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 effectiveness are inextricably linked in a risks-benefits
 calculation. A determination that a drug is ineffective is
 tantamount to a determination that it is unsafe. United
 States v_ Rutherford; 442 U_S_ 544 (1970).
 The scheduling criteria of the Controlled Substances
 Act appear to treat the lack of medical use and lack of
 safety as separate considerations° Prior rulings of this
 Agency purported to treat safety as a distinct factor° 53
 FR 5156 (February 22_ 1988). In retrospect, this is
 inconsistent with scientific reality. Safety cannot be
 treated as a separate analytical question.
 C. __gre Must Be Ade ate and Well-Controlled Studies
 [rovinq _fficacyo
 Since 1962, Congress has prohibited the FDA to approve
 an NDA unless the applicant submits adequate_ well-
 controiledf well-designed_ well-conducted_ and well-
 documented studies_ performed by qualified investigators,
 which prove the efficacy of a drug for its intended use. 21
 U.S_Co 355(d); 21 CFR 314_126. Similarly_ a drug cannot be
 considered GRASE unless it is supported by this same
 quantity and quality of scientific proof° 21 CFR
 314.200(e} (i): W einber er Vo H nSOnLEtC_B 412 U.S. 609, 629
 Studies involving related, but not identical, drugs are
 irrelevant° United States Vo Articles of Food & Druq, 518
 F.2d 743, 747 (5th Ciro 1975) o Studies involving the same

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