Criminal Charges for Off Label Marketing

A New Jersey sales manager pled guilty to a one count information charging her with distribution of a misbranded drug, Bextra. Mary Holloway faces up to six months in prison and up to $100,000 in fines or twice the amount of the gross gain or gross loss.

The FDA approved Bextra for osteoarthritis, adult rheumatoid arthritis, and primary dysmennorhea. Holloway's pharmaceutical company asked the FDA to approve Bextra for acute pain, including that associated with surgery. The FDA explicitly denied this use because it knew of a study in which patients who had undergone coronary artery bypass graft surgery experienced excess cardiovascular events. Eventually, Bextra was taken off the market.

Holloway knew about the FDA's concerns and that it had denied approval for use with acute pain. She told her sales force of 100 people to sell Bextra for those denied uses. Holloway directed her sales force to sell Bextra for acute pain associated with surgery, and she told them to sell it for unapproved dosages. Holloway also encouraged her sales staff to make false safety claims about the drug.

Pharmaceutical sales representatives struggling with unethical and illegal misconduct like Holloway's can assist the federal government in uncovering fraud by filing a False Claims Act complaint. Meritorious FCA claims can result in simultaneous civil and criminal actions, depending on the circumstances.