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Pharmaceutical Company Manager Sentenced
for Off-Label Marketing
BOSTON, MA—A Branchburg, NJ, woman was sentenced today 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.
Acting United States Attorney Michael K. Loucks; Warren T. Bamford, Special Agent in
Charge of the Federal Bureau of Investigation, Boston Field Division; Susan J. Waddell, Special
Agent in Charge of the Department of Health and Human Services, Office of Inspector General;
Leigh-Alistair Barzey, Resident Agent in Charge of the Defense Criminal Investigative Service;
Kim A. Rice, Special Agent in Charge of the U.S. Food and Drug Administration, Office of
Criminal Investigations, Metro Washington Field Office, Special Prosecution Staff; Jeffrey
Hughes, Special Agent in Charge of the U.S. Department of Veterans Affairs, Office of Inspector
General, Office of Investigations - Northeast Field Office; and Joseph Finn, Special Agent in
Charge of the United States Postal Service, Office of Inspector General, Boston Field Office,
announced today that MARY HOLLOWAY, age 47, of Branchburg, New Jersey, 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.
At the plea hearing, prosecutors told the Court that, had the case proceeded to trial the
Government’s evidence would have proven, the following:
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. The FDA told the pharmaceutical
company that it could not approve it for these other indications because the safety in these other
uses had not been established. Specifically, 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.
HOLLOWAY was aware of the FDA’s safety concerns, but that she nonetheless had her
sales staff of approximately 100 employees sell Bextra for precisely the uses that the FDA
refused to approve. For example, 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 that Bextra was safe and effective for this use. Finally,
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.”
Bextra was withdrawn from the market in April 2005.
The case was investigated by the Federal Bureau of Investigation, the Office of Inspector
General for the Department of Health and Human Services, Special Prosecutions Staff for the
U.S. Food and Drug Administration, Office of Inspector General for the Department of Veterans
Affairs, the Defense Criminal Investigative Service, and the Office of Inspector General for the
United States Postal Service. It was prosecuted by Assistant U.S. Attorneys Sara Miron Bloom
and Susan M. Poswistilo of Loucks’ Health Care Fraud Unit.
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