US Justice Department probing Abbott Lab's Depakote marketing

The US Justice Department is investigating Abbott Laboratories' sales and marketing activities for its anti-seizure drug Depakote (divalproex), its third top-selling drug, the US health care major revealed in a regulatory filing. It said that the US Attorney for the Western District of Virginia is seeking to determine whether Abbott's marketing activities violated civil or criminal laws, including the Federal False Claims Act, the Food and Drug Cosmetic Act, and the Anti-Kickback Statute "in connection with Medicare and/or Medicaid reimbursement to third parties."

Abbott spokeswoman Adelle Infante said the company is cooperating with the investigation, but declined further comment. Sales of Depakote, which is approved to treat bipolar disorder and seizures and to prevent migraine headaches, have been declining recently due to generic competition. They plunged 70% to $354 million for the first nine months of 2009, having reached annual revenues of around $1 billion previously.

Earlier this year, the US Food and Drug Administration sent Abbott a warning letter saying that a promotional material for Depakote was misleading and violated federal law. It said that a promotional flashcard shown to health care professionals omitted certain information about the drug's risks and overstated the approved uses of the drug. Abbott stopped using the material.

Federal investigations into pharmaceutical marketing, particularly as it relates to how brand name pills and capsules are marketed to physicians are common and have been on the rise over the last decade, opted the Chicago Tribune. Such probes have netted the federal government huge settlements as US prosecutors work to curb illegal practices they say lead to higher health care costs when companies push more expensive brand-name drugs, often over cheaper generics entering the market or rival brands, the newspaper stated.