FDA threatens drugmaker with fines for failing to report trial results

Regulatory NewsRegulatory News | 28 April 2021 |  By 

Acceleron Pharma became the first drugmaker to face potential fines from the US Food and Drug Administration (FDA) for failing to report clinical trial results to ClinicalTrials.gov.
In a notice of noncompliance sent to Acceleron on 27 April, FDA notified the Cambridge, MA-based drugmaker that it has 30 days to correct the issue or face up to $10,000 per day in civil monetary penalties or other regulatory action including injunction or criminal prosecution.
Matt Fearer, senior director, corporate communication at Acceleron, told Focus that the company is in receipt of the notice from FDA and plans to comply with the agency’s request. “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,” Fearer said.
FDA and the National Institutes of Health (NIH) have faced criticism that they are too lax in enforcing clinical trial reporting requirements established under Section 801 of the Food and Drug Administration Amendments Act of 2007 and later put into effect by a 2016 final rule. Several studies have also highlighted noncompliance with reporting requirements, before and after the final rule took effect in 2017.
In August 2020, two years after issuing a draft version, FDA finalized its guidance on levying penalties on entities that fail to comply with requirements related to clinical trial registration, results reporting or certification submission. Under the policy laid out in the guidance, FDA said it will first send out a pre-notice of noncompliance giving the responsible parties 30 calendar days to voluntarily correct any potential violations, before sending a final notice allowing another 30 calendar days to remedy the situation before the agency levies any penalties.
The notice of noncompliance to Acceleron marks the first time the agency has exercised its new penalty policy. According to the letter, FDA sent a pre-notice to Acceleron in July notifying the company of its potential noncompliance with reporting requirements for a Phase 2 clinical trial of dalantercept plus axitinib in patients with advanced renal cell carcinoma. While the company has published results for the study, which did not achieve its primary endpoint, in the journal Cancer, it has yet to post results for the trial to ClinicalTrials.gov.
“FDA is notifying you that your company is not in compliance with FDAAA’s results information submission requirements, which include the requirements in 42 CFR part 11, and is providing your company with the opportunity to remedy its noncompliance by submitting the required clinical trial results information within 30 calendar days,” FDA wrote in the notice.
In addition to the notice sent to Acceleron, FDA said it has sent more than 40 pre-notices to responsible parties so far but did not elaborate on whether the recipients of those notices have taken steps to comply.
“Being transparent about the results of completed clinical trials enables important advances in the development of medical products and helps ensure a safe, effective and efficient clinical research enterprise,” said Acting FDA Commissioner Janet Woodcock.
Aaron Kesselheim, director of the Program on Regulation, Therapeutics and Law at Brigham and Women’s Hospital, told Focus FDA’s action is a step in the right direction. “Public reporting of clinical trials is extremely important for public health reasons and ethically because it recognizes the sacrifices of the patients who volunteered in the trial. It’s great to see the FDA taking steps to make sure current rules are enforced,” he said.
In an email to Focus, Joseph Ross, professor of medicine and health policy at the Yale School of Medicine, said he hopes the notice to Acceleron is a sign that FDA will begin enforcing clinical trial reporting requirements more strictly. “[FDAAA] was enacted in 2007 with the intention that requiring clinical trial sponsors to register and report their results will improve public health and clinical care by ensuring that all clinical studies are publicly available, so that the results of these studies can inform treatment guidelines and recommendation statements. More than a decade later, FDA is finally taking on its critical role fostering greater transparency into the clinical research enterprise,” Ross said.
FDA, Letter


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