norml11 - Page 32
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ruled, instead, that DEAlsdecision on _hether or not a drug or other substance
had an accepted medical use i_ treatment in the United States _ould be deter-
mined s_mp|y by ascertaining whether or not "the drug or other substance is
lawfui_y marketed in the United SLates pursuant [o the Federal .Food, Drug and
.Cosmetic Act of 1938 . . ,9
The United States Court of Appeals -for the First Circuit held that the
Administrator erred in so ru_ingo I0 That court vacated the final order of
October 8, 1986 and remanded the matter of MDNA's scheduling for further con-
siderat_on. The court directed that, on remand, the Administrator would not be
permitted to treat the absence of interstate marketing approval by FDA as con-
clusive evidence on the question of accepted medical use under 1_he Act.
In his third final rule 11 on the matter of the scheduling of MDMA the
Administrator made a series of findings of fact as to MDMA, the drug there under
consideration, with respect to the evidence in that record. On those findings
he based his last final rule in the cases 12
9 Ibid., at 36558.
Grins oo_ v. DoT Enforcemeat Administration, 828 Fo2d 881 (Ist. Cir.,
11 53 Fed. Reg. 5156 (]988). A second final rule had been issued on January
20, 1988. It mere_ly removed MDM.A from Schedule I pursuant to the mandate of
the Court of Appeals whiich had voided the first final rule placing it there°
Subsequently the third final rule was issued, _ithout any further heariags,
again placing MOMA in Schedule I. There was mo further appeal.
12 la neither the first nor the third final rule in the NDNA case does the
Adm_mistrator take any cognizance of the statements to the Congressional
committee by predecessor Agency officials that the determination as- to
"accepted medical use #n treatment" is to be made by the medical community
and not by any part of the federal government. See page 27, above. It is
curious that the Administrator makes no effort i_hatever to show bow the 8ND0
representatives were mistaken or to explain _hy he now has abandoned their
interpretation. They wrote that language into the original bill.
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