norml09 - Page 33
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During the NDA process, the FDA may reach out to the
expert community for its views° 21 CFR 314oi03(c) (3)_ The
FDA need not determine that a drug is generally known and
accepted by the expert community. Nor must the FDA develop
a censensus of opinion among outside experts. The FDA has
both the experts and the statutory mandate to resolve
conflicts over the safety and efficacy of new drugs.
Weinberq__ v. Bent_______aceuticals Inc._ 412 U.S. 638,
653 (1973) o
In drafting the Controlled Substances Act, Congress
appears to have accommodated_ rather than chosen from these
different FDCA standards. Clearly_ the Controlled
Substances Act does not authorize the Attorney General, nor
by delegation the DEA Administrators to make the ultimate
medical and policy decision as to %_ether a drug should be
used as medicine. Instead, he is ]_imited to determining
whether others accept a drug for medical use° Any other
constzn/ction would have the effect of reading the word
_accepted _' out of the statutory standard. Since Congress
recognized NDA_approved drugs as having currently accepted
medical uses_ without any need for a national consensus of
experts_ FDA acceptance of a drug through the NDA process
would seem to satisfy the Controlled Substances Act° And_
since Congress recognized GRASE drugs as having currently
accepted medical uses, without the need for NDA approvals
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