Merck, Schering-Plough Reach Vytorin Settlement With State AGs
|Date Posted: July 17, 2009|
Merck & Co., Schering-Plough Corp. and their cholesterol joint venture Merck/Schering-Plough Pharmaceuticals reached a civil settlement with the attorneys general (AGs) of 35 states and the District of Columbia concerning the companies’ promotion of the drugs Vytorin and Zetia and the alleged delay in releasing the results of a related clinical trial.
According to the state enforcement officials, a nearly two-year delay in the release of the full results of the so-called ENHANCE clinical trial violated state consumer protection laws. The trial determined that Vytorin, a cholesterol-lowering drug consisting of a combination of the drugs Zetia and Simvastatin, was no more effective in reducing the formation of plaque in carotid arteries than the cheaper, generically available Simvastatin alone. During the delay in the release of the trial results, the companies heavily promoted Vytorin in direct-to-consumer (DTC) advertisements.
Under the settlement, announced July 15, the companies agreed to provisions included in a May 2008 settlement agreement with the states concerning Merck’s pain relief medication Vioxx, which was withdrawn in September 2004 due to safety concerns. Under the terms of the new agreement, according to Arizona Attorney General Terry Goddard, the companies must:
• obtain preapproval from the FDA for all DTC advertisements;
• comply with FDA suggestions to modify their drug advertising;
• register their clinical trials and post the trials’ results;
• reduce the possibility of conflicts of interest involving external Data Safety Monitoring Boards for company-sponsored trials; and
• comply with other detailed rules to prevent the deceptive use of clinical trial results.
The companies also agreed to pay the states $5.4 million to cover the costs of the investigation.
The settlement does not include any admission of misconduct or liability on the part of the companies. Bruce N. Kuhlik, executive vice president and general counsel of Merck, said that the agreement was consistent with the companies’ belief that they “conducted the ENHANCE trial in good faith and that their promotion of Vytorin and Zetia was in compliance with the law.”
Additional information on the settlement is on Thompson Publishing Group’s www.ctcomply.com, and will be included in the August issue of the FDA Advertising and Promotion Manual, and the September editions of the FDA Enforcement Manual and Guide to Good Clinical Practice newsletters.