A Phase III trial of a new medication has been completed.
Data analysis reveals that the new medication is ‘statistically’ significant in giving a superior result from the standard treatment.
Then (as in the hypothetical case presented by Turner) the new medication is shown to have a small practical or clinical value. What factors might you use to argue in favor of FDA approval? How would you argue against FDA approval?
Week 4 Discussion
Respond to the following:
Review “The FDA Task Force,” in Chapter 4 of Managing the Public Sector.
• The author of the case study states: “Even though at least 60 percent of Americans disapprove of cloned food, the FDA in 2006 ruled that milk and meat from cloned animals should be allowed on grocery store shelves.
” As an FDA administrator, explain how you would respond to the public’s objections of the “respected colleague” about the use of control groups.
In your response, identify and explain which principles you applied.
Provide 1–2 examples to support your response.
• Some top administrators believe that they should welcome congressional oversight in areas in which committees or members have legitimate concerns.
Discuss 2–3 reasons a public administrator might hold this view.
Discussion: Prescribing for Older Adults and Pregnant Women
In this Discussion, you will investigate a specific disorder and determine potential appropriate treatments for when it occurs in an older adult or pregnant woman.
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To Prepare:
Choose one of the two following specific populations: either pregnant women or older adults. Then, select a specific disorder from the DSM-5 to use.
Use the Walden Library to research evidence-based treatments for your selected disorder in your selected population (either older adults or pregnant women). You will need to recommend one FDA-approved drug, one non-FDA-approved “off-label” drug, and one nonpharmacological intervention for treating the disorder in that population.
By Day 3 of Week 9
Recommend one FDA-approved drug, one off-label drug, and one nonpharmacological intervention for treating your chosen disorder in older adults or pregnant women.
Explain the risk assessment you would use to inform your treatment decision making. What are the risks and benefits of the FDA-approved medicine? What are the risks and benefits of the off-label drug?
Explain whether clinical practice guidelines exist for this disorder, and if so, use them to justify your recommendations. If not, explain what information you would need to take into consideration.
Support your reasoning with at least three current, credible scholarly resources, one each on the FDA-approved drug, the off-label, and a nonpharmacological intervention for the disorder.
