Biologics Control Act

Biologics Control Act of 1902

Long title	An Act to regulate the sale of viruses, serums, toxins, and analogous products in the District of Columbia; to regulate interstate traffic in said articles, and for other purposes.
Nicknames	Virus-Toxin Law
Enacted by	the 57th United States Congress
Effective	July 1, 1902
Citations
Public law	57-244
Statutes at Large	32 Stat. 728, Chapter 1378
Legislative history
Signed into law by President Theodore Roosevelt on July 1, 1902

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.^[1]

History

The Marine Hospital, Staten Island, N.Y. In 1887, National Institute of Health began as a single room Laboratory of Hygiene for bacteriological investigation established by the U.S. Marine Hospital Service at Stapleton, Staten Island, New York. From 1887 to 1891, the Laboratory was located in the attic of the Marine Hospital on Staten Island.

In 1887, the United States first bacteriological laboratory was established by Joseph Kinyoun at the Marine Health Service Hospital at Staten Island, New York.^[2] 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.^[3]

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.^[4]

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.^[5]

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.^[6]

References

1. "Biologics: A Short History of the National Institutes of Health". Office of National Institutes of Health History. May 16, 2010.
2. "Birth of the Hygienic Laboratory". Origins of the National Institutes of Health. U.S. National Library of Medicine. May 8, 1987.
3. "The Road to the Biotech Revolution - Highlights of 100 Years of Biologics Regulation". FDA Consumer magazine The Centennial Edition / January-February 2006. U.S. Food and Drug Administration. January 19, 2012.
4. "Science and the Regulation of Biological Products". U.S. Food and Drug Administration. April 9, 2009.
5. "The St. Louis Tragedy and Enactment of the 1902 Biologics Control Act". U.S. Food and Drug Administration. April 9, 2009.
6. Junod, Ph.D., Suzanne White (May 21, 2009). "Biologics Centennial: 100 Years of Biologics Regulation". U.S. Food and Drug Administration.