[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 Il l II~ 0 l111115705 111111111111

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.