The FDA was concerned about Bextra’s claims for use in acute pain and the FDA specifically denied the request of the pharmaceutical company to approve it in 2001.  The FDA told the pharmaceutical company that they could not approve the drug for a myriad of other uses. According to Pharmaceutical Online, “the FDA was concerned about the results of a study in which there was an excess of cardiovascular events in patients who had undergone coronary artery bypass graft surgery and used Bextra.”

But marketer, Mary Holloway of Branchburg, New Jersey, thought otherwise. She knowingly marketed Bextra for the specific uses not approved by the FDA and even instructed her staff of 100 to do this same.  Holloway has been sentenced by United States Magistrate Judge Judith Dein to pay a $75,000 fine and twenty-four months of probation after pleading guilty to an Information charging her with distribution of a misbranded drug.

What possessed Holloway to knowingly go against the FDA’s regulation and potentially putting consumers of the drug Bextra at risk?

Bextra was pulled from the market in 2005.

For more information on Holloway and the Bextra case, please visit the referenced article here.

Pharmaceutical Company Manager Sentenced For Off-Label Marketing