Partner David Rosen was quoted in a Modern Healthcare
article, “New Safety Threats Identified in One-Third of Drugs Post-Approval
,” covering why these statistics make sense, and covering FDA user fees as they relate to the issue.
Rosen explained he doesn’t think “the user fee time deadlines really have an impact [on the issue]; it doesn’t mean that the FDA is putting out drugs that are less safe. The FDA takes safety very seriously and does the best job it can in making sure labels show the proper risk and benefits and are updated.”