with 42 CFR Part 11 to ensure timely and accurate submission of all required data.
SEC Disclosure and Liability
For public companies, a notice of noncompliance can trigger Securities and Exchange Commission (SEC) disclosure obligations. Companies may need to disclose material regulatory actions in securities filings and could face shareholder liability for inadequate disclosure.
Impact of SEC v. Jarkesy
The FDA's enforcement capabilities may be affected by the Supreme Court's decision in SEC v. Jarkesy, which limits administrative agencies' ability to enforce civil penalties through internal proceedings. This could influence the FDA's approach to pursuing penalties for noncompliance in this and other contexts.
