norml02 - Page 12
Page 12
Previous ,
Next ,
Original Image
Return to Index
3o The Administrator's Interpretation of the Statutory
Standard
While the administrative proceedings in this case were
pending, the Administrator issued a final rule placing another
drug_ 3,4-methylenedicxymethamphetamine (MDMA), into Schedule I°
I 51 Fed. Reg. 36,552 (Drug Enforcement Administration, DepOt Just.
1986). This ruling rested partially on the Administrator's
conclusion that any drug having a "currently accepted medical use
in treatment in the United States" must have FDA approval for
I marketing in the United States pursuant to the Federal Food, Drug
and Cosmetic Act of 1938 (FDCA) _ 21 U.S_C_ 355 (1988) _ The
Administrator noted that FDCA procedures require the FDA to
"approve a new drug as being safe may
and
effective
before
it
be
introduced into interstate commerce." 5] Fed. Reg. at 36,558.
J On review of that order, the First Circuit remanded the case
I to the Administrator. Grinspoon vo Druq Enforcement
Administration, 828 F02d 881 (ist Ciro 1987) [hereinafter
Grinspoon]. The court noted that, because of numerous
requirements under the FDCA that are unrelated to safety and
I efficacy, a safe and effective drug may not necessarily be
approved for interstate marketing. I do at 887° The court also
observed that, in the absence of "economic or other incentive to
I seek interstate marketing approval" for a particular drug, the
FDA may never review it for safety and efficacy. Id. Therefore,
i the court forbade the DEA's "blind reliance on the lack of an FDA
interstate marketing approval" as the basis for placing a drug
into Schedule I. id. at 888_
M
Previous ,
Next ,
Return to Index