Mary Holloway, a former Pfizer Regional Manager, was sentenced today for violating the Food, Drug and Cosmetic Act, for marketing the drug Bextra for uses and dosages that were not approved by the Food and Drug Administration.

A magistrate judge sentenced Holloway with a $75,000 fine and twenty-four months of probation after she pleaded guilty to distributing a misbranded drug, Bextra.

From November 2001 - April 2005, Holloway was responsible her region’s Bextra sales. Bextra, approved in 2001, was a treatment option for osteoarthritis, adult rheumatoid arthritis and primary dysmennorhea. The FDA, however, specifically denied Pfizer’s request to approve it for acute pain such as after surgery pain. Specifically, the FDA was concerned with study results that showed there were excessive cardiovascular events in patients who had undergone coronary artery bypass graft surgery and used Bextra.

Holloway, aware of the FDA’s safety concerns and rejection of Bextra for certain uses, had her sales staff of 100 employees sell Bextra for precisely the uses that the FDA refused to approve. For example, Holloway trained and encouraged her sales teams to promote Bextra by informing doctors that Bextra could be used for the pain of surgery, an unapproved use. Holloway also instructed her staff to market Bextra for use before, during and after surgery to reduce the risk of deep vein thrombosis, which is a form of life threatening blood clots, even though she knew there were no studies showing that Bextra was safe and effective for this use. Finally, Holloway, in general, encouraged her staff to make false safety claims about Bextra in order to increase sales.

Acting United States Attorney Michael K. Loucks said, “We will continue to hold individuals responsible for their conduct in promoting pharmaceutical drugs outside of the uses for which they have been found to be safe and effective by the FDA. The conduct at issue here undermined the FDA’s regulatory scheme and put patients at risk for the purpose of pursing profits for the individual and the pharmaceutical company.”

Bextra was withdrawn from the market in April 2005.

For more information please see: http://www.usdoj.gov/usao/ma/Press%20Office%20-%20Press%20Release%20Files/June2009/HollowayMarySentencingPR.html