Publication of Clinical Trial Results - FDA Takes Action Against Biopharma Company

Jun 09, 2021

The United States Food and Drug Administration (FDA) issued a Notice of Noncompliance to biopharmaceutical company Acceleron Pharma. The move marks the first time the regulatory agency has made a public threat for non-compliance since the clinical trial disclosure rule was introduced in the US in 2017.

The FDA sent the notice in late April, acting after warning Acceleron in July 2020 that the company had failed to report the study results of its defunct cancer candidate - dalantercept combined with axitinib in patients with renal cell carcinoma, a type of kidney cancer. The trial started in 2012, but Acceleron stopped development of the drug in 2017 after the study failed to reach its primary endpoint.

The letter threatened a $10,000 fine or criminal prosecution if summary data of the trial wasn’t published on the government database, ClinicalTrial.gov, within 30 days. Furthermore, after the 30-day window, the notice stated that penalties could be imposed of up to $10,000 a day until the violation was corrected.

In a statement, a spokesperson for Acceleron said there had been a “clerical oversight.” It has since published the results of the trial on the national database.

A New Era of Enforcement

This latest action by the FDA could be part of a wider shift towards a new global era of enforcement for clinical trial data reporting.

In a statement about its notice against Acceleron, the FDA said: “The submission to and posting of clinical trial information on ClinicalTrials.gov 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”, adding that if the legal requirements are “not met” the agency has the right to “take enforcement action.”

And on May 7, the World Health Organization (WHO) and the International Coalition of Regulatory Authorities (ICRA) issued a strongly worded statement calling on the pharmaceutical industry to provide wider access to data for public health interest for all new medicines and vaccines and to publish results without redaction.

The statement said that the pandemic has “brought into sharp focus” the need for data to support the wider industry and “public confidence in the vaccines and therapeutics being deployed.”

In the US, some believe that the FDA has taken too long to issue fines against sponsors failing to post trial results. In 2018, a former official with the FDA filed a lawsuit, charging the FDA and National Institutes of Health (NIH) with failure to follow the law for clinical trial data reporting. And a total of $19 billion since 2018 could have been collected in fines, according to a tracking site at the University of Oxford.

However, the recent action taken against Acceleron Pharma could represent a turning point for the FDA, sending a stern message to other sponsors that fail to comply with the clinical trial disclosure requirements.

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