Sunday March 31, 2013
Megace: Potential Liability and Regulatory Impact
Par Pharmaceutical Co., has agreed to pay $45 million to settle
allegations it improperly
labeled and marketed its prescription drug Megace ES to elderly
patients, the U.S. Department of Justice said.
Among other things, the company was accused of criminally
misbranding Megace, which was approved by the FDA to treat weight
loss tied to AIDS, as a treatment for non-AIDS-related geriatric
Despite being aware of harmful side effects, Par also targeted sales to nursing home
residents with weight loss, and launched a sales force specifically
for this market, according to the Justice Department.
A representative from the company didn't immediately respond to
a request for comment. On behalf of Par, Chief Executive Paul V.
Campanelli pleaded guilty to criminal misdemeanor charges in a New
Jersey federal court on Tuesday, the Justice Department said. The
company was fined $18 million and ordered to pay $4.5 million in
criminal forfeiture, and agreed to pay $22.5 million to resolve its
civil liability. "Today's resolution emphasizes the importance of
the U.S. government's coordinated efforts to combat health care
fraud," said Stuart F. Delery, of the Justice Department's civil
division. "We expect companies to make honest, lawful claims about
the drugs they sell."
Megace, a megestrol acetate drug, lacked adequate directions for
use in the treatment of geriatric wasting unrelated to AIDS,
a use that wasn't approved by the FDA, the Justice Department said.
The civil allegations against the company were related to claims
submitted to federal
health-care programs for uses that weren't approved by the
FDA. U.S. officials alleged that Par was aware that
megestrol acetate carried potentially fatal risks for
elderly patients, including a heightened potential for deep
vein thrombosis and toxic reactions in patients with impaired
Please see the attached release from the U. S. Department of
Justice for additional details.
We wanted you to be aware of the above information as you
continue to review all medications in conjunction with your
Pharmacist and physician and work with your physician on providing
documentation in the event medications are used for off-labeled