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case. [footnote 12] 
____________________ 
9    Ibid., at 36558. 
10   Grinspoon v. Drug Enforcement Administration, 828 F.2d 881 (1st. 
     Cir., 1987). 
11   53 Fed. Reg. 5156 (1988).  A second final rule had been issued on 
     January 20, 1988.  It merely removed MDMA from Schedule I pursuant 
     to the mandate of the Court of Appeals which had voided the first 
     final rule placing it there.  Subsequently the third final rule was 
     issued, without any further hearings, again placing MDMA in Schedule 
     I.  There was no further appeal. 
12   In neither the first nor the third final rule in the MDMA case does 
     the Administrator take any cognizance of the statements to the 
     Congressional committee by predecessor Agency officials that the 
     determination as to "accepted medical use in treatment" is to be 
     made by the medical community and not by any part of the federal 
     government.  See page 27, above.  It is curious that the 
     administrator makes no effort whatever to show how the BNDD 
     representatives were mistaken or to explain why he now has abandoned 
     their interpretation.  They wrote that language into the original 
     bill. 
                                  - 30 - 
That third final rule dealing with MDMA is dealing with a synthetic,  
"simple", "single-action" drug.  What might be appropriate criteria for a  
"simple" drug like MDMA may not be appropriate for a "complex" substance  
with a number of active components.  The criteria applied to MDMA, a  
synthetic drug, are not appropriate for application to marijuana, which  
is a natural plant substance. 
     The First Circuit Court of Appeals in the MDMA case told the  
Administrator that he should not treat the absence of FDA interstate  
marketing approval as conclusive evidence of lack of currently accepted  
medical use.  The court did not forbid the Administrator from considering  
the absence of FDA approval as a factor when determining the existence of  
accepted medical use.  Yet on remand, in his third final order, the  
Administrator adopted by reference 18 of the numbered findings he had  
made in the first final order.  Each of these findings had to do with  
requirements imposed by FDA for approval of a new drug application (NDA)  
or of an investigational new drug exemption (IND).  These requirements  
deal with data resulting from controlled studies and scientifically  
conducted investigations and test. 
     Among those findings incorporated into the third final MDMA order  
from the first, and relied on by the Administrator, was the determination  
and recommendation of the FDA that the drug there in question was not  
"accepted".  In relying on the FDA's action the Administrator apparently  
overlooked the fact that the FDA clearly stated that it was interpreting  
"accepted medical use" in the Act as being equivalent to receiving FDA  
approval for lawful marketing under the FDCA.  Thus the Administrator  
accepted as a basis for his MDMA third final rule the FDA recommendation  
which was based upon a statutory interpretation which the Court 
                                  - 31 - 
of Appeals had condemned. 
     The Administrator in that third final rule made a series of further  
findings.  Again, the central concern in these findings was the content  
of test results and the sufficiency or adequacy of studies and scientific  
reports.  A careful reading of the criteria considered in the MDMA third  
final order reveals that the Administrator was really considering the  
question: Should the drug be accepted for medical use?; rather than the  
question: Has the drug been accepted for medical use?  By considering  
little else but scientific test results and reports the Administrator  
was making a determination as to whether or not, in his opinion, MDMA  
ought to be accepted for medical use in treatment. 
     The Agency's arguments in the present case are to the same effect.   
In a word, they address the wrong question.  It is not for this Agency to  
tell doctors whether they should or should not accept a drug or substance  
for medical use.  The statute directs the Administrator merely to  
ascertain whether, in fact, doctors have done so. 
     The MDMA third final order mistakenly looks to FDA criteria for  
guidance in choosing criteria for DEA to apply.  Under the Food, Drug and  
Cosmetic Act the FDA is deciding - properly, under that statute - whether  
a new drug should be introduced into interstate commerce.  Thus it is  
appropriate for the FDA to rely heavily on test results and scientific  
inquiry to ascertain whether a drug is effective and whether it is safe.   
The FDA must look at a drug and pass judgment on its intrinsic  
qualities.  The DEA, on the other hand, is charged by 21 U.S.C. Sec.  
812(b)(1)(B) and (2)(B) with ascertaining what it is that other people  
have done with respect to a drug or substance: "Have they accepted it?;"  
not "Should they accept it?" 
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