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Interestingly, the first commercial producer of the diphtheria antitoxin, H. K. Mulford,
had already adopted strategies to minimize the occurrence of tragic situations akin to the one in
St. Louis. For the first two years of its antitoxin production, 1895–1897, Mulford sent every
batch of antitoxin to the University of Pennsylvania’s Laboratory of Hygiene for testing.13 The
company advertised that it dated and labeled all its merchandise and that it invited medical
professionals to inspect its facilities to ensure the highest-quality merchandise.14 Despite these
precautions, however, the smallpox vaccine in Camden that was contaminated with tetanus is
thought to have come from Mulford, although authorities never confirmed the source of
contamination.15
The Biologics Control Act of 1902, which was passed in response to the two vaccinerelated tragedies of the previous year, required licensing for the production of all antitoxins and
vaccines, as well as the labeling of all products with the product name, license number, and
expiration date. The act vested the secretary of the Treasury with licensing authority and created
a board comprising the secretaries general of the US Army, Navy, and Marine hospitals.16 The
board was charged with developing regulatory standards for licensing as well as for the sale of
antitoxins, serums, and other products. In 1903, the Hygienic Laboratory of the Public Health
issued the first regulations promulgated under the law.17
13
Louis Galambos and Jane Eliot Sewell, Networks of Innovation: Vaccine Development at Merck, Sharp and
Dohme, and Mulford, 1895–1995 (Cambridge, UK: Cambridge University Press, 1997), 17n21.
14
Ibid., 18.
15
David E. Lilienfeld, “The First Pharmacoepidemiologic Investigations: National Drug Safety Policy in the United
States, 1901–1902,” Perspectives in Biology and Medicine 51, no. 2 (2008): 188–98, 193.
16
“1902 Biologics Control Act,” US Pharmocopeia, October 7, 2010.
17
Center for Biologics Evolution and Research (CBER), “Science and the Regulation of Biological Products,” Food
and Drug Administration, September 2002, 13.
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