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History of the FDC Act

Some Of the early legislative and pivotal developments that receded the FD&C act were the following. In 1 820, the United States Pharmacopoeia (USP) was formed. Initially the USP consisted of a group of pharmacist members whose mission was to create a system of standards, a system of quality control, and a national formulary for drug compounds. At its start only 217 drugs that were able to meet the criteria were initially admitted. l In 1848, President James K. Polk, signed the Drug Importation Act.

This was in direct response for the need for legislation to stem the flood of adulterated products that were being imported into the united States from Europe and other countries. Because this law was exclusively aimed at imported products, a major deficiency of the law was that it did not include any provisions for domestic products. 2 This deficiency would eventually require future legislative actions in order to be corrected. In 1902, the Biologics Control Act was passed.

The Biologics Control Act was a result of two separate tragic incidents in which 22 children died as a result of contaminated vaccines. The first incident occurred in St. Louis in 1901 when 13 children died as a result of receiving a contaminated diphtheria antitoxin serum made from the blood of a horse that had contracted tetanus. The econd incident occurred shortly after in Camden, N. J. when 9 children died from tetanus after receiving a contaminated smallpox vaccine. The Biologics Control Act included the regulations for vaccine and antitoxin producers and required both licensing and inspections of manufacturers. The act also provided for the formation Of the Hygienic Laboratory which was the predecessor to the modern day Center for Biologics Evaluation and Research (CBER). The standards imposed by the act resulted in bankruptcy for one- third of the companies that where manufacturing antitoxins and vaccines while benefiting those manufacturers who were compliant. Ten firms held licenses with the Laboratory of Hygiene following the 1902 act. In 1 906, the LJnited States Congress passed the first food and drug law known as the Pure Food and Drug Act (PFDA). The PFDA is also known as the Wiley Act, named after Dr. Harvey W. Wiley who served as the chief chemist for the Bureau of Chemistry of the united States Department of Agriculture. The Pure Food and Drug Act was passed as a direct result of Dr. Wileys efforts to scientifically prove that many of America’s foods and drugs were adulterated, or the products strength or purity were suspect or misbranded, or the roducts had inadequate or inaccurate labeling. Other contributing social factors that had an influence on the passage Of the PFDA included strong public support for legislation as a result of several widely published articles about adulterated food and patent medicines in popular magazines such as Collier’s and McClure’s as well as the 1906 expose of the Chicago meat packing industry as characterized in the book “The Jungle” by Upton Sinclair. 6 In 1 911, the Sherley Amendments were enacted which prohibited the labeling of medications with false therapeutic claims that were intended to defraud the consumer.

Like the Drug Importation Act of 1848, the Sherley Amendments also had a deficiency in that these amendments required the government to find proof of intentional labeling fraud. Thus, the burden of proof was placed on the government and not the manufacturer. 7 The final culminating event that precipitated Congress to take dramatic legislative action to enact the Food, Drug and Cosmetic Act was a very tragic incident that occurred in 1937. During that year, 107 people mostly children, were killed by a highly poisonous medicinal mixture named “Elixir Sulfanilamide” which was distributed by a company named S. E.

Massingill, a pharmaceutical manufacturer located in Bristol, Tennessee. 8 The companys chief pharmacist Harold Watkins, created a preparation of Sulfanilamide by mixing a deadly combination of diethylene glycol (DEG) as a solvent, and then named the preparation ” Elixir Sulfanilamide”. Although it was widely known that DEG was lethally poisonous to humans, Watkins was not aware of this. He did not perform any testing of the Elixir and had it sent out for sale and distribution to the consumer. The results were devastating and caused the public to demand that the government take stronger actions to prevent urther harm.

On June, 25th 1 938, approximately six months after the Elixir Sulfanilamide incident, Congress altered food and drug law by enacting the Food, Drug and Cosmetic Act, which required the FDA to certify the safety of all new drugs before they are put on the market. The FD established stronger national regulations and testing standards to improve the quality and purity of food and drug products being sold within the United States. Its primary objective had been to ensure the safety of the public, and it has been the foundation of the U. S. food and drug product safety standards for more han 70 years.

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