The Biologics Control Act of 1902

By 1895 diphtheria antitoxin was being made from horse serum in the United States, first by the New York City Board of Health and the Hygienic Laboratory of the Marine Hospital Service and soon by commercial firms that also sold smallpox vaccine, among them Parke, Davis and Co. and Mulford. Local makers worked without any central or uniform controls.

In St. Louis the Board of Health drew serum from a retired milk-wagon horse named Jim that had tetanus. By late 1901, 13 children given the diphtheria antitoxin made from it had died of tetanus. That same year nine children in Camden, New Jersey, died of tetanus after receiving contaminated smallpox vaccine. Both disasters drew wide public attention.

Congress answered with the Biologics Control Act, also called the Virus-Toxin Law, which became law on 1 July 1902. It gave the government its first control over the processes used to make biological products. Regulations effective on 21 August 1903 required makers of vaccines, serums and antitoxins to hold a license renewed every year, to open their plants to inspection and to work under a qualified scientist, and licenses could be suspended or revoked. Labels had to give the product's name, an expiration date, and the maker's address and license number. The Secretary of the Treasury issued the licenses, foreign makers could apply, and by 1903 thirteen had been granted, two of them to organizations in France and Germany. Licenses 1 and 2 went to Parke, Davis of Detroit and H. K. Mulford of Philadelphia.

The Federal Food and Drugs Act of 1906 made no mention of biological products. After the Food, Drug, and Cosmetic Act of 1938, provisions of both the 1902 and 1938 laws were used to regulate them. In 2002 the FDA's Center for Biologics Evaluation and Research marked 100 years of biologics regulation with a symposium and an exhibit at the Smithsonian's National Museum of American History.