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The Vioxx Recall Merck And Fda

2853 words - 11 pages

The Central Problem
In the Merck, the FDA, and the Vioxx Recall case study, the question as to whether or not Merck conducted itself in a socially responsible and ethical manner with regard to Vioxx is the central problem we will examine in this case. Many argue that the sole problem lies within the pharmaceutical company Merck and Co., Inc., and while that may in fact be the case, other parties such as the Food and Drug Administration (FDA) can be held responsible as well. Merck a “research driven” pharmaceutical company “dedicated to putting patients first,” is one of the largest pharmaceutical companies throughout the world (Presley, 2). The American pharmaceutical giant manufactures, markets, research and develops a variety of health products worldwide. Vioxx, a selective COX-2 inhibitor drug designed to treat pain and inflammation, is one of such products that became the company’s bestselling-prescription painkiller; after the FDA approved the drug for treatment in May of 1999. The blockbuster drug generated more than 2.1 billion dollars in sales throughout the United States alone and proved to be a winning product for the company. A few years later in 2004, the drug was voluntarily recalled by Merck after results from a clinical trial [it conducted] resulted in findings of increased heart attacks amongst users who had been on the drug for over eighteen months. (Presley, 1) Prior to these findings, studies conducted by VIGOR, Cleveland Clinic, and Kaiser Permanente also yielded results of the drugs’ risks associated with increased heart attacks; however, Merck ignored such warnings—including a warning letter from the FDA about the risks associated with the drug. Once the company learned of the findings from its internal study, it immediately notified the FDA that it was voluntarily recalling the product. By this time Merck hadn’t fully considered its stakeholders and how its decisions to both ignore the warnings from the findings as well as how recalling the drug would affect consumers and the company at large. Merck focused solely on financial gains and the impact the drug had on company revenue, neglecting its ethical responsibility to both consumers and its shareholders.
Important facts of the case
If you search the web regarding Merck, the FDA, and the Vioxx Recall you’ll find a number of primary and secondary sources with central facts regarding the Vioxx case. While there are a number of variables to consider, I focused on the factual data that provided integral facts about this case. In the early 90s congress passed the Prescription Drug User Fee Act (PDUFA) that requires pharmaceutical companies to pay the FDA to review proposed medicines. This came as a result of pressure to get drugs into the market quickly as consumers were fearful that they were not receiving medicines quickly. This act allows the FDA to provide reviews that approve or disapprove various drugs—companies seek to enter into the market; yet the process was...

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