Acceleron receives FDA Notice of Noncompliance

The US Food and Drug Administration (FDA) has issued its first ever Notice of Noncompliance to Acceleron Pharma Inc. for failing to submit required summary results information to ClinicalTrials.gov. The notice gives Acceleron 30 days to submit the required information or face civil money penalties.

In a strongly worded statement, the FDA reminded stakeholders that federal law requires responsible parties (typically trial sponsors,) to register applicable clinical trials on ClinicalTrials.gov within 21 days of the first human subject being enrolled and submit certain summary results information for those trials, generally no later than a year after the study’s completion date, unless a deadline extension is obtained. It stated, “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.”

The agency determines whether responsible parties are complying with these legal requirements and has the authority to take enforcement action when they are not met.

The regulator has previously outlined its approach to identifying whether responsible parties have failed to submit required registration and/or summary results information to the ClinicalTrials.gov data bank for trials studying drug products, biological products and device products. “Although many responsible parties comply with the law without FDA action, the agency has sent Pre-Notices of Noncompliance (more than 40 to date) to encourage voluntary compliance with the ClinicalTrials.gov requirements,” it stated.

In the case of Acceleron, the FDA said it had determined that the responsible party, who received a Pre-Notice of Noncompliance in June 2020, has not complied with its legal reporting obligations. As such, the agency has issued its first Notice of Noncompliance for failing to submit required summary results information to ClinicalTrials.gov. The applicable trial (NCT01727336) evaluated the safety and effectiveness of dalantercept in combination with axitinib in patients with advanced renal cell carcinoma. The Notice of Noncompliance gives Acceleron 30 days to submit the required summary results information. If the company fails to do this within the 30-day period, the FDA can seek civil money penalties for the violation.

The regulator stated that the Notice of Noncompliance has been posted to the FDA’s website and information about the noncompliance will be posted on the study record on ClinicalTrials.gov by the US National Institutes of Health (NIH). NIH will, it said, continue to update the ClinicalTrials.gov records for the trial that is subject to the Notice of Noncompliance with information regarding whether the noncompliance has been corrected and the amount of civil money penalties assessed, if any.

The FDA concluded its statement with, “the FDA takes its role in enforcing the ClinicalTrials.gov registration and results information submission requirements extremely seriously” adding that though it would continue to encourage voluntary compliance, it would take “appropriate actions” to ensure that information is available on ClinicalTrials.gov as required by law.