“Prior to 1990, most prosecutions for violations of the Federal Food, Drug, and Cosmetic Act (FDCA), were for misdemeanors; since, the most common charges brought against drug companies by the US Department of Justice (DOJ) have been for felonies.” So said DOJ consumer litigation director Eugene Thirolf, at a Food and Drug Law Institute Conference on Advertising and Promotion.
He indicated that advertising and marketing of drugs and medical devices represent the most frequent subjects of criminal investigation. He said the rise in criminal cases is related to the fact that federal Medicare/Medicaid programs are paying for a larger percentage of the costs.
Another important “driver” is related to increased reports by “whistle blowers,” or qui tam cases brought under the False Claims Act, Thirolf said.
The HHS reported that whistleblowers filing these suits were awarded $136,756,946 in 2005, up significantly from the $82,867,287 in 2004.
From the November 01, 2006 Issue of MM+M - Medical Marketing and Media
