This week, the U.S. Justice Department announced that drug maker, Merck, will pay a staggering $950 million to resolve investigations into the illegal marketing practices of its popular painkiller, Vioxx. Specifically, Merck will pay $321.6 million in criminal fines and $628.4 million as part of the civil settlement. The company will also plead guilty to charges of marketing Vioxx as a treatment for rheumatoid arthritis prior to receiving approval to do so from the U.S. Food and Drug Administration.
In 1999, the FDA approved Vioxx for use as a painkiller, but at that time, did not approve the drug as a treatment for rheumatoid arthritis. In fact, the FDA did not grant its approval for Vioxx to be used as a treatment for RA until April of 2002. Doctors could still prescribe Vioxx as a treatment for RA prior to 2002, but until it received the “ok” from the FDA, Merck could not legally market the drug for this condition. However, spanning a three year period, federal prosecutors said that Merck did, in fact, promote Vioxx as a treatment of RA. Moreover, the company continued to market Vioxx for RA even after receiving a warning letter to stop doing so from the FDA in September of 2001. In the end, studies revealed that use of the drug could increase a patient’s risk of heart attack and stroke, and Vioxx was pulled from the market all together in 2004.
In a statement issued on Merck’s website this week, the company noted that its civil settlement in no way constitutes an admission of liability or wrongdoing. Interestingly, given the news of Merck’s Vioxx settlement, many are now left wondering if Bayer AG faces a similar fate regarding the marketing of its controversial birth control pill, Yaz.
