The

FDA 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 ...

animal efficacy rule (also known as animal rule) applies to

development Development or developing may refer to: Arts *Development (music), the process by which thematic material is reshaped * Photographic development *Filmmaking, development phase, including finance and budgeting * Development hell, when a proje ...

and testing of

drug A drug is any chemical substance other than a nutrient or an essential dietary ingredient, which, when administered to a living organism, produces a biological effect. Consumption of drugs can be via insufflation (medicine), inhalation, drug i ...

s and biologicals to reduce or prevent serious or life-threatening conditions caused by exposure to lethal or permanently disabling toxic agents (

chemical A chemical substance is a unique form of matter with constant chemical composition and characteristic properties. Chemical substances may take the form of a single element or chemical compounds. If two or more chemical substances can be combin ...

biological Biology is the scientific study of life and living organisms. It is a broad natural science that encompasses a wide range of fields and unifying principles that explain the structure, function, growth, origin, evolution, and distribution of ...

radiological In physics, radiation is the emission or transmission of energy in the form of waves or particles through space or a material medium. This includes: * ''electromagnetic radiation'' consisting of photons, such as radio waves, microwaves, infr ...

, or nuclear substances), where human efficacy trials are not feasible or

ethical Ethics is the philosophical study of moral phenomena. Also called moral philosophy, it investigates normative questions about what people ought to do or which behavior is morally right. Its main branches include normative ethics, applied e ...

. The animal efficacy rule was finalized by the FDA and authorized by the

United States Congress The United States Congress is the legislature, legislative branch of the federal government of the United States. It is a Bicameralism, bicameral legislature, including a Lower house, lower body, the United States House of Representatives, ...

in 2002, following the

September 11 attacks The September 11 attacks, also known as 9/11, were four coordinated Islamist terrorist suicide attacks by al-Qaeda against the United States in 2001. Nineteen terrorists hijacked four commercial airliners, crashing the first two into ...

and concerns regarding

bioterrorism Bioterrorism is terrorism involving the intentional release or dissemination of biological agents. These agents include bacteria, viruses, insects, fungi, and/or their toxins, and may be in a naturally occurring or a human-modified form, in mu ...

Summary

The FDA can rely on evidence from

animal studies Animal studies is a recently recognised field in which animals are studied in a variety of cross-disciplinary ways. Scholars who engage in animal studies may be formally trained in a number of diverse fields, including art history, anthropology ...

to provide substantial evidence of product effectiveness if: # There is a reasonably well-understood mechanism for the

toxicity Toxicity is the degree to which a chemical substance or a particular mixture of substances can damage an organism. Toxicity can refer to the effect on a whole organism, such as an animal, bacteria, bacterium, or plant, as well as the effect o ...

of the agent and its amelioration or prevention by the product; # The effect is demonstrated in either: ## More than one animal species expected to react with a response predictive for humans; or ## One well-characterized animal species model (adequately evaluated for its responsiveness in humans) for predicting the response in humans. # The animal study endpoint is clearly related to the desired benefit in humans; and # Data or information on the

pharmacokinetics Pharmacokinetics (from Ancient Greek ''pharmakon'' "drug" and ''kinetikos'' "moving, putting in motion"; see chemical kinetics), sometimes abbreviated as PK, is a branch of pharmacology dedicated to describing how the body affects a specific su ...

and

pharmacodynamics Pharmacodynamics (PD) is the study of the biochemistry, biochemical and physiology, physiologic effects of drugs (especially pharmaceutical drugs). The effects can include those manifested within animals (including humans), microorganisms, or comb ...

of the product or other relevant data or information in animals or humans is sufficiently well understood to allow selection of an effective dose in humans, and it is, therefore, reasonable to expect the effectiveness of the product in animals to be a reliable indicator of its effectiveness in humans. FDA published a ''Guidance for Industry'' on the Animal Rule in October 2015.

References

External links

21 CFR Parts 314 and 601, Docket No. 98N-0237
New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible.

FDA.gov Postmarketing Requirements and Commitments: Frequently Asked Questions (FAQ) {{U.S. biological defense Animal testing Biological warfare Biological contamination Bioethics Biotechnology products Biotechnology Life sciences industry Pharmaceutical industry Pharmacy Specialty drugs