Saturday, July 27, 2019

Case Study Analysis Assignment Example | Topics and Well Written Essays - 1000 words

Case Study Analysis - Assignment Example of the greatest ironies surrounding the release of the drug into the public 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 made 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 an FDA reviewer discovered 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 chairperson of the FDA committee 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 i ntimidate the witness before hearing (PhamaLot, 2011, August 28). The above crisis represents a management dilemma, which results into confusion and inconsistency in the nature of research provided. The primary leaders

No comments:

Post a Comment