Merck & Co. has been subpoenaed as part of a criminal investigation by the Department of Justice into the marketing of three of its drugs.
The pharmaceutical company disclosed the subpoena, which seeks information on marketing practices back to January 2004, in a filing with the Security and Exchange Commission.
The drugs at issue are Temodar, which treats brain tumors; the hepatitis C drug PegIntron; and Intron A, which is used to treat cancer and other conditions. All three drugs were marketed by Schering-Plough, which Merck acquired in 2009.
In its SEC filing, New Jersey-based Merck said the subpoena is part of a “federal health-care investigation under criminal statutes.” According to The Wall Street Journal, a company spokesman said Merck is cooperating with the probe but did not provide further comment about the case.
The Merck subpeona stems from a recent crackdown by the Justice Department on health-care fraud, including the alleged promotion of certain drugs for unauthorized uses, commonly called off-label marketing.
As FiercePharma reports, the Justice Department asked Cephalon in July for documents in an investigation of potential off-label marketing of the leukemia drug Treanda. Cephalon already has paid $375 million to settle an investigation into Provigil off-label marketing.
In addition, AstraZeneca has received a federal subpoena regarding its relationship with pharmacy benefits manager Medco Health Solutions, and Gilead Sciences is under a federal investigation of its manufacturing, quality control and distribution practices.
Merck has been the subject of other federal investigations, too. It has set aside $950 million to settle a federal probe of its research and marketing of the blocksbuster pain drug Vioxx, which Merck withdrew from the market in 2004 after it was linked to higher risks of heart attacks and strokes. A final settlement has not yet been announced.
In addition, the Justice Department and Environmental Protection Agency are seeking civil penalties of more than $2 million against Merck for alleged violations of environmental regulations at the company’s West Point, Pa., and Riverside, Pa., operations. Merck also said that it has agreed to pay a $260,000 fine and sign a consent decree to resolve alleged environmental violations at its Las Piedras, Puerto Rico, plant.


