Biologics Control Act

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. 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.

References

* [http://www.fda.gov/fdac/features/2002/402_bio.html] - A brief review of major accomplishments during the first 100 years of CBER
* [http://www.fda.gov/oc/history/makinghistory/100yearsofbiologics.html] - An overview of the incident and conditions surrounding it