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 effect of a drug from other influences, such as spontaneous
 change in the course of the disease, placebo effect, or biased
 observationo _' I_d. The regulations preclude findings of
 effectiveness based only on "uncontrolled or partially
 controlled studies." I=do at 314_!26(e) o Furthermore, "isolated
 case reports_ random experience, and reports lacking the details
 which permit scientific evaluation" have no evidentiary value.
 Ij.
 Once the 1962 amendments became effective, the FDA reviewed
 all drugs that had previously been marketed pursuant to approved
 NDAs to determine their _therapeutic efficacyo '_ Weinberger v.
 Hvnson_ 412 U.S. 609, 614-15 (1973) (citing 37 Fed. Reg. 23,185;
 21 C.F.Ro 130.40). 6 In addition, the 1962 amendments excluded
 from the definition of "new drug *' and, therefore, from the New
 Drug Application process, any drug:
 generally recognized, among exper'ts qualified by
 scientific training and experience to evaluate the safety
 and effectiveness of drugs, as safe and effective for use
 under the conditions prescribed, recommended, or
 suggested in [its] labeling°
 21 U.S.C. 321(p) (1) (1988). The NDA process also applies to "new
 animal drugs" that are separately defined at 21 U.S.C. 321(w)
 (!988) o This section contains a parallel exclusion for drugs
 that are _'generally recognized as safe and effective." 21
 U.SoC. 321(w) (i) (i988). Drugs that are "generally recognized as
 6 The results of this review also applied to drugs that,
 although not themselves marketed pursuant to an NDA, were
 identical or sufficiently similar to other drugs to have been
 marketed in reiiance on the _-_DAs that applied to those other
 drugs.
 !5