norml08 - Page 34
Page 34
Previous ,
Next ,
Original Image
Return to Index
acceptance of a drug by a national consensus of experts also
would seem to satisfy the Act.
When a drug lacks NDA approval and is not accepted by a
consensus of experts outside FDA_ it; cannot be found by the
Attorney General or his delegate to have a currently
accepted medical use. To do so would require the Attorney
General to resolve complex scientific and medical disputes
among experts, to decide the ultimate medical policy
question, rather than merely determine whether the drug is
accepted by others_
Because the recognition of a drug by non-experts is
irrelevant to GRASE status, to NDA approval, and to
currently accepted medical use under the Controlled
?_
Substances Actr points seven and eight of our eight-point
test should be combined and restated as follows:
The drug has a New Drug Application (NDA) approved
by the Food and Drug Administra-sion pursuant to
the Food, Drug and Cosmetic Act, 21 U.S.C. 355.
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 disorders. A material
conflict of opinion among experts precludes a
finding of consensus.
This restatement also incorporates the component of
part one of our eight_point test concerning _accepted
knowledge of its chemistryo _
E. _e Scientific Evidence Must Be Widel Available.
Nothing in the FDCA nor in FDA's regulations requires
34
Previous ,
Next ,
Return to Index