Fourteen years after Congress authorized the FDA to take action over clinical trial sponsors’ failure to report applicable trial results on ClinicalTrials.gov, the agency has issued its first notice of noncompliance.

The FDA sent an April 27 notice to Acceleron Pharma, Inc. over its failure to submit results for a Phase 2 randomized, double-blind study of Dalantercept and Axitinib compared to placebo and Axitinib in patients with advanced renal cell carcinoma.

In addition, in July the agency sent a notice to Accuitis, Inc. over its failure to submit results for a trial on the Efficacy of ACU-D1 in the Treatment of Acne Rosacea.

Although the Food and Drug Administration Amendments Act of 2007 (FDAAA) required “responsible parties” to submit clinical trial registration and results information to ClinicalTrials.gov for “applicable clinical trials,” the National Institutes of Health did not publish a final rule for clinical trials registration and results information submission until September 2016 with a compliance date of April 18, 2017.

FDA issued its final guidance on civil money penalties for ClinicalTrials.gov reporting violations in August 2020.

In announcing the notice to Acceleron, FDA’s Acting Commissioner Janet Woodcock noted that the agency has sent more than 40 pre-notices of noncompliance “to encourage voluntary compliance with the ClinicalTrials.gov requirements.”

A July 2020 pre-notice letter to Acceleron requested the company review its records for the clinical trial and submit all required results information promptly. The letter added the FDA “intended to further review and assess this clinical trial beginning 30 calendar days” after Acceleron received the letter and that the agency “might take regulatory action if we determined that your company was not in compliance at that time.”

A similar pre-notice letter was sent to Accuitis in October 2020.

The notices to both companies the FDA said the agency had determined the companies had “failed to submit results information for the applicable clinical trial” and were not in compliance with FDAAA's results information submission requirements.

The agency gave the companies 30 days after receipt of the notice to remedy the noncompliance by submitting the required clinical trial results information. The notice added the FDA “may initiate an administrative action seeking a civil monetary penalty” against the company “of not more than $10,000 for all violations adjudicated in a single proceeding. If your company does not submit the required clinical trial results information in the manner and format specified … within 30 calendar days after receiving this notice, FDA may also seek additional civil monetary penalties … of not more than $10,000 for each day of the violation until the violation is corrected.”

The notice added that the violations also could result in other regulatory action, such as injunction and/or criminal prosecution.

The notice also requested the companies submit a written response to the agency within 30 calendar days after receiving the notice, stating the actions the company took in response to the notice.

“The FDA takes its role in enforcing the ClinicalTrials.gov registration and results information submission requirements extremely seriously and we will continue to encourage voluntary compliance with these requirements,” Woodcock said. “When necessary, the FDA will take appropriate actions to help ensure that required information is available on ClinicalTrials.gov as required by law and for the benefit of clinical trial participants and public health.”

Woodcock added that “NIH will continue to update the ClinicalTrials.gov records for applicable clinical trials that are the subject of a notice of noncompliance with information regarding whether the noncompliance has been corrected and the amount of civil money penalties assessed, if any.”

“Being transparent about the results of completed clinical trials enables important advances in the development of medical products and helps ensure a safe, effective and efficient clinical research enterprise,” Woodcock added.

“These statutory and regulatory requirements are intended to provide greater transparency regarding clinical trials, ultimately allowing the broader scientific community to build on the information submitted,” Woodcock said. “The submission to and posting of clinical trial information on ClinicalTrials.gov honors volunteers who participate in research to advance medical science and enhances public trust by creating a transparent and robust public record of clinical trials and information about their results.”