[Letter to William N. Natcher from David Kessler]

HF'F. 15' 93

14. 4 2 Ho -.iG", I'D,
4Ji4o86 va~

4A

4 a- J;hs onrableWilim K atcher
P'anol 1a xmomttt~ls Meetirnqof 3aiiuary i 9091't0 be a
rreable aproach tax, this a,tiLaitxa2l. Zowever, the Plan
to oondizgt this trialZ buhil4 be poannidere4 in thie oontxt 'of the
utatiuttQr regulator1 ruviek and4 Lioeiast~ws prvOGbReSS DA vill
revew todt~nfar tio anid the rqlults *tof niklA. a d
human ut&1ei o ia aM.'hmYoaar sebais to dteninQit eioh
pvOWQ5B4 poduct is u I table tor use in am efficacsy, trial for the
tan44dtie~r~bpvplabLon. Yo faoi~itate thb proo.uns1 the PDA
v 1 aatllu to rssethe DabDed 4tihe UwZi(th the t'whi
daeopi.tt of tJhe aiioal protboool and related ipisu.#i, and
provLG. otshrz support i~s rsQuJtih, such as ass istanos vith
candidate vaooine semioiin. T himtatrial2. iirn*heuI6be
revtowead drybpFDA ad Mth4 trial iki tbe oqnducao~4d inaaoasWdang.
with IDA:'sulstioais.,

It ahovl4d4I1s~m 4that @Owutin! on at~iaady
not guzsn t~s Ionvure. F7M vi;LIrev ow th. tria
sack produiot eMI in mnutatIorxwivth FDA advisor
bez~ aty[othr w p tst, Qty,,n.whtber or no
u'.pprt Ucnsuria for uipaaif5e pmtient population.

results for
the dots

we ho that this appweprition wiill advance th* devolopmwnt of.ffea~4vs AIDS bexapoetiou.
Sincrelsy youre
ate: f1e onorables' 70eph P. Xoade4
Pknk, nq ineriW
COILULttse an &propzrLatioai
Ifouia lof aepesenlttivos

The Ito~orabls nobeit Byrd
Cha Lwaan
ccammLtt.. on Appropriations
thltk4I4 Stas 3~ia
The WQOZarb;IO Hark 0. Katfield
RuangXr Knorw.ty
CORNLt* 4S on Appxoprtionu
Utn~ts4 States BeaIate
Das=io~ebed iri the V. uouy 24f
NUH'gpL6O Panel 5ubaoittse *seitinq

r
I

19 9 Sumna )F Report of -the
of Janruary 28, 1993.