FDA AMENDS ITS REGULATIONS TO PROVIDE FOR APPROVAL OF CERTAIN NEW PHARMACEUTICAL PRODUCTS BASED ON ANIMAL EFFICACY DATA

The Food and Drug Administration has amended its new drug and biological product regulations so that certain human drugs and biologics that are intended to reduce or prevent serious or life-threatening conditions may be approved for marketing based on evidence of effectiveness from appropriate animal studies when human efficacy studies are not ethical or feasible. The agency is taking this action because it recognizes the need for adequate medical responses to protect or treat individuals exposed to lethal or permanently disabling toxic substances or organisms.

This new rule, part of FDA's effort to help improve the nation's ability to respond to emergencies, including terrorist events, will apply when adequate and well-controlled clinical studies in humans cannot be ethically conducted because the studies would involve administering a potentially lethal or permanently disabling toxic substance or organism to healthy human volunteers.

"The terrorist attacks of last fall underscored the acute need for this new regulation," said FDA Deputy Commissioner Dr. Lester M. Crawford. "Today's action will help make certain essential new pharmaceutical products available much sooner - those products that because of the very nature of what they are designed to treat cannot be safely or ethically tested for effectiveness in humans."

Under this new rule, certain new drug and biological products used to reduce or prevent the toxicity of chemical, biological, radiological, or nuclear substances may be approved for use in humans based on evidence of effectiveness derived only from appropriate animal studies and any additional supporting data. Products evaluated for effectiveness under this rule will be evaluated for safety under preexisting requirements for establishing the safety of new drug and biological products.

FDA proposed this new regulation October 5, 1999. The final rule went on display today and will be published in the Federal Register Friday, May 31.

The rule will take effect June 30, 2002.

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