Page 122 - Veterinary Toxicology, Basic and Clinical Principles, 3rd Edition

VetBooks.ir Chapter 6

Regulatory Considerations in Veterinary

Toxicology: An FDA Perspective

Susan J. Bright-Ponte, Tong Zhou and Michael J. Murphy

INTRODUCTION solvent (diethylene glycol). The new Federal Food, Drug,
and Cosmetic Act (FFDCA, the Act) was signed into law
Brief History of the Food and Drug by President Franklin D. Roosevelt in 1938. This law sig-
Administration nificantly increased regulatory authority over drugs by
mandating a premarket review of the safety of all new
The US Food and Drug Administration (FDA) is a regula-
drugs, as well as banning false therapeutic claims in drug
tory, science-based federal agency responsible for protect-
labeling. The law also authorized inspections of factories
ing and promoting the public health through the
and expanded enforcement powers, set new regulatory
monitoring and regulation of many products necessary for
standards for foods, and brought cosmetics and therapeu-
the health and well-being of consumers. The FDA’s juris-
tic devices under federal regulatory authority. In 1940,
diction includes most food products (other than meat,
the FDA was transferred from the USDA to a department
poultry, and some egg products), animal food, human and
that would ultimately become today’s Department of
animal drugs, medical devices, veterinary devices, thera-
Health and Human Services (FDA, 2012a).
peutic agents of biologic origin (e.g., vaccines, blood, and
In 1962, the Kefauver-Harris Amendment to the
blood products) for humans, radiation-emitting products
FFDCA was passed, requiring that a new drug must also
for consumer, medical and occupational use, cosmetics,
demonstrate substantial evidence of efficacy for its spe-
and tobacco products. The history of the FDA can be
cific indication, in addition to the requirement for premar-
traced back to the latter part of the 19th century, when
ket demonstration of safety. Drugs approved between
Harvey Washington Wiley, chief chemist of the
1938 and 1962 were also subject to an FDA review of
US Department of Agriculture (USDA) Division of
efficacy. The 1962 amendments also placed some restric-
Chemistry (later the Bureau of Chemistry), began con-
tions on drug advertising and expanded the FDA’s author-
ducting research into the misbranding and adulteration of
ity to inspect drug-manufacturing facilities (FDA, 2009b).
food and drug products in US commerce. Wiley published
In 1968, Congress passed legislation to strengthen pro-
the Division’s findings and lobbied for new federal laws
visions of the Act that pertained to regulation of animal
to set uniform standards for food and drugs entering into
drugs. The Animal Drugs Amendments of 1968 required
interstate commerce, resulting in the passage of the Food
that animal drugs, medicated feeds, and food additives be
and Drugs Act in 1906 (FDA, 2015a). The Food and
safe for the animal for which they were intended for use
Drugs Act prohibited the interstate transport of adulter-
as well as for food-producing animals (that they are safe
ated or misbranded food, drink and drugs, and was first
for human consumption), and safe for the environment.
administered by the USDA’s Bureau of Chemistry (FDA,
Effectiveness studies were also required (FDA, 2010a).
2009a). The Bureau of Chemistry’s regulatory powers
A comprehensive history of the FDA’s regulatory
were later reorganized under a new USDA body, the
functions can be found on the FDA’s website (FDA,
Food, Drug, and Insecticide Organization, which was
2015a). A number of amendments have been made to the
eventually renamed the FDA. The Food and Drugs Act of
FFDCA related to various areas of FDA regulatory
1906 was ultimately replaced by broader legislation, in
responsibility. Information about significant amendments
light of the “Elixir Sulfanilamide” tragedy, in which over
is available on the FDA’s website (FDA, 2015b).
100 people died after using a drug formulated with a toxic
Veterinary Toxicology. DOI: http://dx.doi.org/10.1016/B978-0-12-811410-0.00006-4
2018 Published by Elsevier Inc. 89