vol1 - Page 82

 efficacy. _/ If this is indeed the standard chosen by DEA_ it is
 certainly invalid_ A _asi_NDA approval _ is equivalent to an
 ,.,i.i_ actual NDA approval because FDA_ as an impartial arbiter and drug
 reviewing agencye necessarily would approve a drug that has
 satisfied all cf the requirements for an NDA. Thus_ if this
 ......._
 reading of DFEA's wnew standard _ for defining _accepted medical
 use in treatment in the United States _ is correct, it is not
 binding upon this tribunal and the ALJ is free to vary from its
 strictures° 2_/
 Since DEA_s recent ruling in the MDMAproceeding is
 susceptible to a variety of interpretations, the standard may
 indeed coincide with the obvious and only reasonable meaning of
 the phrase Naccepted medical use in treatment in the United
 States # intended by Congress _ that the medical community
 _- consisting of patients and doctors -- as regulated by the
 statesF accepts a particular drug as having medical utility.
 _/ It is difficult to understand why the DEA takes the
 position that NDA approval, or its equiw_lent, have anything to
 do with defining #accepted medical use in treatment in the
 United States. _ Prior tc the commercial marketing of a drug_ the
 Federal Food, Drug and Cosmetic Act requires that a
 pharmaceutical company must satisfy certain standards of efficacy
 and safety. ___ 21 UoS.C. § 355 (1982)_ Plainly, as the
 _/_iD93_oo_ court indicates_ a drug may have an #accepted medical
 use in treatment N whether or not it satisfies the NDA standard.
 828 F_2d at 887° The FDCA_ however, newer uses the phrase
 Hmedical use. w In fact, the FDA has no authority to intrude upoD
 ......
 the practice of medicine. FDA_ itself, has made this clear on
 many occasions. Se_0 __q_t 37 Fed_ Reg. 16,503 (1972)
 (physicians may prescribe beyond indication; FDA lacks authcrity
 to requlate practice of medicine); 40 Fed® Reg_ 15,393-94 (1975)
 (same); 44 Fed. Req® 435=36 (1979) (requlations cf FDA do not
 apply to the practice of medicine); 48 Fed. Reg. 2673 (1983).
 Thus, FDA standards have nothing to do with the determination of
 whether a drug is cr isn't accepted in medical practice°
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