FDAnews Drug Daily Bulletin

The U.S. attorney’s office in Boston has notified Biovail it is the target of a federal grand jury investigation into its activities during the 2003 commercial launch of its hypertension and angina drug Cardizem LA.

The investigation focuses on the Cardizem LA (diltiazem HCl) clinical program, Proving L.A. through Clinical Experience (PLACE). The company said the investigation, which could lead to possible civil or criminal charges, began as an administrative inquiry. The company said it has cooperated fully and will continue to do so. It has been invited to provide evidence and arguments to the U.S. attorney’s office, which it said it intends to do “as soon as practicable.”

Biovail cannot comment further on the grand jury probe, Nelson Isabel, vice president of investor relations and corporate communications, said. However, he pointed to the company’s annual filing from May 2007 in which the company said it had received a subpoena from the U.S. attorney general in Boston in July 2003 requesting information on promotional and marketing activities surrounding the commercial launch of Cardizem LA and the PLACE program in particular.

In that filing, the company said it had met with the U.S. attorney and described the precautionary steps it took to ensure that the program complied with applicable rules and regulations, including relying on advice from various external advisers and a representative from the company that Biovail engaged to design PLACE.