Brandon May, BioSpace
For the first time, the U.S. Food and Drug Administration (FDA) has sent a notice of noncompliance to Acceleron Pharma, charging the company with failure to post a summary of study data on its cancer combo dalantercept and axitinib in the ClinicalTrials.gov online database. The agency is threatening Acceleron with a $10,000 fine or criminal prosecution if it doesn’t post these results on the website within 30 days.
Federal law mandates companies post a summary of their study results on the government trials website within one year of the study being completed. The FDA previously described its approach in August 2020, outlining how it identifies companies that had failed to submit their trial registration and or summary results to the online clinical trials databank. Since the mandate went into effect, the FDA has sent over 40 pre-notices of noncompliance, mainly verbal warnings.
But the new notice of noncompliance is the first sent by the agency to a pharmaceutical company that threatens prosecution for not posting a summary of study results. “This is historic,” said former Commissioner of the FDA, Robert Califf, MD, in a tweet on Wednesday. “To my knowledge, FDA’s first notice of noncompliance with http://clinicaltrials.gov.”
The study in question involves Acceleron Pharma’s defunct cancer candidate dalantercept combined with axitinib in patients with renal cell carcinoma. The company’s now-defunct cancer candidate flopped in clinical trials, leading Acceleron Pharma to ditch the drug prior to the noncompliance letter.
But because the pharmaceutical company has not released the summary result of these studies on the ClinicalTrials.gov website, it is now facing a $10,000 fine unless it can post the findings within the next 30 days. And if Acceleron Pharma doesn’t comply within the 30-day window, the FDA will seek additional monetary penalties and consider criminal litigation.
“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 the agency’s letter. “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.”
Some believe the FDA has taken too long and has been too light-handed in issuing fines against pharma companies that have failed to post trial results. In 2017, a former official with the FDA filed a lawsuit against the agency that charged the FDA and the National Institutes of Health with failure to follow the established law for reporting clinical trial data.
A trials tracker put into effect in 2018 suggests the FDA could have charged and brought in over $19 billion in fines from companies who have not published a summary of their trial results on ClinicalTrials.gov. So far, no penalties have yet been claimed by the U.S. government, despite the tracker showing only 72% of trials have been reported after January 2018.
This new letter of noncompliance to Acceleron Pharma may represent a turning point for the agency and may send a message to other pharma companies that fail to comply with the clinical trial requirements.