vol1 - Page 361

 quite literally, the only generally accepted standard for making
 such an assessments 152/
 By the government's own admission, _reduction of
 intraocular pressure _ is the ntraditionalH5_/ standard for
 determining efficacy. It is the standaD_ FDA employs to review
 ..... glaucoma treatments_ 15_/ It is the only specific therapeutic
 indication given to glaucoma drugs listed in the physicians Desk
 Referenceo 15-_/ Xt is the standard that the ophthalmic community
 has accepted for nearly a century as the only reliable means to
 152/ ACT Brief at 130-132 & 166-170o _ee _i__qs Rebuttal
 Affidavit of Dr. John Merritt_ _ 51-59_ Dr. Meritt testified:
 There simply is no other acceplzed standard
 against which to judge the reflectiveness _ of
 a _laucoma control therapy. All drugs now
 accepted as reflective x in the treatment of
 glaucoma were deemed to be effective because
 they significantly reduce intraocular
 pressure. There is no other basis upon which
 this determination of effectiveness was
 reached° None. _o at _ 55°
 i_/ Affidavit of Dr. George Spaeth at 7. ACT Brief at 169.
 DEA Brief at _ 68_ at 41_
 _54/ Cross-examination of Dr. Richard North_ Tr. 7-91. Dr.
 North, a former ophthalmic drugs IND/NDA review officer for FDAf
 was asked what is required to establish _at a drug has an
 accepted medical use in the treatment of glaucoma. Dr. North
 replied:
 That [the drug] does reduce . _ o intraocular
 pressure . . . [D]rugs have Jpeclflc
 indications for specific diseases ....
 [W]e're talking about reduction of intra-
 ocular pressure [as the specific indication]°
 Does a drug indeed reduce intraocular
 pressure? /__o at 7-91 & 7-S2°
 /__/ ACT Rebuttal Exhibit Tab B. _Reduction of intraocular
 pressure u is the only medical indication given to glaucoma
 therapies in the Phvsic_aDs Desk Re,CreDOS.