The United States Department of Justice (U.S. DOJ) announced last week that a drug company manager has been sentenced for off-label promotion of <"https://www.yourlawyer.com/topics/overview/bextra">Bextra, a violation of the Food, Drug and Cosmetic Act. The manager marketed Bextra for uses and dosages that were not approved by the U.S. Food and Drug Administration (FDA).
In 2005, FDA and European regulators formally asked Pfizer, Inc. to suspend sales of Bextra in the U.S. and Europe. As a result, Pfizer announced it would immediately halt Bextra sales in the U.S. and European Union countries. The FDA stated that the risks—a high rate of heart attacks, strokes, other cardiovascular injuries, and Stevens Johnson Syndrome—posed by Bextra outweighed its benefits.
Bextra was a Cox-II inhibitor approved in by the FDA in November 2001 for the signs and symptoms of osteoarthritis and adult rheumatoid arthritis at 10 mgs and for primary dysmennorhea at 20 mgs, twice daily, as needed. In 2001, the FDA specifically denied Pfizer’s request to approve Bextra for acute pain, including surgical pain, because the safety in these other uses had not been established and it was specifically concerned about the results of a study in which there was an excess of cardiovascular events in patients who underwent coronary artery bypass graft surgery and used Bextra.
Mary Holloway, 47, of Branchburg, New Jersey, has been sentenced by U.S. Magistrate Judge Judith Dein to pay a $75,000 fine and twenty-four months of probation after pleading guilty to a so-called “Information†charging her with distribution of a misbranded drug. According to prosecutors speaking to the Court at the plea hearing, had the case proceeded to trial, the Government’s evidence would have proven that:
From approximately November 2001, through April 2005, Holloway was employed as a Regional Manager at a pharmaceutical company and was responsible for Bextra sales in her region.
Holloway was aware of the FDA’s safety concerns, but had her sales staff of approximately 100 employees sell Bextra for precisely the uses that the FDA refused to approve. The U.S. DOJ cited, as an example, that Holloway trained and encouraged her sales teams to promote Bextra by obtaining protocols from doctors that instructed that Bextra be used for the pain of surgery, an unapproved use, and at 20 mgs, an unapproved dose.
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 Bextra was safe and effective for this use.
Holloway encouraged her staff to make false safety claims about Bextra in order to sell the drug.
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 United States 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,†quoted the U.S. DOJ.
