1.The Food & Drug Administration is a federal agency of the U.S. Department of Health and Human Services. Why does the U.S. government regulate the availability of new drugs?
2.Which drugs does the FDA regulate? What products doesn’t the FDA regulate?
3.As a reminder, during the testing of new drugs and vaccines, if the drug or vaccine for a life-threatening condition shows promise and there are NO alternative drugs or vaccines, the FDA can grant a drug company accelerated (fast track) conditional approval to bring the drug to market sooner, but the drug or vaccine must undergo all phases of typical drug testing. To obtain fast-track approval, the drug company must promise that it will continue testing the drug or vaccine in the post approval period and be prepared to withdraw the drug or vaccine from distribution if unknown problems occur. Given the current COVID-19 pandemic, a vaccination for the virus has been fast-tracked to human trials before animal testing was conducted.
In your opinion, does the need for a fast track vaccine outweigh the risk of developing a vaccine with serious side effects? Explain your response.
4.Should the number of people who could become sick with a disease or virus that is life-threatening impact whether or not a drug or vaccine gets fast tracked? (i.e., the drug or vaccine should only be fast-tracked if over 100 people are inflicted with the condition vs. only 5)? Why or why not?
Sample Solution