Vioxx

Paper instructions:
The following questions must be answered in the paper.
#1) Begin the paper with identifying the process a pharmaceutical company must follow to seek drug approval before the
FDA
#2)Then tell about the FDA and internal procedures and clinical requirements for a drug to be approved when requested by
a company.
#3)What was the background for approval of Vioxx?
#4) Was it fully considered by Merck and the FDA before approval?
#5)How many independant studies were conducted about the drug after the FDA approval and what prompted them to be
conducted?
#6)Did thses studies shed bad light on the FDA approval process?
#7)What did Merck do in response to these studies?
#8) Why did Merck remove Vioxx?
#9)What did the FDA do in monitoring Vioxx?
#10) Did thr FDA take any action against Merck?
Did Merck act ethically? What must a company do to inform the public about potential risks of a product?