Sponsors ignoring FDA requirements will now face stricter penalties.
In an unusual move, FDA is threatening enforcement action against a clinical trial sponsor that has ignored requirements to post study results on the ClinicalTrials.gov website. A letter sent April 27, 2021 warns Acceleron Pharma that it faces a $10,000 penalty if it continues to ignore requirements to disclose summary results information related to a study done years ago for a combination cancer treatment.
The FDA notice marks the first time the agency has publicly threatened fines and possible criminal prosecution for such a violation since the clinical trial disclosure rule went into effect in 2017. FDA issued guidance in August 2020 on how sponsors should meet the disclosure requirements and what action it will take with entities that fail to comply. The guidance explains that FDA will first send the sponsor a pre-notice of noncompliance, which allows 30 days for voluntary action. That would be followed by a final notice allowing another 30 days before levying penalties, as has occurred now with Acceleron. Although the company has published articles on this Phase II study of dalantercept with axitinib for patients with advanced renal cell carcinoma, which turned out to be unsuccessful, the company failed to post results on the CT.gov website managed by the National Library of Medicine at the National Institutes of Health (NIH).
FDA emphasizes that it encourages voluntary compliance with requirements for registering clinical trials for drugs, biological products, and medical devices on the CT.gov website and for submitting required summary results to the clinical trials data bank no later than one year after study completion date. To enforce this policy, FDA now has sent more than 40 pre-notices of noncompliance as part of the agency’s effort to promote greater transparency related to clinical trials and to allow the broader scientific community to access and build on the submitted data. The overarching goal is to enhance public support and participation in the clinical research process.
While continuing to urge sponsors to meet the disclosure policy voluntarily, acting commissioner Janet Woodcock stated that FDA takes enforcement of the clinical trials registration and results information requirement “extremely seriously.” FDA will take “appropriate actions,” Woodcock said, to ensure that required information in available “for the benefit of clinical trial participants and public health.”
Advocates for greater transparency in clinical research applauded FDA’s action, but still harped that it was too slow in enforcing penalties for delayed disclosure, which some analysts regard as widespread among researchers. Sponsors have appeared most reluctant to post study outcomes data for failed clinical trials, as was the case for the Acceleron therapy, partly to avoid acknowledging research disappointments.