the animal rule
TRANSCRIPT
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.