Wednesday, November 09, 2011

Merck Told to Submit Marketing Information -

Merck & Co. has received requests from government investigators for information about the marketing of heart and anti-infective drugs, continuing the heightened government scrutiny of the pharmaceutical industry.

In a separate legal development, Merck also said it has agreed to pay $49.5 million to settle certain class-action lawsuits related to its former painkiller Vioxx, which Merck withdrew from the market in 2004 after it was linked to increased risk for heart attacks and strokes.

The Justice Department has investigated Merck and other major drug makers for possible acts of health-care fraud in recent years, including the alleged promotion of certain drugs for unauthorized uses. This has led to some large settlements, most recently with GlaxoSmithKline PLC's agreement to pay $3 billion to settle multiple investigations related to its drugs.

The U.S. Justice Department issued a subpoena to Merck requesting information about marketing and selling activities for the heart drug Integrilin and antibiotic Avelox, from January 2003 to June 2010, Merck said in a filing with the Securities and Exchange Commission Tuesday. Merck said the subpoena was part of a civil federal health-care investigation, and that the company is cooperating.

Merck, of Whitehouse Station, N.J., inherited Integrilin and Avelox with its 2009 purchase of Schering-Plough for $49.6 billion.

In addition, Merck said the Justice Department has issued a civil investigative demand to Inspire Pharmaceuticals, a company Merck acquired in May for $420 million. The demand is part of an investigation of allegations that Inspire caused the submission of false claims to federal health-care programs for the drug AzaSite by marketing it for uses not approved by the U.S. Food and Drug Administration.

Drug companies are barred from actively promoting "off label" uses for drugs, though doctors have the discretion to prescribe drugs off-label.

Posted via email from Jack's posterous

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