Biologics Control Act
Encyclopedia
The Biologics Control Act was passed in the United States on July 1, 1902 after two incidents involving the death
s of children caused by contaminated vaccine
s. The first 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 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. The act established the Center for Biologics Evaluation and Research
(CBER), which was placed under the authority of the NIH by the Public Health Service Act
of 1944, and became one of the centers of the Food and Drug Administration
(FDA) in 1972. 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.
Death
Death is the permanent termination of the biological functions that sustain a living organism. Phenomena which commonly bring about death include old age, predation, malnutrition, disease, and accidents or trauma resulting in terminal injury....
s of children caused by contaminated vaccine
Vaccine
A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe or its toxins...
s. The first involved the horse named Jim
The horse named Jim
Jim was a former milk wagon horse who was used to produce serum containing antibodies against diphtheria toxin. Jim produced over 30 quarts of diphtheria antitoxin in his career, and no doubt saved many lives. However, on October 2, 1901 Jim showed signs that he had contracted tetanus and was...
whose tetanus
Clostridium tetani
Clostridium tetani is a rod-shaped, anaerobic bacterium of the genus Clostridium. Like other Clostridium species, it is Gram-positive, and its appearance on a gram stain resembles tennis rackets or drumsticks. C. tetani is found as spores in soil or in the gastrointestinal tract of animals. C...
-contaminated serum
Blood plasma
Blood plasma is the straw-colored liquid component of blood in which the blood cells in whole blood are normally suspended. It makes up about 55% of the total blood volume. It is the intravascular fluid part of extracellular fluid...
was used to produce a diphtheria
Diphtheria
Diphtheria is an upper respiratory tract illness caused by Corynebacterium diphtheriae, a facultative anaerobic, Gram-positive bacterium. It is characterized by sore throat, low fever, and an adherent membrane on the tonsils, pharynx, and/or nasal cavity...
antitoxin
Antitoxin
An antitoxin is an antibody with the ability to neutralize a specific toxin. Antitoxins are produced by certain animals, plants, and bacteria. Although they are most effective in neutralizing toxins, they can kill bacteria and other microorganisms. Antitoxins are made within organisms, but can be...
that caused the deaths of thirteen children in St. Louis, Missouri. The second involved contaminated smallpox
Smallpox
Smallpox was an infectious disease unique to humans, caused by either of two virus variants, Variola major and Variola minor. The disease is also known by the Latin names Variola or Variola vera, which is a derivative of the Latin varius, meaning "spotted", or varus, meaning "pimple"...
vaccine which killed nine children in Camden, New Jersey. Both incidents were attributed to failure of proper procedures and testing by local officials. The act established the Center for Biologics Evaluation and Research
Center for Biologics Evaluation and Research
The Center for Biologics Evaluation and Research is one of six main centers for the U.S. Food and Drug Administration , which is a part of the U.S. Department of Health and Human Services. The current Director of CBER is Dr. Karen Midthun, M.D...
(CBER), which was placed under the authority of the NIH by the Public Health Service Act
Public Health Service Act
The Public Health Service Act is a United States federal law enacted in 1944. The full act is captured under Title 42 of the United States Code "The Public Health and Welfare", Chapter 6A "Public Health Service"....
of 1944, and became one of the centers of the Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA) in 1972. Although it was signed with much less fanfare than the Pure Food and Drug Act
Pure Food and Drug Act
The Pure Food and Drug Act of June 30, 1906, is a United States federal law that provided federal inspection of meat products and forbade the manufacture, sale, or transportation of adulterated food products and poisonous patent medicines...
, the Biologics control act set a precedent for federal regulation of biological products.