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Economic Evaluation
Should economic evaluation play a role in the FDA's new drug approval process? Why or why not?
The Food and Drug Administration (FDA) is the agency charged with the responsibility of making certain that the medicines accessible to the general public are safe and efficient. By tradition, the decision made by a government to overtly fund a drug was made at the cabinet level by a professional review committee, subsequent to a deliberation and endorsement with regard to the levels of efficacy and safety. Economic evaluation should play a role in the new drug approval process of the FDA. This is for the reason that pharma economic evaluations, in effect, necessitates pharmaceutical companies to illustrate cost effectiveness prior to their launch, in addition to quality, safety and efficacy, which are usually the initial three obstacles commonly enforced by licensing authorities (Bombardier and Maetzel, 1999). However, the downside to this is that it may in actual fact slow down the process of approval (Bombardier and Maetzel, 1999). This in general influences the aspect of the right timing for economic evaluations in the drug developmental practice. Idyllically, from the government and formulary standpoint, pharmaco-economic data ought...
In the present, a number of trials, for instance, in this case, such as present phase III trials, predetermined to assess safety and efficacy may not yet be able to provide a solution to the question regarding the effectiveness of a new drug (Bombardier and Maetzel, 1999).
What would the impact be of using economic evaluation on the development of new drugs?
Taking all matters into consideration, there would be a positive and constructive impact in the use of economic evaluation for the development of new drugs. First and foremost, in general, the impact of using economic evaluations in the development of drugs is that first of all, it would be beneficial in price negotiations and concessions. In addition, it would assist agencies to be able to target drugs at the specific patients who are most likely going to benefit from them. This will be all the more constructively impactful as the increasingly high prices of several new drugs, especially for diseases such as cancer, and the incremental instead of considerable enhancements in health improvement that numerous of these products supply, have made economic…
References
Jacobs, P. (2011). Are economic evaluations an important tool in vaccine policy decisions? Expert review of pharmacoeconomics & outcomes research, 11(5), 507-511.
Bombardier, C., & Maetzel, A. (1999). Pharmacoeconomic evaluation of new treatments: efficacy versus effectiveness studies? Annals of the rheumatic diseases, 58(suppl 1), I82-I85.
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