The Vioxx Recall - Merck and FDA

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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
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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 found that “two thirds of the survey lacked confidence that adequately monitors the safety of prescriptions once they are on the market” (Lawrence, 483). Because there was pressure to get drugs into the market the FDA shortened the approval time which caused the approval percentage to increase from 1.56 percent to 5.35 percent in 2001. While at the same
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