More than four years after launching an administrative inquiry into Biovail's marketing of Cardizem LA (diltiazem) the Massachusetts Attorney General's office is bringing the matter before a federal grand jury.

Biovail announced in a Feb. 1 release that it had received notice from the attorney general that a grand jury would investigate the company's 2003 launch of Cardizem, particularly its "clinical experience" program.

Dubbed P.L.A.C.E. (Proving L.A. through Clinical Experience), the program was intended to get physicians to prescribe the long-acting formulation of the antihypertensive drug over other diltiazem products, including Biovail's Cardizem CD. Under the program, physicians who prescribed the drug to up to 15 patients and completed a questionnaire were entitled to receive $1,000.

Cardizem LA was approved in 2003 for administration in either the morning or evening while other once-daily diltiazem products did not include the nighttime-dosing option. When it launched Cardizem LA, Biovail said it would be aggressive in seeking to convert users of other diltiazem products to the long-acting formulation and would point to the high incidence of cardiac events in the morning as a reason for bedtime dosing.

The company's marketing efforts also caught the attention of the HHS Office of Inspector General, which initiated its own administrative inquiry in 2003.

Biovail said the grand jury investigation "could lead to possible civil or criminal charges."

-Brenda Sandburg (b.sandburg@elsevier.com)

Biovail’s Cardizem LA Marketing Under State Scrutiny

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