Off-Label Drug promotions are not likely to be caught by the FDA

A new government study performed by the Government Accountability Office, detailed here at FDA News, states that if a company has off-label drug violations, they are unlikely to be caught by the FDA. The FDA issued 42 letters to companies between 2003 and 2007, but none of these cases reached the Justice Department. The eleven cases that were settled by the Justice Department were brought to the court by someone other than the FDA.

The article concludes by saying that the FDA doesn’t have an organized system that makes the FDA’s system unlikely to find off-label violations.