THE ANIMAL RULEEmily Yang and Sana Ahmad

HOW IT CAME TO BEE

It was finalized by the FDA and authorized by the US Congress in 2002 following the 9/11 attacks and concerns regarding bioterrorism

NO, IT ISN’T A NEW WORLD ORDER WHERE HAMSTERS ARE PRESIDENT.

Before a product can be FDA approved, it must prove

efficacy. It must

work.

“But what if something has a low incidence/prevalance?”

You would have to challenge people with the illness in order to see if the proposed therapy works

This isn’t always ethical and/or possible

WHAT IT IS

An allowance by the FDA to “bypass” human testing on the path to approval when human efficacy studies are not ethical and field trials to study effectiveness of the drug are not feasible.

THE CATERIA

The FDA will rely on evidence from animal studies to provide substantial evidence of effectiveness

only when all of the following criteria are met:

ONE

There is a reasonably well understood pathophysiological mechanism of the toxicity of the substance and its prevention or substantial reduction by the product;

TWO

The effect is demonstrated in more than one animal species expected to react with a response predictive for humans, unless the effect is demonstrated in a single animal species that represents a sufficiently well characterized animal model for predicting to the response in humans;

THREE

The animal study endpoint is clearly related to the desired benefit in humans, general the enhancement of survival or prevention of major morbidity; and

FOUR

The data or information on the kinetics and pharmacodynamics of the product or other relevant data or information in animals and humans, allows selection of an effective dose in humans

A RELEPHANT CASE

The Ebola Virus infection is highly lethal with no effective

therapies or treatments.

Because outbreaks occur unpredictable and

sporadically, vaccine efficacy cannot be

proven in human trials

(which are required for FDA approval)

The animal rule allows laboratory animal data to

be used to show Efficacy when human trials are

not logically feasible.

RESOURCES

"U.S. Food and Drug Administration." Animal Rule Information. N.p., n.d. Web. 10 June 2016.

Snoy, P. J. "Establishing Efficacy of Human Products Using Animals The US Food and Drug Administration’s “Animal Rule”." Veterinary Pathology Online 47.5 (2010): 774-778.

Sullivan, Nancy J., et al. "Correlates of protective immunity for Ebola vaccines: implications for regulatory approval by the animal rule." Nature Reviews Microbiology 7.5 (2009): 393-400.

Allio, T. "Product Development Under FDAs Animal Rule: Understanding FDAs Expectations and Potential Implications for Traditional Development Programs." Therapeutic Innovation & Regulatory Science(2016): n. pag. FDA. Web. 1 June 2016.