FDA sends 2nd noncompliance notice for company failing to post trial results as crackdown ramps up

30 Jul 2021
endpts.com
The FDA is slowly but surely continuing its crackdown on drugmakers that fail to post their clinical trial results to a government database in a timely manner, this week going after Georgia-based Accuitis, which develops new treatments for skin disorders. Although the agency has previously outlined how it may take enforcement action and assess $10,000 per day fines against companies that fail to report their results, the agency has only sent two letters of noncompliance so far, and no fines have been issued to date. According to a FDAAA tracker from the University of Oxford, the government could have collected more than $21 billion in fines already because of the number of trial results that have not been reported in a timely manner. In the most recent letter of noncompliance from this week, FDA pointed to Accuitis’ failure to post results for a Phase II trial in 36 participants from 2017 for the firm’s experimental treatment for moderate to severe acne rosacea. The company did not respond to a request for comment. Despite sending a prior letter to Accuitis in October 2020, the FDA said it also did not receive a response and said the company is not in compliance with the Food and Drug Administration Amendments Act of 2007’s results information submission requirements, which stipulate that trial results must be sent to the ClinicalTrials.gov databank no later than one year after the primary completion date of the applicable clinical trial. Back in April, FDA also sent a notice of noncompliance to Acceleron Pharma for its failure to post results from a cancer trial. The company posted the results in May. The trial in question flopped back in 2017 and the Cambridge, MA-based biotech halted its development of the drug at the time.
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