Biologics Control Act of 1902

The Biologics Control Act of 1902 is a landmark piece of U.S. legislation that laid the foundation for federal regulation of biological products such as vaccines, blood products, and antitoxins. It was one of the first laws in the world aimed at ensuring the safety, purity, and potency of biologic medicines.

Background:

The act was passed in response to two deadly incidents involving contaminated biological products:

1. 1901 St. Louis Incident: Thirteen children died after receiving diphtheria antitoxin that was contaminated with tetanus

2. 1901 Camden, New Jersey Incident: Nine children died after receiving a contaminated smallpox vaccine

These tragedies revealed the dangers of unregulated biological manufacturing and triggered public outcry.

Key Provisions of the Act:

The Biologics Control Act of 1902:

• Established federal oversight of the manufacturing of biological products

• Required licensing of manufacturers and facilities producing biologics

• Mandated that biologics be produced under strict hygienic conditions to ensure safety and purity

• Created penalties for non-compliance, including fines and imprisonment

• Allowed the U.S. government to inspect facilities, test products, and enforce standards

Implementation and Oversight:

• The law was initially enforced by the Laboratory of Hygiene, which later became part of the National Institutes of Health (NIH)

• This oversight laid the groundwork for the creation of what is now the Center for Biologics Evaluation and Research (CBER) within the U.S. Food and Drug Administration (FDA)

Long-Term Significance:

• First major U.S. law regulating medical products based on safety

• Preceded the Pure Food and Drug Act (1906) and the Federal Food, Drug, and Cosmetic Act (1938)

• Set the precedent for modern biologic regulation, including today’s vaccines, gene therapies, and monoclonal antibodies