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Pharmaceutical Company Manager Sentenced for Off-Label Marketing

By Robert David, Esq.

A Branchburg, NJ, woman, Mary Holloway, age 47, was sentenced in U. S District Court in Massachusetts 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. According to government prosecutors: From approximately November 2001, through April 2005, HOLLOWAY was employed as a Regional Manager at a pharmaceutical company and was responsible for sales in her region of the drug Bextra. Bextra was a Cox-II inhibitor and had been approved in by the Food and Drug Administration (FDA) in November 2001 for the signs and symptoms of osteoarthritis, adult rheumatoid arthritis, at 10 mgs and primary dysmennorhea at 20 mgs, twice a day as needed. In 2001, the FDA specifically denied the request of the pharmaceutical company to approve it for acute pain, including the pain of surgery...continue to full post

Full post as published by Health Care Fraud Blog on June 19, 2009 (boomark / email).