vol1 - Page 322
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demonstrate marijuana can be chemically and pharmacologically
defined and #standardized _ to FDA°s satisfaction°
While DEA claims marijuana cannot be "standardized_ _
Government witnesses from NIDA and FDA have consistently
characterized NIDA_s federally produced marijuana (DEA#7360) as
mstandar_iz_d and mauthentic_#_-_/ This view is shared by
Carlto_lurner who initiated the University of Mississippi's NID_
contracted marijuana cultivation program. 3_6/
Clearly_ federal agencies, including DEA, FDA and NIDA
have defined marijuana and are able to produce a form of
37/
marijuana which all three agencies recognize to be marijuana.
It is equaliy clear marijuana's chemistry_ pharmacology, animal
toxicology studies_ and other0 pre-Phase I evaluations are
described to FDA satisfaction in NIDAts Marijuana Drug Master
Fileso _-_/ Based on this information, FDA has approved more than
___/ Affidavit of Richard Hawks, _ 3 _In order to facilitate
[marijuana] research it was necessary [for NIDA] to provide
authentic and standardized supplies .... n __do; Affidavit of
Robert Temples _ 4. According to Dr. Temple, to obtain IND
approval to conduct human studies, _The drug must [first] be
characterized chemically .... _ _9__ !lg_q Hawks Exhibits 2 & 3
ACT Brief at 25o26.
2u_/ ACT Brief at 25=26_ See als_q Rebuttal Affidavit of Robert
Randall, Exhibit I at 15_
3// All three agencies must approve marijuana research. FDA
must review and approve the IND protocols_ DEA must approve
security arrangements and NIDA must actually supply the marijuanas<
38/ Affidavit of Dr. Robert Te2_ple_ _ 5. According to
Dr. Temple, WThe initial concern of FDA . . . is the safety of
the proposed studies° A determination that a study is safe
enough to proceed is based on _ . . animal tests carried out to
evaluate toxicity .... _ /_. at _ 4.
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