Economic evaluations in FDA drug approval process

| July 12, 2019

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Read on to learn more. Below is a sample economics paper. The first part is the question and the second one is the answer.

Questions:

Question 1
After the Vioxx incident, what is your perspective on the FDA and economic evaluations? Should an outside source be conducting this task?
Efficiency of the drug would have to be taken into account with the approval process. This is a true statement if we agree that economic evaluation should be included in the FDA approval of new drugs process. The birth of the Food and Drug Administration Modernization Act of 1997 was to bring about changes in the drug approval process, which included economic evaluation (U.S. FDA, 2009). Section 114 of the FDAMA addresses the use of health economic information in the drug approval process.
In consideration of economic evaluations, my thoughts go to the FDA approval of the drug Vioxx and the recall that took place sometime later. Some scientists believe that the FDA is hardly in a position to be the authority on economic evaluations when their integrity is in question (Union Concerned Scientists, 2012).
References:
Union of Concerned Scientists. (2012). FDA’s drug safety system fails to protect public. Scientific Integrity. Retrieved from http://www.ucsusa.org/scientific_integrity/abuses_of_science/vioxx.html
U.S. Food and Drug Administration (U.S. FDA). (2009). Food and Drug Administration Modernization Act of 1997. Retrieved from http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDAMA/FullTextofFDAMAlaw/default.htm#SEC. 114
Question 2

Do you think if economic evaluation is added there will be any change in behaviour of consumer and provider in healthcare system? (Phillips, 2009). Do you think effective drug analysis studies are better than efficacy drug trials? Do you agree if economic evaluation is added the way clinical trial phase 11 and 111 are conducted would be different? (Bombardier, 1999).

References
Bombardier C., & Maetzel, A. (1999). Pharmacoeconomic evaluation of new treatments: Efficacy versus effectiveness studies? Annals of the Rheumatic Diseases, 58(Suppl 1), I82–< span style=”border: 1pt none windowtext; padding: 0in;”>I85. Retrieved from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1766572/pdf/v058p00I82.pdf

Phillips, C., (2009), “Health Economic Evaluation”. Health Economics and Financial
Management in Clinical Research Administration. Baltimore. Authors: M.D.

 

Answers:

Title: Economic evaluations in FDA drug approval process

Question 1

The Viox incident unfolded in 2004 where Merck, a pharmaceutical company, voluntarily withdrew Vioxx, a pain medication, from the market after evidence showed that patients taking the drug were at a higher risk of suffering a heart attack. This single incident was an indication of FDA’s inability showed that the FDA had failed in its mandate to offer protection to American public.

According to Union of Concerned Scientists, (2012), there is ample evidence to show that even from the point of view of economic evaluations the FDA has been a failure. The Vioxx incident triggered a flurry of interest among critics of the FDA. Consequently, the Journal of the American Medical Association (JAMA) published a series of studies showing that there were serious flaws in FDA’s system of drug safety regulation (Union of Concerned Scientists, 2012). The efficiency of the drug and the economic evaluation ought to have been included in the FDA’s process of approving new drugs. However, the FDA failed in incorporating the element of economic evaluation into the process. This failure shows that an outside source should be tasked with the work of conducting this task.

Question 2

The incorporation of clinical and economic evaluation in the FDA has raised new issues relating to the design of clinical trials. In most cases, both aspects tend fail to be accorded the appropriate attention. For instance, there is a lack of proper timing with regard to economic evaluations during the development process of many drugs (Bombardier & Maetzel, 1999). According to Bombardier & Maetzel (1999), the pharmacoeconomic guidelines available appear to put more emphasis on clinical evaluation.

If economic evaluation is properly incorporated into the entire process of drug development, a drastic change will occur in the behavior of consumers as well as providers within the healthcare system. Moreover, effective drug analysis studies are much better compared to efficacy drug trials. In efficacy drug trials, focus is only on the question of whether the drug works as required under optimal circumstances. Additionally, as Bombardier & Maetzel (1999) points out, the way clinical trial phase II and III are conducted would be different if economic evaluation was incorporated into the whole process. The economic evaluation would provide the more relevant question of whether a drug will work in usual care.

 

References

Bombardier, C. & Maetzel, A. (1999) Pharmacoeconomic evaluation of new treatments: Efficacy versus effectiveness studies? Annals of the Rheumatic Diseases, 58(1), 182-185.

Union of Concerned Scientists, (2012) FDA’s drug safety system fails to protect public, Retrieved from http://www.ucsusa.org/scientific_integrity/abuses_of_science/vioxx.html on September 17, 2012.

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