vol1 - Page 322

Page 322 Previous , Next , Original Image
Return to Index

 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
 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.

Previous , Next , Return to Index