norml11 - Page 35
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In the MDMA third final order DEA is actual_y making the decision that
doctors have to make, rather than trying to ascertain the decision which doctors
have made. Consciously or not, the Agency is undertaking tG tell doctors what-
they should:or should not accept. In so doing the Agency is acting beyond the°
authorit]} granted in the Act.
It is entirely proper for the Administrator to consider the pharmacology of
a drug and scientific test results in connection with determining abuse potential.
But abuse potential is not in issue in this marijuana proceeding.
There is another reason why 0EA should not be guide._ by FDA criteria in
ascertaining whether or not marijuana has an accepted medical use in treatment.
These criteria are applied by FDA pursuant to Section 505 of the Federal Food,
Drug and Cosmetic Act (FDCA), as amended. 13 When the FDA is making an inquiry
pursuant to that legislation it _s _ooking at a synthetically formed new druq.
The marijuana plant is anything but a. new drug. Uncontroverted evidence in this
record indicates that marijuana was being used therapeutically by mankind 2000
years before the Birth of Christo L4
Uncontroverted evidence further establishes that in this country today _new
drugs" are developed by pharmaceutical companies possessir_g resources sufficient
to bear the enormous expense of testing a new drug, obtaining FDA approval of
its efficacy and safety, and marketing it successfullyo No company undertakes
the investment required unTess it has a patent on the drug, so it can recoup its
development costs and make a profito At oral argument Government counsel con_
ceded that "the FDA system is constc_cted for pharmaceutical companies. I won't
13 21 U.S.Co § 355.
14 Alice M. O'keary, direct, par. 9.
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