A former regional sales manager for Pfizer was sentenced recently to two years probation and a $75,000 fine for her role in an off-label drug promotion scheme. Mary Holloway, 47, was sentenced July 18 in Massachusetts District Court following her conviction for misdemeanor distribution of a misbranded drug, according to court records and a release from the U.S. Attorney’s Office.

Holloway pleaded guilty to the charge as part of a plea agreement she struck with prosecutors. According to the release, the Branchburg, N.J., woman orchestrated efforts to promote the pain drug Bextra (valdecoxib) for off-label uses and at unapproved doses from November 2001 to April 2005, when the drug was pulled from shelves amid concerns that it triggered heart problems.

U.S. Attorney Michael Louks, who heads up the Health Care Fraud Unit that prosecuted the case, said Holloway’s conduct “undermined the FDA’s regulatory scheme and put patients at risk for the purpose of pursing profits for the individual and the pharmaceutical company.”

Holloway ran sales for the northeast region of one of Pfizer’s divisions, and instructed her staff of 100 detailers and district managers to promote Bextra as a therapy for acute pain, including surgical pain, according to court records. However, the FDA had not approved the drug for that purpose and a request by Pfizer to expand its marketing to include acute pain had been rebuffed by the agency.

Specifically, 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” at 20 milligrams, an unapproved dose, the release stated. Holloway also told her staff to claim the drug could reduce the risk of blood clotting if taken before, during and after surgery, “even though she knew there were no studies showing that Bextra was safe and effective for this use.” Lastly, she “encouraged her staff to make false safety claims” in order to increase sales, the release states.

In a sentencing memo, Holloway acknowledged the illegality of her actions but contended that some were intended as a “salutary message” to the medical community, while in other cases she believed her conduct was “appropriate” and “consistent with corporate strategy.”

To find out more, see the August newsletter issues of the FDA Advertising and Promotion Manual and the FDA Enforcement Manual.