May 3, 2021 – Although the Food and Drug Administration (FDA) has issued more than 40 “Pre-Notices of Noncompliance” to companies to encourage voluntarily compliance with a federal requirement to submit all clinical trial data to the ClinicalTrials.gov database, last week the agency issued its first “Notice of Noncompliance” to Acceleron Pharma for not complying with this requirement. In the April 27 notice, the agency gives Acceleron 30 days to comply or face civil money penalties of up to $10,000.
Transparency in clinical trials has been a hot-button issue in the United States and around the globe, and several industry critics have warned that the FDA’s lack of enforcement of this requirement – established by the FDA Amendments Act of 2007 (FDAAA) – has rendered it toothless. Perhaps the agency’s first Notice of Noncompliance is a move in the right direction.
“This is an important step, indicating that the FDA intends to more actively enforce compliance,” said Coalition for Healthcare Communication Executive Director Jon Bigelow. “Making information from all clinical trials – even those showing negative or inconclusive results and those involving products that may never proceed to an NDA or FDA approval – available on the ClinicalTrials.gov site is important to help other investigators confirm results and to learn from past studies as they design further trials or consider different therapeutic strategies. It also enhances public trust in the integrity of pharmaceutical research.”
Acting FDA Commissioner Janet Woodcock, M.D., underscored that point in an April 28 statement, saying that “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 federal requirement mandates that clinical trial sponsors register applicable clinical trials on ClinicalTrials.gov within 21 days after the first human subject is enrolled and submit summary results information for those trials no later than one year after the study’s completion date, unless a deadline extension is granted.
“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,” according to Woodcock. “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.”
However, despite that assertion, the FDA has not exercised its enforcement authority to ensure compliance beyond fostering voluntary action until now, even though the website FDAAA Trials Tracker reports that only 72.3 percent of clinical trials are reported.
In this case, Acceleron received a pre-notice letter on July 20, 2020, about its lack of compliance with the ClinicalTrials.gov submission requirement in relation to a Phase 2 clinical trial that evaluated the safety and effectiveness of the drug dalantercept in combination with axitinib in patients with advanced renal cell carcinoma. Nine months later, the Notice of Noncompliance was issued. Acceleron has until May 27 to comply with the requirement.