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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