norml09 - 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 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
(1973).
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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