Page 257

the safety and effectiveness of drugs on the basis of which it could fairly and responsibly be concluded by such experts that the substance will have its intended effect in treating a specific, recognized disorder.

4. The drug must be accepted by qualified experts.

The drug must have a New Drug Application (NDA) approved by the Food and Drug Administration . . . or, a consensus of the national community of experts, qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, accepts the safety and effectiveness of the substance for use in treating a specific, recognized disorder. A material conflict of opinion among experts precludes a finding of consensus.

5. The scientific evidence must be widely available.

In the absence of NDA approval, information concerning the chemistry, pharmacology, toxicology, and effectiveness of the substance must be reported, published, or otherwise widely available in sufficient detail to permit experts, qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, to fairly and responsibly conclude the substance is safe and effective for use in treating a specific, recognized disorder.

SOURCES: LeCraw (1996) and 57 Federal Register 10499 (1992).



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement