The Leadership at Food and Drug Administration - Essay Example

The Leadership at Food and Drug AdministrationA close analysis of the case shows that Merck and the leadership at Food and Drug Administration (FDA) are the primary leaders responsible for all issues that took place in this case. The FDA granted permission to Merck to market rofecoxib (Vioxx) and it generated more than $2.5 billion but surprisingly, the company withdrew the drug as a result of excess risk of myocardial infarctions and strokes. The responsible people in this case did not take appropriate action to safeguard the health concerns of the people though several studies had shown that this drug has side effects in the people involved.

Merck and the FDA reneged on their responsibilities to the public which can be regarded as unethical in their health care profession.Skills and traits of the leadersThe traits of Merck for instance are oriented towards generating revenue at the expense of the health of the consumers of rofecoxib. He prioritises commercial interests ahead of the public health concerns. This is shown by his audacity to spend more than $100 million per year in direct-to-consumer advertising. On the other hand, it can be noted that the FDA which could have stopped Merck from using direct-to-consumer advertising as a result of the fact that cardiovascular toxicity was real since it received considerable confirmation in multiple studies did not act decisively.

The leadership at FDA and Merck share the responsibility of not taking appropriate action meant to safeguard the interests of public health. ReferencesTopol, E,J, (2004). ‘Failing the public health- Rofecoxib, Merck, and the FDA,’ The New England Journal of Medicine, 351(17), 1707-1709.