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Biovail to Pay $24.6 Million to Settle Charges, Keep Federal Business
Biovail Pharmaceuticals, the U.S. subsidiary of Canada’s Biovail, has agreed to pay $24.6 million to settle criminal charges of improper marketing surrounding its commercial launch of Cardizem LA.
The settlement requires the company to plead guilty to paying thousands of physicians and other healthcare professionals as much as $1,000 each to induce them to prescribe or recommend Cardizem LA (diltiazem HCl) to manage blood pressure and chronic stable angina. The payments were made through the PLACE program, the U.S. attorney for the District of Massachusetts said in announcing the settlement.
Biovail said the agreement eliminates any criminal liability for the company and preserves its ability to conduct business in the U.S., although the government said the investigation is continuing. Without a settlement, the company risked being excluded from doing business with any health program sponsored by the federal government, which represents a substantial portion of its business, according to Biovail.
Beginning in March 2003, Biovail Pharmaceuticals “paid physicians and other prescribers up to $1,000 for enrolling between 11 and 15 patients in the program, causing patients to fill prescriptions for Cardizem LA. These included prescriptions that were paid for by Medicaid,” the Massachusetts U.S. attorney said.
Following an investigation by the FBI and the HHS Office of Inspector General, the U.S. attorney pressed charges over what the company and the government described as prior management’s actions.
The agreement is subject to approval at a court hearing expected to take place between July 31 and Sept. 15. It will not affect current or future Biovail medicines approved for use in the U.S., including the continued marketing of Cardizem LA, according to the company.