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Institutions, Réglementation

31 - 12 - 2014

The Animal Rule, an American exception

Faced with the recent crisis of the Ebola virus, the FDA (a US agency for Food and Drug Administration) has set up the Animal Rule. This is an exception that allows the approval of a drug or a vaccine tested only in animals, if human-testing is infeasible, as is the case with incurable and fatal diseases such as Ebola.

 

Epidémie Ebola

 

The role of the FDA

 

The FDA, which stands for Food and Drug Administration, is a US government agency responsible for pharmacovigilance – the study, control and regulation of drugs.

 

Thus, this agency has the power to authorize or prohibit the marketing of drugs in the United States. In France, the National Agency of Drug Safety (Agence National de Sécurité du Médicament or ANSM) holds that role. 

 

The Animal Rule facing the Ebola crisis

 

The American FDA, in its effort to control the Ebola outbreak, has accelerated the availability and the development of drugs, vaccines, diagnostic tests and personal protective equipment.


The Animal Rule is part of this initiative. It allows the demonstration of the efficacy of treatments with the support of experimental data obtained in animals when human trials are not feasible.

 

Because of the severity of the symptoms and the high mortality rat, trials in humans would be too dangerous and unacceptable from an ethical point of view. Therefore, the availability of the ‘Animal Rule’ allowed for the “licensing of vaccines or antivirals based on evidence in well-characterized animal models”, according to a scientific publication in the Genome Medicine Journal. 

 

For more information: News and Information from the FDA about the Ebola outbreak