May 7, 2021

FDA Threatens First Firm With Fines for Reporting Failure

After issuing a warning letter nearly a year ago for failure to post required summary trial results on ClinicalTrials.gov, the Food and Drug Administration (FDA) has given Cambridge, Massachusetts-based Acceleron Pharma Inc. a month to submit data from a Phase 2 trial of medications for the treatment of advanced renal cancer or it will face sanctions, including fines. This is the first time FDA has taken action against a firm for noncompliance with reporting requirements. According to FDA’s April 27 letter to Acceleron, FDA alerted the firm in July of “potential noncompliance” and requested it “submit all required results information promptly.”

 

In an April 28 news release, FDA explained that the “Notice of Noncompliance gives Acceleron 30 days to submit the required summary results information. The FDA is authorized to seek civil money penalties for Acceleron’s violation, including additional civil money penalties if Acceleron fails to submit the required information within the 30-day period.” FDA noted that “federal law requires that responsible parties, typically trial sponsors, register applicable clinical trials on ClinicalTrials.gov within 21 days after the first human subject is enrolled and submit certain summary results information for those trials, generally no later than one year after the study’s completion date unless a deadline extension is obtained.” Violations are subject to fines of up to $10,000 per day, in addition to other potential “regulatory action, such as injunction and/ or criminal prosecution.” Compliance with the reporting requirements “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,” FDA said. Acceleron has not publicly responded to the notice.

Link to FDA announcement

Link to Noncompliance Notice