Biomedical Engineering Reference
In-Depth Information
Table 6.2
Critical episodes in the history of the FDA
■
Upton Sinclair's
The Jungle
1906
■
Elixir Sulfanilamide
1937
■
Thalidomide
1960s
■
Tylenol tampering
1982
■
Salmonella
contamination
2000s
summarized in four or fi ve critical episodes, including the
origin of federal regulations, the development of drug safety
regulations, and other episodes (Table 6.2). Several threads
can be drawn from these illustrative episodes, and presented
in the NEO program.
The fi rst thread
discusses public concern and offi cial
responses to these crises - legislative responses such as the
Food, Drug and Cosmetic Act of 1938, as well as regulative
responses such as 21 CFR 58 and ∫211. That thread provides
an opportunity to summarize the history of the FDA for the
new employees.
As an important episode in the origin of federal regulation,
take Upton Sinclair's book
The Jungle.
It was based on
Sinclair's own investigative journalism in late 1904 in the
Chicago stockyards and meatpacking industry. This topic
was serialized in the journal
Appeal to Reason
in early 1905,
and was published by Doubleday in early 1906. It graphically
recounted the plight of workers and the adulteration of food
that characterized the meatpacking industry. This topic
dramatically disclosed the problems in the industry, and its
publication and popularity contributed to the signing of the
Pure Food and Drugs Act in June 1906.
16
The topic is a crucial factor in the emergence of the 1906
legislation. It should be stressed that there had been
widespread concern about adulterated food and drugs in the
