Drug Sales Manager Sentenced for Illegal Distribution of Pain Pill Bextra
A former drug company regional sales manager has been sentenced to two years’ probation and ordered to pay a $75,000 fine for illegally marketing the pain drug Bextra for treatments she knew could result in potentially deadly complications in patients.
Mary Holloway, 47, of Branchburg, N.J. pleaded guilty to federal charges of distributing a misbranded drug.
From about November 2001 to April 2005, Holloway oversaw sales of Bextra and other drugs in her region of the country, federal prosecutors said. Bextra was a Cox-II inhibitor and member of a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs) that was approved in November 2001 to treat osteoarthritis, rheumatoid arthritis, and primary dysmennorhea.
Bextra was withdrawn from the U.S. market in April 2005 after the Food and Drug Administration found it was linked to increased risks of heart attack, stroke, and other cardiovascular complications.
FDA Warnings Were Ignored
Holloway knew about FDA warnings of the risks of Bextra but instructed her approximately 100 sales employees to continue selling the drug for treatments the FDA had refused to approve, including treating pain following surgery, prosecutors said.
Holloway also instructed her sales team to market Bextra for use before, during and after surgery to reduce the risk of deep vein thrombosis, a condition which causes life threatening blood clots to form, even though she knew there were no studies showing that Bextra was safe and effective for this use, authorities said.
She also encouraged her staff to lie about the safety of Bextra in order to sell the drug, according to prosecutors.
Holloway’s conduct “undermined the FDA’s regulatory scheme and put patients at risk for the purposes of pursing profits for the individual and the pharmaceutical company,” officials 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,” said Acting United States Attorney Michael K. Loucks said.
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