norml08 - Page 29
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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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