FDA AND THE TESTING OF EXPERIMENTAL DRUGS
The Food and Drug Administration (FDA) of the federal government is one of the largest consumer protection agencies in the world. One of the FDA’s charges is to ensure that drugs sold to consumers do not pose health threats. As a result, the testing procedure that leads to a new drug’s approval is rigorous and demanding. So much so, in fact, that some policy makers are calling for less stringent standards. Here are some of the dilemmas that FDA faces:
● If an experimental drug shows promise in the treatment of a dangerous disease such as AIDS, should the testing procedure be abbreviated in order to get the drug to market more quickly?
● The FDA already is a large and costly bureaucracy. By easing testing standards, substantial dollars could be saved. But would it be more likely that a dangerous drug would be approved? What are the costs of such a mistake?
A fundamental trade-off is involved here. What are we gaining in the way of assurance of safe drugs, and what are we giving up by keeping the drugs away from the general public for an additional year or two?
1. What are the consequences (both good and bad) of keeping a drug from consumers for some required period of rigorous testing?
2. What are the consequences (both good and bad) of allowing drugs to reach consumers with less stringent testing?
3. Imagine that you are the FDA’s commissioner. A pharmaceutical company requests special permission to rush a new AIDS drug to market. On the basis of a first round of tests, the company estimates that the new drug will save the lives of 200 AIDS victims in the first year. Your favorite pharmacologist expresses reservations, however, claiming that without running the complete series of tests, he fears that the drug may have as yet-undetermined but serious side effects. What decision would you make? Why?
4. Suppose that the drug in Question 3 was for arthritis. It could be used by any individual who suffers from arthritis and, according to the preliminary tests, would be able to cure up to 80% of rheumatoid arthritis cases. But your pharmacologist expresses the same reservations as the AIDS drug. Now what decision would you make? Why?