Another drug firm faces potential fines for research non-reporting

Regulatory NewsRegulatory News | 30 July 2021 |  By 

A small Georgia pharmaceutical company has received a notice of noncompliance from the US Food and Drug Administration (FDA) for not registering clinical trial results in a central government registry, as required by federal law.
The 26 July letter is the second issued by FDA for noncompliance with federal research reporting requirements outlined in Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA). If results are not reported within one year after the primary completion date of a clinical trial that falls under these reporting requirements, FDA has the authority to impose civil monetary penalties up to $10,000 per day, or to pursue injunction or even criminal prosecution. FDA finalized guidance outlining its intended course of action in cases of Section 801 violations in August 2020.
This most recent letter, sent to Accuitis, Inc., noted that the firm had not responded to an October 2020 letter from FSA requesting that Accuitis “submit all required results information promptly” for its clinical trial.
The study in question was a randomized, vehicle-controlled, double-blind study of a topical treatment for rosacea, with an estimated enrollment of 36 participants. Though no results are posted to the website, one June 2021 publication has been automatically indexed to the study.
The first noncompliance letter was issued in April 2021 to Acceleron Pharma, which had not responded to earlier communication from the agency. Acceleron responded with alacrity to the April missive from FDA, filing its report of the negative study on within a day of receiving the noncompliance letter. (RELATED: FDA threatens drugmaker with fines for failing to report trial results, Regulatory Focus 28 April 2021; Acceleron, under threat of fines, reports out a negative study, Regulatory Focus 25 May 2021).
At that time, Focus reached out to Nicholas DeVito, a doctoral researcher at the University of Oxford, UK. DeVito, who is part of a research team that looks into research integrity and reporting issues and maintains the FDAAA Trials Tracker, commented that “around 70% of covered trials report results at some point, fewer than 40% are meeting the one-year statutory reporting deadline and this doesn’t appear to be improving.”
However, he said, the Trials Tracker had been seeing “an uptick in reporting” that roughly coincided with the issuance of the Acceleron noncompliance letter, “suggesting the FDA taking this action may have caught the attention of other sponsors with missing results.”
Unlike the Accuitis clinical trial, the study for which Acceleron received a noncompliance notice involved parenteral medication for a potentially life-threatening condition, advanced renal cell carcinoma. In correspondence with FDA, Focus asked why Accuitis, in particular, had received a noncompliance letter, given the relatively small study size and relatively lower risk for patient harm in the rosacea study.
In response, the trade press office for FDA’s Center for Drug Evaluation and Research provided an unattributed statement that the agency “uses a risk-based approach to determine the situations in which Pre-Notices of Noncompliance will be issued, consistent with FDA’s public health mission and how the agency approaches its other compliance programs.”
The response continued, “The vast majority of recipients of pre-notices have taken voluntary action to address the issues of noncompliance. If recipients of pre-notices do not correct the issues of noncompliance, the agency will take appropriate action such as issuing a notice of noncompliance.”
Focus has asked FDA how many trialists have been notified of reporting deficiencies, and for a more precise characterization of the “vast majority” who have corrected reporting issues after receiving a pre-notice letter. This article will be updated with any information received in response.
Accuitis was contacted with an invitation to provide a comment for this article but had not responded by press time.
Accuitis notice of noncompliance letter


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