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

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 Click here to view original post