Merck & Co. has petitioned the FDA for permission to return Vioxx to the market, with additional warning labels and dispensing information. Both you and Dr. Sharpe have been appointed to a review panel that must make a written recommendation to the Assistant Director of FDA, either for or against allowing Vioxx back on the market. What would you recommend, and why?
In crafting your response, you may discuss the general issues with other staff members (members of your work group or class), and you are free to include research findings or data from outside primary resources. However, you must write your own individual recommendation and clearly explain the rationale for your recommendation. Your recommendation and rationale for it is limited to one typed page.
Originally published at http://www.sciencecases.org/vioxx/vioxx4.asp
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