This week’s Department of Justice “Catch of the Week” goes to Qualitest Pharmaceuticals. On Wednesday, the company’s corporate shell, Vintage Pharmaceuticals, its parent Endo Pharmaceuticals, and seven of their affiliates agreed to pay $39 million to settle charges they violated the False Claims Act by selling understrength chewable fluoride tablets. See DOJ Press Release.
As part of the settlement, Qualitest admitted the drug labeling for its chewable fluoride tablets represented fluoride amounts of 1.0 mg, 0.5 mg, and 0.25 mg in line with and specifically referencing the guidelines of the American Dental Association (ADA) and the American Academy of Pediatrics (AAP). However, Qualitest admitted using less than half of these represented amounts causing children taking the Qualitest fluoride tablets to receive less than half the recommended amounts by the ADA and AAP.
In announcing the settlement, Manhattan U.S. Attorney Preet Bharara made it clear the government takes a hard stand against drug makers mislabeling their products:
The integrity of federal healthcare programs like Medicaid depends on manufacturers telling the truth about their drugs and producing and labelling their drugs accurately. When companies violate that critical obligation, as Qualitest did here by distributing diluted fluoride and then causing health care programs to pay for the full strength tablets, we will pursue them, make them pay damages and admit to their violations.
He was joined in this strong sentiment by Scott J. Lampert, Special Agent in Charge of the New York Regional Office for the Office of Inspector General for the Department of Health and Human Services: “It is shocking that a pharmaceutical company would knowingly distribute diluted fluoride meant to provide preventative dental benefits to children as if it were full strength. We remain committed to investigating companies that put greed over their professional obligations to serve their customers and honestly bill for their products.”
The allegations were first raised in a whistleblower lawsuit brought Dr. Stephan Porter under the qui tam provisions of the False Claims Act. He will receive a whistleblower award of roughly $4.71 million from the proceeds of the government’s recovery.
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