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Scrutiny of Vytorin marketing continues

Pharma Compliance Alert, November 12, 2008

The Department of Justice (DOJ) and 35 state attorneys general are investigating how Merck and Schering-Plough marketed their combination cholesterol drug Vytorin, according to a Merck filing with the Securities and Exchange Commission.

Since December 2007, the companies have received letters from the House Committee on Energy and Commerce, its Subcommittee on Oversight and Investigations, and the Ranking Minority Member of the Senate Finance Committee seeking information about the ENHANCE trial and Vytorin sales and promotion. The Oversight and Investigations subcommittee also requested information about another clinical trial, SEAS, on August 21 and September 2.

The companies have each received subpoenas from the New York and New Jersey State Attorneys General Offices and a letter from the Connecticut Attorney General seeking similar information and documents. In addition, Merck has received five Civil Investigative Demands from a multistate group of 35 state attorneys general who are jointly investigating whether the companies violated state consumer protection laws.

The DOJ is also investigating whether the companies’ promotion of Vytorin caused false claims to be filed. If the DOJ can prove the allegations, federal health programs, such as Medicare and Medicaid, could try to recover money spent on Vytorin.

Since mid-January 2008, Merck has become aware of, or been served with, approximately 140 civil class action lawsuits alleging common law and state consumer fraud claims.

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