Regulatory Focus™ > News Articles > 2021 > 5 > Acceleron, under threat of fines, reports out a negative study

Acceleron, under threat of fines, reports out a negative study

Posted 25 May 2021 | By Kari Oakes 

Acceleron, under threat of fines, reports out a negative study

Nicholas DeVito

The day after receiving a first-ever threat of civil penalties for failure to report clinical trial results to ClinicalTrials.gov, Acceleron Pharma fulfilled a legal mandate by posting summary results to the federal trials website.
 
Though the negative results for its trial of dalantercept and axitinib in patients with advanced renal cell carcinoma had been published elsewhere years earlier, Massachusetts-based Acceleron had not previously complied with federal reporting requirements. Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) took effect in 2017, after enactment of a 2016 final rule requiring that investigators provide summary results of certain trial data within one year or face civil penalties of up to $10,000 per day of noncompliance.
 
FDA finalized guidance outlining its intended course of action in cases of Section 801 violations in August 2020; in addition to monetary penalties, the agency may pursue other regulatory actions, to include injunctions and criminal prosecution. The 27 April notice of noncompliance to Acceleron was the first such letter FDA has issued.
 
Nicholas DeVito, a doctoral researcher at the University of Oxford, UK, is part of a research team that investigates clinical trial reporting and other research integrity issues. In an interview with Focus, DeVito said that his team’s ongoing work in their FDAAA TrialsTracker and in a 24 May JAMA Internal Medicine research letter “shows that while around 70% of covered trials report results at some point, fewer than 40% are meeting the one-year statutory reporting deadline and this doesn’t appear to be improving.”
 
“We’ve also consistently shown that academic and other non-commercial sponsors fall behind their industry counterparts when it comes to complying with various aspects of the law,” said DeVito, adding that his group and others “have been calling for stronger enforcement of the FDAAA for years now, and it appears that this letter is showing the impact these efforts can have on transparency.”
 
Focus reached out to Acceleron in April 2021, when the notice of noncompliance was issued. At that time, Matt Fearer, Acceleron’s senior director of corporate communications, responded that “Acceleron places the utmost importance on meeting its obligations to the FDA and all other regulatory authorities. Accordingly, the company will post the trial results on clinicaltrials.gov within the 30-day remediation period set forth by the agency.” (RELATED: FDA threatens drugmaker with fines for failing to report trial results, Regulatory Focus 28 April 2021)
 
Fearer repeated his assertion that Acceleron was taking the situation seriously in an email Wednesday. He pointed to other actions by the firm, noting that “Acceleron notified FDA immediately upon the termination of the trial and of the agent (dalantercept) in 2017, submitted the trial data to FDA, and published the data in the peer-reviewed journal Cancer in 2019.”
 
Fearer characterized the failure to complete the legally mandated reporting as a clerical error. “The failure to post the data on clinicaltrials.gov was a clerical oversight on the company’s part that has now been rectified,” he noted.  
 
Acceleron had not corrected its failure to report in the interval between July 2020, when it received a pre-notice of its potential noncompliance, and the notice of noncompliance that made explicit the risk of monetary penalties or other enforcement actions.
 
Focus also asked FDA’s Center for Drug Evaluation and Research (CDER) for commentary about Acceleron’s posting of data after the noncompliance letter was issued, and before the 30-day deadline.
 
An FDA official responded, in part, “As noted on the public ClinicalTrials.gov record for NCT01727336, Acceleron submitted summary results information for the clinical trial on April 28, 2021. As with all applicable clinical trials for which results information is submitted to ClinicalTrials.gov, NIH conducts a limited quality control review of the clinical trial results information that Acceleron submitted. FDA also will assess the submitted results information to determine whether the noncompliance has been remedied.”
 
DeVito says other firms may be paying attention. “Acceleron went from being years overdue in reporting this trial to ClinicalTrials.gov to having full results on the registry within a few weeks. Within the past month, they also corrected data for another trial that appeared to be overdue — NCT03496207 — when the noncompliance letter was issued,” he said. “We’ve also seen an uptick in reporting over the past few weeks on our FDAAA TrialsTracker, suggesting the FDA taking this action may have caught the attention of other sponsors with missing results.”
 
DeVito also noted that data from the “hundreds of unreported trials” he and others have identified may not ever be published in any form. A downstream effect of the missing data, which are more likely to be negative than positive, may be “potential issues with publication bias in future guideline development and evidence synthesis efforts.”
 
The CDER representative did not respond when asked if the 27 April letter to Acceleron represented the beginning of a new era of increased scrutiny of such failures to report clinical trial results. The agency “uses a risk-based approach to determine the situations in which Pre-Notices of Noncompliance will be issued, consistent with FDA’s public health mission and how the agency approaches its other compliance programs,” according to the official.
 
“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,” added the official.

 

© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe