vol1 - Page 207

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 physloians_ that Ea drug] would have the
 eEfects of lowering pressure and it would be
 u_ed by ophthalmologists for those reasons.
 Before 1962_ there was a whole class of drugs
 _DA had to deal with .... Because of
 their long-term use, they were sort of
 grandfathered wlth indications for lowering
 pressure. Even thouah_h__reyer_nq__cific
 _ub_e-blind studies to p_ove__Ethev_lowered
 _ular tensions_ (Emphasis added) 9-_I
 According to Dr. North_ _Timolol is the only [lOP
 lowering] drug that I'm aware of that had double blind
 i. li studies. W_-4_/ This conclusion was confirmed in an exchange
 between the government and Dr. John C. Merritt:
 Ms. Shirley: Ands correct me if r am wrong_
 but the only glaucoma agents that have come
 to the market after the passage of the Food,
 D_g and Cosmetic Act [amend_ent of 1962]
 have been beta blockers, including Timolol
 and the more recent beta blockers, correct?
 Me_itt: That's correct. !_I/
 Thus_ it is undisputed that thre_ of the major families
 of glaucoma control drugs _- the miotics_ epinephrine compounds,
 and the diuretics -- achieved wide=spread acceptance within the
 ophthalmic community prior to the IND/NDA procedures and have
 never been subjected to rigorous efficacy analysis. More
 significantly, these drugs_ which are c1_rrently accepted for use
 in the treatment of glaucomas were not initially indicated for
 use as lOP-lowering drugs. Only by phy_sicians prescribing these
 drugs beyond FDA indication did they gain recognition and
 _u_/ i do at 7-99 & 7_I00.
 __4_q/ /_. at 7-99.
 __i/ Cross_examination of Dr. John Merrittr Tr. I0-125.
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