- The Food and Drug Administration has issued its first notice of noncompliance to a company for failing to submit details of a study to a federal database, citing biotech company Acceleron Pharma.
- The agency said it acted after warning the company in July that it had failed to properly report the results of a study of the drug dalantercept in patients with kidney cancer. The FDA said Acceleron has 30 days to act before facing penalties, including civil fines.
- In a statement, Acceleron spokesman Matt Fearer blamed a clerical oversight for the company's lack of compliance and said the study results will be posted within 30 days. Acceleron stopped development of dalantercept in 2017 after the trial in question failed to reach its primary endpoint, and the company immediately notified the FDA at the time, he said.
The FDA's action is significant if it's a sign of a larger crackdown. More than a quarter of clinical trials aren't properly reported, and the U.S. government could have imposed billions of dollars in fines as a result, according to a tracking website developed by the University of Oxford.
The idea behind the federal database clinicaltrials.gov is to give patients and researchers as much information as possible on experimental medicines. Congress first passed a law requiring study registration in 1997, then in 2007 expanded the requirements and included the potential for penalties for noncompliance. Comment and rulemaking processes followed, and the Health and Human Services Department issued a final rule that became effective in 2017.
Until now, the FDA has done relatively little to enforce the requirement. In its news release on Acceleron, the agency said it has sent more than 40 "pre-notices" of noncompliance.
Although Acceleron did not file the results of the study on ClinicalTrials.gov, the company did publish the results in 2019 in the journal Cancer, which also appeared on the National Library of Medicine website. The National Library of Medicine maintains the ClinicalTrials.gov website.
"The company believes in full transparency and data disclosure," Fearer said in an emailed response to a request for comment. Acceleron also "places the utmost importance on meeting its obligations to the FDA and all other regulatory authorities," he said.
Companies in general have a better track record on ClinicalTrials.gov than academic centers and even the federal government, Science reported last year. The journal looked at more than 4,700 clinical trials, finding that less than 45% reported their results early or on time to the site.