The Biologics Control Act of 1902, also known as the Virus-Toxin Law, was the first law that implemented federal regulations of
biological products such as
vaccine
A vaccine is a biological Dosage form, preparation that provides active acquired immunity to a particular infectious disease, infectious or cancer, malignant disease. The safety and effectiveness of vaccines has been widely studied and verifie ...
s in the United States. It was enacted in response to two incidents involving the deaths of 22 children who had contracted
tetanus
Tetanus, also known as lockjaw, is a bacterial infection caused by ''Clostridium tetani'', and is characterized by muscle spasms. In the most common type, the spasms begin in the jaw and then progress to the rest of the body. Each spasm usually ...
from contaminated
vaccine
A vaccine is a biological Dosage form, preparation that provides active acquired immunity to a particular infectious disease, infectious or cancer, malignant disease. The safety and effectiveness of vaccines has been widely studied and verifie ...
s.
This law paved the way for further regulation of drug products under the
Pure Food and Drug Act
The Pure Food and Drug Act of 1906, also known as Dr. Wiley's Law, was the first of a series of significant consumer protection laws which was enacted by Congress in the 20th century and led to the creation of the Food and Drug Administration. ...
of 1906 and the
Federal Food, Drug, and Cosmetic Act
The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of f ...
of 1938. Biologics control is now under the supervision of the
U.S. Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food s ...
(FDA).
History
![Marine Hospital Service Stapleton Staten Island 19thcentury](https://upload.wikimedia.org/wikipedia/commons/a/a5/Marine_Hospital_Service_Stapleton_Staten_Island_19thcentury.gif)
When the large scale production of vaccines and anti-toxin serum began in the late 19th century, the United States had no government regulations on biological products.
In 1901, a 5-year-old girl died of tetanus in St. Louis, Missouri, after being given a
diphtheria anti-toxin. Investigations found that the St. Louis Board of Health produced the contaminated anti-toxin using the blood of a horse infected with tetanus. While the infected horse,
Jim
Jim or JIM may refer to:
* Jim (given name), a given name
* Jim, a diminutive form of the given name James
* Jim, a short form of the given name Jimmy
* OPCW-UN Joint Investigative Mechanism
* ''Jim'' (comics), a series by Jim Woodring
* ''Jim ...
, was killed, the Board of Health continued to use the serum to treat diphtheria. It was later discovered that 12 other children had died from the same contaminated anti-toxin serum in St. Louis. That same year, nine children in
Camden, New Jersey
Camden is a city in and the county seat of Camden County, in the U.S. state of New Jersey. Camden is part of the Delaware Valley metropolitan area and is located directly across the Delaware River from Philadelphia, Pennsylvania. At the 2020 ...
, died from contaminated smallpox vaccines. These incidents led the Hygienic Laboratory and the Medical Society of the District of Columbia to propose a law regulating the production of biological products. On July 1, 1902, Congress passed the Biologics Control Act.
Contents of the Act
The Biologics Control Act established a board to oversee the implementation of regulations of biological products. The board consisted of the Surgeon-General of the Army, the Surgeon-General of the Navy, and the Surgeon-General of the Marine Hospital Service, and was to be overseen by the Secretary of the Treasury. This board was given the power to issue, suspend, and revoke licenses to produce and sell biological products. The Biologics Control Act also mandated that all products be labeled accurately with the name of the product and the address and license number of the manufacturer.
Laboratories could be subjected to unannounced inspections by the Treasury Department. The punishment for the violation of this law was a fine of up to $500 or up to a year in prison.
Institutions
The Laboratory of Hygiene of the
Marine Hospital Service
The Marine Hospital Service was an organization of Marine Hospitals dedicated to the care of ill and disabled seamen in the United States Merchant Marine, the U.S. Coast Guard and other federal beneficiaries. The Marine Hospital Service evolved ...
, established on Staten Island, NY, in 1887, was in charge of testing biologics before the Biologics Control Act. It was moved to Washington, D.C., in 1891, and renamed the Hygienic Laboratory of the Public Health and Marine Hospital Service in 1902.
The Hygienic Laboratory was responsible for renewing licenses annually, testing products, and performing inspections. In 1930, the
Ransdell Act
The Ransdell Act (ch. 251, , codified as amended at , , ), reorganized, expanded and redesignated the ''Laboratory of Hygiene'' (created in 1887) as the National Institute of Health.
Congress appropriated $750,000 in the bill for construction of ...
transformed the Hygienic Laboratory into the National Institute of Health and gave it a larger role in public health research. In 1948, the name was changed again to the
National Institutes of Health
The National Institutes of Health, commonly referred to as NIH (with each letter pronounced individually), is the primary agency of the United States government responsible for biomedical and public health research. It was founded in the late ...
, as it encompassed many institutes and centers dedicated to biomedical research. In 1972, biologics regulation was moved to the
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
and later became known as the
Center for Biologics Evaluation and Research (CBER).
Impact
The Biologics Control Act set a precedent for the federal regulation of biologics such as vaccines and blood components.
With the development of biotechnology, the FDA's
Center for Biologics Evaluation and Research (CBER) has taken a larger role in reviewing and approving new biological products intended for medical purposes, including
probiotic
Probiotics are live microorganisms promoted with claims that they provide health benefits when consumed, generally by improving or restoring the gut microbiota. Probiotics are considered generally safe to consume, but may cause bacteria-host i ...
s,
xenotransplantation
Xenotransplantation (''xenos-'' from the Greek meaning "foreign" or strange), or heterologous transplant, is the transplantation of living cells, tissues or organs from one species to another. Such cells, tissues or organs are called xenograft ...
and
gene therapy
Gene therapy is a medical field which focuses on the genetic modification of cells to produce a therapeutic effect or the treatment of disease by repairing or reconstructing defective genetic material. The first attempt at modifying human DN ...
.
[{{Cite web, url=https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/, title=About the Center for Biologics Evaluation and Research (CBER), last=Research, first=Center for Biologics Evaluation and, website=www.fda.gov, language=en, access-date=2017-05-05]
References
57th United States Congress
Vaccination law
United States federal health legislation
1902 in American law
Drug safety
Biotechnology law
Vaccination in the United States