Merck and Schering-Plough, along with their joint venture, Merck/Schering-Plough Pharmaceuticals, have reached a civil settlement of $5.4 million with a group of attorneys general representing 35 states and Washington, D.C., who investigated whether the companies violated state consumer protection laws in connection with the ENHANCE trial or by their promotion and marketing of Vytorin and Zetia.
As part of the resolution, the companies, which will merge later this year, agreed to reimburse the investigative costs of the 35 states and Washington, D.C., which totaled $5.4 million. Under the settlement, they are not required to make any other payment, nor required to admit any misconduct or liability.
In the settlement, the companies agreed to continue to comply with the Food, Drug and Cosmetic Act, the FDA Amendments Act and other laws requiring the truthful and non-misleading marketing of pharmaceutical products and made other voluntary assurances of compliance related to the promotion of Vytorin and Zetia.
The companies initially withheld the results of the ENHANCE study (Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia), which revealed that Vytorin failed to produce better results than Merck's older Zocor cholesterol drug. Vytorin was not found to be superior to the less expensive Zocor (simvastatin) in reducing plaque in the carotid arteries.
In addition to the District of Columbia, the 35 states participating in the agreement are: Arizona, Arkansas, California, Colorado, Delaware, Florida, Hawaii, Idaho, Illinois, Iowa, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia and Wisconsin.