Philip Hilt, author of Protecting America’s Health, contended that three conditions needed to be in place for sweeping regulatory change to happen. Two are certain by historical record and one is, perhaps, controversial. What are the certain conditions?
What tragedy, in part, prompted the 1938 Food Drug and Cosmetic (FD&C) Act?
The Thalidomide tragedy showed that the regulations being developed in the United States, at the time, were inconsequential and incapable of preventing catastrophic public health crises. Is this statement true or false, and why?
The significant changes to the FD&C Act, brought about the the Kefauver-Harris Amendment, made sure drugs met two clear criteria as a part of their approval. Drugs must be shown to be ____ and ____ before being approved. Previous to this amendment, drugs were only required to be ____ before approval. Fill in the blanks.
Why do YOU think it is important to understand the history of FDA regulation?
The Poison Squad can be considered one of the first clinical trials, started by Dr. Harvey Wiley. The goal of his studies was to determine the health effects of ____. Give several reasons why such an undertaking would not be allowed today.
What’s the difference between a device, a biologic, and a drug?
Understand the difference, and the importance, of the quality attributes of a drug. Convince yourself of ways that a drug could be either (or both) unsafe or ineffective if any one of those attributes were not met.
Why is it a worthwhile exercise to consider something like herbal remedies in the context of the quality attributes and the treatment of human disease?
