Merck & Co., Schering-Plough reach civil settlement in US regarding the promotion of Vytorin, Zetia

Merck & Co. and Schering-Plough reported Wednesday that the companies agreed to pay $5.4 million to settle civil claims that they breached state consumer protection laws regarding an investigation into the promotion of Vytorin (ezetimibe/simvastatin) and Zetia (ezetimibe).

The drugmakers noted that the settlement, which reimburses investigative costs incurred by a group of 35 states and the District of Columbia, "does not require the companies to make any other payment, and does not require or include any admission of misconduct or liability." As part of the agreement, Merck and Schering-Plough said they will continue to abide by FDA regulations for the promotion of pharmaceutical products, and the companies indicated that they "made other voluntary assurances of compliance related to the promotion of Vytorin and Zetia."

According to allegations made by the states' attorneys general, Merck and Schering-Plough delayed the release of unfavourable results for Vytorin and Zetia from the ENHANCE trial, which was completed in May 2006, and heavily promoted the products prior to announcing the findings in January 2008. Massachusetts Attorney General Martha Coakley said the deal requires Merck and Schering-Plough to receive FDA approval before broadcasting any television advertisements for the drugs, and to meet certain criteria when providing data about clinical studies in media outlets. In addition, the settlement is reported to include restrictions on the ghostwriting of medical articles.

A spokesperson for Merck noted this is the first resolution of any ENHANCE-related legal matters, but that some other legal matters connected with the clinical trial are pending.

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