The U.S. Food and Drug Administration (FDA) is responsible for
ensuring the safety, effectiveness, and quality of pharmaceuticals,
biologicals, and medical devices intended for human use as well as the safety
of food, cosmetics, and radiation-emitting products. In addition, this agency
is responsible for the safety, efficacy, and quality of pharmaceuticals and
feed intended for animal use.
The FDA's Center for Food Safety and Applied Nutrition (CFSAN)
regulates food and food additives sold in the United States. CFSAN's Redbook 2000 is a manual of test methods that the agency
expects will be performed for novel food additives or ingredients. These tests
include the use of many animals and multiple species; some typically involve
dogs (or puppies) and, in some cases, last one year.
CFSAN also requires the monitoring of shellfish for algal toxins
that accumulate in their flesh and can cause health problems in humans. For
decades, this monitoring meant injecting liquefied shellfish into the abdominal
cavities of mice—an excruciating process that causes convulsions,
severe pain, paralysis, and, ultimately, death when a shellfish is
PETA U.S. and PETA U.K. have
worked closely with both the European Commission and the FDA to replace this test for all types of shellfish hazards.
The marketing of drugs and other pharmaceutical products in the
U.S. is controlled by the Federal Food, Drug, and Cosmetic Act, which empowers the
FDA's Center for Drug Evaluation and Research to require extensive toxicity
testing on animals before a new drug is deemed "safe" for marketing.
In order to satisfy FDA data requirements, thousands of rats,
mice, rabbits, dogs, and primates are killed in "preclinical"
laboratory poisoning experiments to assess the safety of new drugs (including
all ingredients and even minor differences in formulation). Commonly required animal tests include the following:
Following this extensive battery of animal testing, drugs
generally undergo three phases of clinical trials before they are considered
for widespread human use. The fact that months or years of human studies are
required over and above the standard battery of animal tests suggests that
health authorities do not trust the results of animal experiments—and for good
reason. A significant number of drugs are rejected during human clinical trials
because they are found to cause toxic and other adverse health effects
"not predicted" in preclinical animal experiments.
In fact, the FDA
reported  that
92 out of every 100 drugs that successfully pass animal trials and go into
human clinical testing fail during the human clinical
The problem is that species differences are so vast that animal
results are, at best, a very poor approximation of what will happen in humans
or, at worst, dangerously misleading. The alternative is to advance science to
the point where preclinical tests are based on human biology, which will better
predict what will happen to real human volunteers or patients in the clinical
Today, cutting-edge technologies, such as
biochip, which features microfluidic circuits lined with
cells from various human organs, can allow us to better predict complex human
 FDA Teleconference: "Steps to Advance the Earliest Phases of Clinical Research in the Development of Innovative Medical Treatments" (von Eschenbach, Andrew C. 2006).
"Biologicals" are medicinal products, such as vaccines,
hormones, antibodies, and blood products, that are derived from living
organisms. In the U.S., biologicals are regulated by the FDA's Center for
Biologics Evaluation and Research. Because of their origin, biologicals must
undergo extensive quality control during production.
Vaccine testing in particular consumes an estimated 2.5 million animals
every year because vaccines are often produced by weakening, inactivating, or
detoxifying a virulent microorganism or toxin. Each batch of the finished
product is then tested on animals, causing them pain, suffering, and death.
Safety testing is carried out to try to make sure that a safe
immune response is observed and that people who are inoculated with the vaccine
are not infected by the pathogen. A common study is the "abnormal toxicity
test," in which guinea pigs and mice are injected with a biological
product and observed for one week. The test may be repeated multiple times for
the same product until all of the following criteria are met:
Numerous other disease-specific animal safety tests have also been
developed, such as the "mouse weight-gain test," which is used for
the whole-cell pertussis vaccine. In this test, mice injected with the vaccine
are observed for weight gain and to see whether they are alive or dead after 72
hours and again after one week.
Another test, for the oral polio vaccine, called the
"neurovirulence test," is also devastating to animals. In this test,
rhesus or cynomolgus monkeys receive an injection of the vaccine in their
spines, are observed for up to three weeks for signs of paralysis, and are then
killed and examined.
"Potency testing" is carried out to determine the
effectiveness of inactivated (nonliving) vaccines in protecting the recipient
against bacterial or viral infections. These studies use "challenge"
tests, in which large numbers of animals—usually mice, rats, guinea pigs, rabbits, and/or chickens—are inoculated with a vaccine and then "challenged"
through purposeful infection with the disease that the vaccine is designed to
To test the potency of a single batch of rabies vaccine, for
example, live rabies virus is injected through the skulls and directly into the
brains of 160 mice. Some of these mice are given the protective vaccine first,
but some are not. These cranial injections are extremely painful and completely
irrelevant to the normal route of infection. Approximately half of the animals
develop and/or die of rabies, a painful neurological disease involving tremors,
loss of control over one's body, the inability to swallow, and severe weight
loss. Analytical methods have been developed by rabies vaccine manufacturers,
but they are not yet validated or accepted for regulatory use. Until
validation, countless animals will continue to die painful deaths in accordance
with FDA and USDA guidance.
The FDA's Center for Devices and Radiological Health is
responsible for the licensing of medical devices, which include an extremely
broad range of products, such as cardiac pacemakers, stents, insulin pumps, and
A great deal of animal testing for these products relates to the
safety of the materials in the medical devices: the plastic polymers, the
metals, and the ceramics. These materials are implanted into an animal's
tissues, or chemicals leached from these products are injected into their
tissues to observe the toxicity to animals. Researchers are generally looking
for toxicity to cells and allergic potential, as well as applying the acute and
chronic toxicity tests described above (in the "Drugs" section).
These "biocompatibility tests" (click here and here for more information) are often conducted on mice and rats. Similar
to what is done with biologics, each batch of a medical device is also tested
for quality control using animals.
Testing the effectiveness of medical devices is often difficult
because these devices are specifically designed for human anatomy and
physiology. Pigs, sheep, and dogs are the most commonly used species for
efficacy testing of these devices, even though the structure of the animals'
bodies is often too dissimilar to be of use.
Physicians and medical device sales specialists also use animals
(primarily dogs and pigs) during training exercises in which the animals are
often implanted with the device and later killed.
Alternatives include human cadavers, bench-top simulators of
various human organs, cell-based tests, and computer programs that can
simulate, for example, the effect of a particular heart rhythm as encoded into
Almost all of us grew up eating meat, wearing leather, and going to circuses and zoos. We never considered the impact of these actions on the animals involved. For whatever reason, you are now asking the question: Why should animals have rights? Read more.