Tuesday, June 18, 2019
Case Study Analysis Assignment Example | Topics and Well Written Essays - 1000 words
Case Study Analysis - Assignment Exampleof the superlative ironies surrounding the release of the do drugs into the earth domain was that some of the major personnel in FDA such as Merk were aware of the possible threats that were associated with the use of the drug were quite adamant to make it known (Richwine, 2004, November 18). They knew the drug increased risks of heart attack that make it pose as a great threat to public use. However, Charles Grassley one of the primary leaders in FDA initiated research to investigate the risks associated with the use of Rofecobix drug (Topol, 2004). In the course of this research, Dr. David graham flour an FDA reviewer disc everywhereed the risks associated with the use of the drug, and made a publication without obtaining any clearance from the FDA committee (PhamaLot, 2011, August 28).The primary leadership of FDA has a number of shortcomings most of which contributed to the clearing the drug for public use. The hot seat of the FDA commi ttee Charles Grassley equally raised concern that the relationship that existed between the drug companies and FDA was cozy and, therefore, could not provide room for the establishment of proper control over the drugs cleared (Topol, 2004). Some committee members have also been faulted for knowingly allowing the clearance of the drug and not warning people of the impending risks associated with the use of rofecobix. In addition, when David Graham published his findings, he was faulted by the acting commissioner of FDA, Lester Crawford, stating that Graham did not follow the correct procedures in making publication of his findings report (Richwine, 2004, November 18). Grassley, on the other hand, is on the opinion that Lester Crawford wanted to intimidate, Graham the reviewer and, therefore, his statements were purely meant to intimidate the witness before hearing (PhamaLot, 2011, August 28). The above crisis represents a management dilemma, which results into confusion and inconsis tency in the nature of research provided.The primary leaders
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