Evolution of U.S. Drug Laws - Food and Drug Act of 1906/ Nuremberg Code

Food and Drug Act of 1906

• First comprehensive U.S. drug law
• Followed the 1905 release of a book by Upton Sinclair called "The Jungle", which exposed the unsanitary conditions of Chicago's meat-packing industry and led to legislation requiring processing inspections and forbidding interstate and foreign commerce in both impure and mislabeled food and drugs
• Did not require drugs to be effective, but it did require "that drugs meet standards of strength and purity.  The burden of proof was on FDA to show that a drug's labeling was false and fraudulent before it could be taken off the market." - quoted from www.fda.gov.
• Prior to 1907, medications were bought and sold like any other good.  There was no requirement to reveal the ingredients of a drug.
• In 1938, as a result of 107 deaths from "Elixir Sulfanilmade", the FDA was able to require drug manufacturers to prove the safety of a drug before it could be sold to the public.

Nuremberg Code

• Formed in 1947 in response to Nazi abuses of prisoners during World War II
• First international ethical guidelines for clinical research
• Required that volunteers provide informed consent prior to participating in experiments and that the benefits of the research be weighed against the risks and discomforts of the patients