Merck Faces DOJ Drug Marketing Probe

Merck & Co. has been issued a subpoena by the U.S. Department of Justice (DOJ) as part of its criminal investigation into how Merck marketed its brain tumor medication, Temodar; its hepatitis C drug, PegIntron; and its cancer treatment, Intron A.

Merck explained that the DOJ is investigating how the drugs were marketed and sold from 2004 to present, said the Wall Street Journal. For most of that time, Schering-Plough, which was acquired by Merck in 2009, marketed the medications. Merck disclosed the subpoena in a Securities and Exchange Commission (SEC) filing yesterday and described the subpoena as being part of a “federal health-care investigation under criminal statutes,” the Journal reported.

Merck has been the subject of prior DOJ probes concerning a range of healthcare fraud allegations, said the Journal. Among those allegations, Merck was accused of promoting some drugs for nonapproved uses, added the Journal. In 2010, Merck put about $950 million aside for an emerging settlement in a federal investigation of how Merck researched, marketed, and sold Vioxx, explained the Journal.

Vioxx was approved for use in 1999, quickly becoming a bestseller for Merck, with annual sales of $2.5 billion; however, the painkiller was pulled off the market in 2004 after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003. The withdrawal prompted thousands of product liability lawsuits that claimed Merck didn’t properly warn doctors and patients of the drug’s risks. During the five years it was available, researchers believe Vioxx caused some 40,000 deaths.

In other Merck news, said the Journal, the company also disclosed that the DOJ and the Environmental Protection Agency (EPA) are considering civil penalties of over $2 million against Merck over allegations of environmental regulation violations at two Merck plants. The allegations against the West Point and Riverside Pennsylvania facilities arise from a 2006 EPA inspection of both sites and information Merck previously provided to the EPA, the Journal explained.

Merck also agreed to pay a fine of $260,000 and to sign a consent decree to resolve other allegations of environmental violations at its Las Piedras, Puerto Rico, facility; this, in response to a 2008 EPA inspection and concerning that location’s leak-detection and repair program, said the Journal.

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