[Letter to William N. Natcher from David Kessler]

FPR 5 '93 06:52 S&-TtMft aG: iD) C (703) V'-6
1DEPARTM~rNTOIl;LCiP;MNFRIE ib4 5AtIh tte ''
Pond wMd Oiig dr~kIJr.iio;
April. 1,R* 1993 ~ ~ CM
Wb. lonorabis VLi4L. che
~Co ~ttEc oOh AppropriatiLons
oe04o6 QC apr.eutivre
1iuhin'town0 D.C. 3O53.5
hear XIto Chairma~n:
The 2993 Departbuiutot efe Ap rpriations Act provided *20
milionfo a large ac'ale Phase 11oltiid& investigation o.
the GP-UO 0vaccineB, v.0 r *o'*,the, appropriation i anguaBr
*peoieidl that the fuands be ob Igated ui~q within eLK months
after the 4data of the a W* otof this Mat 'the Seoratary'of
Der ae t)etisotor o u atoa ntiktsoUchan
the Coi *SSaner of Food, aid Drg iq.baL. 'to the Com tteon
AproprLti@na Othe 5Mt and -the Ho a*d*g epreasntat$.v.. a
wr ten tartit Son lotaLirtfljTa dott ntion of mc
offikal tha th tars oalo ax% l 4inical i nvestigation
soud not prooaed, the reasons "fo that determination, and an'
asseussment of ale GP~lSO V&oi.H
To ad eatis appro L'atinfr liet. htioncl X*titutes of Health
E(IB) a wnend a pane of eMpertw to provide advice and
reoouendatioris aonoerng the roZ056d therapaltio ~Vvaoo ins
of f cao trial1,. h paneL ropycsed a dqsigii for an off ioao
tria t oull evluae aclinical benof it of the canididate
vaooinea to' trial participants. The Food and Druqg 4inimtrationt
(FDA) pa tiaipatsd in all of thbsu. panel meetings and cont~ributed
to the vcik1W prodhaiots of these u "tin sincluding the issue paper-.
from the VW"aAO Trial Desiiqn Tes n addition, the Department
of Defense (DOD) hl IN aosateD DeGPwl6O Panel tooting with
its +w1 group of expsr s t,t. attendod as. nonvoting
ybserVr Jand.ro merutaor. Ai-& t '_ -&ADD _eeing,..Lssu__--EuqLI-as

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