Killer Disease on Campus

Student Handout

Case Studies

You have been assigned to a team of scientists who must determine whether a new drug should be put on the drug development fast track to combat a major threat to public health. Your team will review one of the case studies below and, based on the public health threat, decide whether the drug should be evaluated using the standard FDA New Drug Development Process or the Accelerated Development/Review Process. Be prepared to provide information to support your decision.

Scientific Research Team A
This past week, three small towns in Iowa were flooded with mail envelopes that contained one ounce of fine white powder. The white powder was determined to be a strain of inhalation anthrax. Of the three towns, 1,255 inhabitants have been exposed. They have inhaled aerosolized Bacillus anthracis, but do not yet have evidence of the disease. After the events in the fall of 2001, the Federal Drug Administration issued a request for a new treatment for people in this stage. The drug used to treat those persons is Ciprofloxacin(TM). The FDA however, has a need for additional antimicrobial drugs for people who are allergic to Ciprofloxacin or in case the bacteria should become resistant to the drug. Should these drugs be developed following the guidelines of the Accelerated Development Review Process or the standard FDA New Drug Development Process?

Scientific Research Team B
An urgent request has come from public health offices in New Zealand. Increasing numbers of people have malignant melanoma, a devastating and often fatal form of skin cancer that affects all ages. This has become a public health emergency. Thousands of people may be in jeopardy. There is an urgent need for new medicines due to the rapidly rising number of cases of advanced malignant melanoma. A new drug called Leukine(TM) shows promise. Should this drug be developed following the guidelines of the Accelerated Development/Review process or the standard FDA New Drug Development process?

Questions
Write your answers on a separate sheet of paper.

1. Does the need for an accelerated development review outweigh the risk of developing a drug with serious side effects? Explain.

2. Should the number of people affected influence whether the drug is put on a development fast track? Explain.

3. Why can't all drugs be put through the accelerated development process?

4. What would happen if drug development were not regulated?