Biomedical Engineering Reference
In-Depth Information
United States even before 1904. President Theodore
Roosevelt had called for legislation to regulate “misbranded
and adulterated foods, drinks, and drugs” in his State of the
Union statement in late 1905. Many factors combined to
lead to the passage and signing of the legislation, including
Sinclair's book.
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This was also the case with the Elixir Sulfanilamide
disaster of 1937, which was a critical episode in the
emergence of drug safety regulations. When the sulfa drugs
fi rst came to market, they were distributed in tablet form.
Soon, the S.E. Massengill Company developed a liquid
preparation. This was the Elixir Sulfanilamide, with
diethylene glycol (DEG), water, and sulfanilamide as the
main ingredients. The solvent, DEG, was not listed as an
ingredient, nor were existing animal studies of the solvent
consulted. The Elixir was distributed across the United States
in late 1937, and resulted in over 100 deaths due to DEG
poisoning.
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This tragedy contributed to the introduction of a bill that
eventuated in the Food, Drug and Cosmetic Act, signed into
law in June 1938. Among other provisions, it required that a
new drug application (NDA) provide evidence of drug safety.
As FDA Commissioner Walter G. Campbell had argued in
October 1937:
In the interest of safety, society has required that
physicians be licensed to practice the healing art.
Pharmacists are licensed to compound drugs. [. . .]
Certainly a requirement that potent proprietary
medicines be manufactured under license can be justifi ed
on the ground of public safety.
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Once again, many factors - including the tragedy itself -
combined to lead to the passage and signing of the legislation.
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