The Biologics Control Act was passed in the United States on July 1, 1902 after two incidents involving the deaths of children caused by contaminated vaccines.
History
In 1887, the United States first bacteriological laboratory was established by Joseph Kinyoun at the Marine Health Service Hospital at Staten Island, New York. In 1891, the Laboratory of Hygiene was relocated to Washington, D.C. The Hygienic Laboratory developed procedures for diphtheria antitoxin and provided licensing for biological manufacturers. The Biologics Control Act mandated producers in the United States to be licensed annually for the manufacture and sale of antitoxins, serum, and vaccines.
In 1930, the Hygienic Laboratory was titled the National Institute of Health. In 1937, the Division of Biologics Control was formed within the National Institute of Health. In 1972, the Division of Biologics was transferred from National Institute of Health to the U.S. Food and Drug Administration and renamed the Bureau of Biologics.
In 1988, the Bureau of Biologics was transferred to the Center for Biologics Evaluation and Research (CBER), which is a national biologics center within the U.S. Food and Drug Administration.
Although it was signed with much less fanfare than the Pure Food and Drug Act, the Biologics control act set a precedent for federal regulation of biological products.
Adverse Effects
In 1901, the first incident involved the horse named Jim whose tetanus-contaminated serum was used to produce a diphtheria antitoxin that caused the deaths of thirteen children in St. Louis, Missouri.
The second incident involved contaminated smallpox vaccine which killed nine children in Camden, New Jersey. Both incidents were attributed to failure of proper procedures and testing by local officials.
References
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