Drug marketing felonies lead FDA prosecutions

Share this article:
"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.

Share this article:

Email Newsletters

More in News

Doctors want to know how CMS plans to display Sunshine payment data

Doctors want to know how CMS plans to ...

Physician and industry trade groups are asking CMS to explain how context will be provided to the general public around the dollar sums drugmakers ascribe to doctors for things like ...

Pfizer Q2 sales slip, but still beat expectations

Pfizer Q2 sales slip, but still beat expectations

Patent losses and lost co-promotion agreements put a dent in sales.

Lack of marketing partner delays Afrezza launch

Lack of marketing partner delays Afrezza launch

Afrezza was heralded as one of the most innovative diabetes products of the last decade. So, why hasn't MannKind set a firm launch date for the product?