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.
- 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
Vaccine Act of 1813
- First federal law concerning consumer protection and medicinal substances.
- Smallpox epidemics were a common occurrence throughout the 1700s and 1800s.
- Efforts were made to develop a vaccine for smallpox from cowpox scabs imported from England.
- The cowpox virus could not live very long in dried scabs.
- As a result, the virus was transmitted by arm-to-arm contact in successive person-to person inoculations.
- This means that an infected vaccination lesion on one person was scraped and used as material to inoculate the next person.
- This method is no longer used, as other infectious diseases were often transmitted along with the cowpox vaccine.
- The Vaccine Act mandated that a purer supply of the cowpox be sustained and be given to any citizen.
- Dr. James Smith was named as the first vaccine agent.
- He had 20 years of experience in the transmission of the cowpox vaccine through arm-to-arm contact every 8 days.
- However, in 1821 he accidentally sent smallpox crusts instead of the cowpox vaccine to North Carolina.
- The inoculation of patients with live smallpox led to a smallpox epidemic as well as the repeal of the Vaccine Act of 1813.
Import Drug Act of 1848
- Established customs laboratories
- Responded to counterfeit, contaminated or adulterated drugs being transported into the U.S.
- Prior to the passing of the act, American troops in Mexico had received counterfeit and ineffective medicines for malaria.
