Par Pharmaceutical to pay $45 mn to settle Megace ES drug off-label charges

Par Pharmaceutical Cos, a US maker of generic drugs yesterday agreed to pay $45 million to settle criminal charges for improperly marketing a drug to treat appetite loss in AIDS patients.

New Jersey-based Par, which was acquired by private equity firm TPG Capital for $1.9 billion in September last year, pleaded guilty to a charge that the company had improperly marketed its Megace ES drug for treating anorexia and malnutrition in elderly patients even though they did not have AIDS.

The drug has been approved by the US Food & Drug Administration (FDA) only for helping AIDS patients gain weight.

''The FDA requires drug makers to go through a stringent approval process before new drugs – or new uses for existing drugs – are made available to doctors and their patients,'' said Paul Fishman, US attorney for the District of New Jersey. ''Today, Par admitted that it chose to ignore that process in pursuit of more sales and greater profits. It is paying the price for its choice.''

The US Department of Justice (DoJ) began investigations after four whistleblowers revealed that Par was illegally encouraging physicians to prescribe Megace ES drug for elderly anorexia patients who had AIDS and filing false claims for reimbursement by federal health programs.

The whistleblowers, who were working with the company and resigned in 2009, had alleged that Par illegally marketed the drug for several years shortly after it was approved by the FDA in 2005.