norml08 - Page 33

 ....
 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 consensus of opinion among outside experts. The FDA has
 both the experts and the statutory _andate to resolve
 conflicts over the safety and efficacy of new drugs.
 Weinberqer v. Bentex Pharmaceutical_b Incus 412 U_S_ 638_
 653 (1973).
 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 Administrator_ to make the ultimate
 medical and policy decision as to whether a drug should be
 used as medicine° Instead_ he is limited to determining
 whether others accept a drug for medical use° Any other
 construction 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. Ands
 since Congress recognized GRASE drugs as having currently
 accepted medical uses_ without the need for NDA approvai_
 33