FDA Notice Threatens Second Sponsor with Heavy Fines for Failure to Report Results
The FDA has warned a second company of possible enforcement action for failing to report trial results, giving the drugmaker a deadline of Aug. 25 to post results of a 2018 phase 2 trial. To date, the company — Alpharetta, Ga.-based Accuitis — has made no visible move to comply with agency requirements to submit trial results to ClinicalTrials.gov.
According to a July 26 FDA noncompliance letter, Accuitis didn’t submit results from a 36-participant phase 2 trial of its acne rosacea drug candidate, despite prior prompting from the agency in October 2020.
Unlike the first recipient of a noncompliance letter, Acceleron Pharma, which submitted its missing summary results information within a day of receiving the agency’s first noncompliance letter in April, Accuitis hasn’t responded to media inquiries and does not appear to have publicly acknowledged the issue.
If the company fails to meet the Aug. 25 deadline, it faces up to $13,000 in fines per day until the results are posted and could even be hit with an injunction or criminal prosecution, according to the FDA.
A trials tracker run by the University of Oxford has determined that 2,775 of 10,980 trials (26.1 percent) required by the FDA to post results still haven’t done so. The university calculated that the agency could have imposed $22.5 billion in fines as a result of the noncompliance, yet according to the tracker, not a single dollar in fines has yet been claimed by the government.
The FDA has sent preliminary notices of noncompliance to more than 60 additional sponsors in the past year, indicating that dozens of companies could soon find themselves facing noncompliance letters. The agency, however, has declined to comment on its future enforcement plans.
Read the Accuitis noncompliance letter here: https://bit.ly/37xtzlI.