Healthy Skepticism Library item: 15380

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Convey E.
Drug sales exec pleads guilty in Bextra case
Boston Business Journal 2009 Mar 30
http://boston.bizjournals.com/boston/stories/2009/03/30/daily25.html

Full text:

A former drug company sales executive pleaded guilty in Boston federal court to telling the roughly 100 representatives under her supervision that they should promote a pain drug for uses she knew had been rejected by the Food and Drug Administration.

Mary Holloway, who is 47 years old and lives in New Jersey, was a regional sales manager for a company listed in court documents as Pharmco. The drug she pleaded guilty to inappropriately selling carried the brand name Bextra. The painkiller has since been pulled from the market by Pfizer Inc. (NYSE:PFE), which had acquired its prior owner.

“Holloway was aware of the FDA’s safety concerns, but…she nonetheless had her sales staff of approximately 100 employees sell Bextra for precisely the uses that the FDA refused to approve,” U.S. Attorney Michael Sullivan’s office wrote in a news release.

Holloway pleaded guilty to one count of distribution of a misbranded drug. Under federal guidelines, she could be sentenced to six months in prison and a fine of $100,000. But according to court documents, Sullivan’s office agreed to recommend two years’ probation and a $75,000 fine.

In recommending the reduced sentence, Sullivan’s office cited Holloway’s “prompt acceptance of personal responsibility…and information known to the U.S. attorney at this time.” The nature of that “information” is not disclosed.

Holloway’s involvement with prosecutors dates at least to January 2006, court records indicate.

Court documents available Monday night don’t suggest any injuries were linked to dosages prescribed by doctors who received inappropriate advice linked to Holloway.

Late last year, Massachusetts Attorney General Martha Coakley and counterparts in three dozen states entered into a civil settlement related to the marketing of Bextra and a related drug.

The investigation continues, Sullivan’s office said.