A Branchburg, New Jersey woman who was employed as Regional manager of a Pharmaceutical company was sentenced upon criminal conviction for having instructed sales reps to market a drug product for conditions for which it had not been approved. The drug, Bextra, was a Cox-II inhibitor which had been approved for symptoms of osteoarthritis, and rheumatoid arthritis but which had not been approved for acute pain in general, including the pain of surgery. The FDA had told the company that it could not approve the product for these other conditions without further tests and studies to assure safety and efficacy.
The manager was aware of the FDA's concerns, but instructed her staff to market the product for the unapproved pain use. The manager pleaded guilty and was sentenced to 24 months of probation and a fine of $75,000 by United States District Court in Boston. This case demonstrates how seriously the FDA takes its criminal enforcement responsibilities and the danger in marketing a drug product for unapproved uses. It also highlights that the FDA will prosecute responsible employees rather than the company itself, for violations of the Act.
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