Important changes to the regulation of drugs by the Food and Drug Administration occurred in 1938 and 1962, largely in response
to: a. testimony by medical doctors. b. pressure from the drug manufacturers. c. the Elixir Sulfanilamide poisonings and birth defects from thalidomide. d. increased smuggling.
c. the Elixir Sulfanilamide poisonings and birth defects from thalidomide.
Explanation:
Befor the 1938, the Food and Drug Administration as a regulatory body in the United States was increasingly narrowed down in its regulatory activities by courts. These courts sets high standards and very high requirments for the regulatory agency to prove that there was a fradulentintent in a particular products before they can regulate a product by either banning it, removing it from market e.t.c.
for example, the the Elixir Sulfanilamide poisonings which killed over 100 people. They FDA could not have done anything due to the existing laws at that time if not for the<em> misbranding issue on the drug</em>. This particular issue lead to the changes that took place towards effective regulatory activities by the body.
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