Drug Approval and the FDA

In Class Assignment: Drug Approval and the FDA

(20 Points)

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  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?


  1. Which drugs does the FDA regulate? What products doesn’t the FDA regulate?


  1. 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.


  1. 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?


  1. An urgent request has come from the CDC to evaluate an investigational vaccine designed to protect against COVID-19 (Corona Virus) given the high number of people that have become infected in the United States. The open-label, phase 1 trial will enroll 45 healthy adult volunteers, ages 18-45 for 6 weeks. The study is evaluating different doses of the experimental vaccine for safety and its ability to induce an immune response in participants. The vaccine is called mRNA-1273 and was developed by a biotechnology company called Moderna. At the end of this 6-week trial, positive results were found for a specific dose of the vaccine. The vaccine is ready for a phase 2 trial, but the lead scientist of the project comes to your team at the FDA with a request to skip phase 2 and 3 trials and bring the vaccine to market now.


Would you be willing to approve this request? Explain your response.








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