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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 i_ is unsafe. United
 States v. Rutherford_ 442 UoSo 544 (1970).
 The scheduling criteria of the Controlled Substances
 Act appear to treat _he 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 22t 1988). In ret_ospect, this is
 inconsistent with scientific reality_ Safety cannot be
 treated as a separate analytical question°
 C. There Must Be Adequate and Well-Controlled Studies
 Provinq_ Efficacx.
 Since 1962_ Congress has prohibited the FDA to approve
 an NDA unless the applicant submits adequate, well-
 contro!led_ 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.SoC. 355(d); 21 CFR 314o!26o Similarly_ a drug cannot be
 considered GRASE unless it is supported by this same
 quantity and quality of scientific proof. 21 CFR
 3!4.200(e) (i); Weinber_g_er v_ Hyy_nsp_D_L_Etc. g 412 UoS. 609, 629
 (1973) .
 Studies involving related_ but not identicalt drugs are
 irrelevant. United States v. Articles of Food & Drugs 518
 F.2d 743_ 747 (5th Ciro 1975). Studies involving the same

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