There are a lot of myths circulated by animal rights activists about the use of animals in biomedical research, which they are opposed to, even when such research benefits the animals themselves.

Most scientists and researchers understand that biomedical progress usually requires studies in animals to prove that vaccines, medications, and medical devices are safe and efficacious before they will be approved by FDA or USDA (USDA approves vaccines used to protect animal health).

FDA’s Guidance for Industry and Reviewers for Exploratory Investigational New Drug (IND) Studies explains why animal testing is required:

“Before the human studies can begin, an IND must be submitted to the Agency containing, among other things, information on any risks anticipated based on the results of pharmacologic and toxicological data collected during studies of the drug in animals (21 CFR 312.23(a)(8)). These basic safety tests are most often performed in rats and dogs. The studies are designed to permit the selection of a safe starting dose for humans, to gain an understanding of which organs may be the targets of toxicity, to estimate the margin of safety between a clinical and a toxic dose, and to predict pharmacokinetic and pharmacodynamic parameters.”

The Center for Veterinary Medicine at FDA provides guidance for new animal drug approval:

“New animal drugs are approved for specific intended uses (indications). To get a drug approved for a new indication, a sponsor submits a new animal drug application (NADA).”

The following information that must be submitted to support an NADA, usually requires animal testing.

  • Effectiveness
  • Chemistry, manufacturing, and controls
  • Safety to the target species
  • Environmental Assessment
  • Human food safety
  • Freedom of Information (FOI) Summary (food-producing animal species), and
  • Labeling

“The target animal safety section may include studies which identify the toxic syndrome(s) associated with the drug and the margin of safety of use of the product in the treated animal. The human food safety section may include short and long term toxicology studies, total residue and metabolism studies, analytical method validation studies, and tissue residue depletion studies.”

The American Association for Laboratory Animal Science (AALAS), an association of professionals that advances responsible laboratory animal care and use to benefit people and animals, describes the regulatory oversight of laboratory facilities:

“Laboratory facilities containing animals must meet strict federal, state and local requirements. Federal regulators routinely inspect laboratories to ensure that animals are adequately housed and cared for. Additionally, many laboratories submit to additional voluntary inspection for accreditation through the Association for the Assessment and Accreditation of Laboratory Animal Care, International (AAALAC).”

“Further, each institution must establish an animal care and use committee [an Institutional Animal Care and Use Committee (IACUC)] that includes an outside member of the public and a veterinarian. This committee oversees, inspects and monitors every potential study to ensure optimal animal care.”

The Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC), a private, nonprofit organization, promotes the humane treatment of animals in science through voluntary accreditation and assessment programs.

“More than 900 companies, universities, hospitals, government agencies and other research institutions in 39 countries have earned AAALAC accreditation, demonstrating their commitment to responsible animal care and use. These institutions volunteer to participate in AAALAC’s program, in addition to complying with the local, state and federal laws that regulate animal research.”

The IACUC, veterinarians, laboratory technicians, and researchers insure that the highest quality of animal care and treatment is provided to the animals they work with to provide the vital information required for the development and approval of life-saving drugs, vaccines, and medical devices.

As AALAS explains, the scientific community advocates highest quality of animal care the for two key reasons.

“First, working with animals in research is a privilege, and those animals helping us unlock the mysteries of disease deserve our respect and compassion. Second, only healthy animals are reliable models for the study of disease.”

Biomedical research remains vitally important to continue the amazing advancements in human and veterinary medicine that have saved hundreds of thousands of lives. The scientists and researchers on the front lines, and the animals they work with, should be respected and honored for their work.