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,~.esthanutt>rbl~lrof deCisions deCf'e;Rsed Prodtut chan98 deoisi0ns:, 9.0.9 1 i y Yom Haa~tatirBer ;igahjngtcn 8uraau Chiet v.srtintot+, a,C. M iaagaota medics3 tacssootop c,ompaaies aite a isatt of rea• sasU4ot thtar der.i:ions to emind ovetuu, but b<sh an titE iist is tke need to aatpe te;ttlstoty atsrd.les set up the US. Foad aad DruS Admuustration (DA). '"rba sttituda of the FDA ts so trtibus'saeas apd:oaup tivo,t this point thit anypru dertt CFA has to be looi;ht; out;ide ths U.S. as a sats btvon." raid LoVU ead-ntiaa. ehd Approvat review time inareased . • . Gotp, ot Misrt"poiis, who le.{d off 50 Mittucioia imp?o as wbils e~tyyutd• ww e. Aveuaqo tuwbar of days tyeded to CoS PCA ppprpvil or a peoduet ' o e: , :;4ost Minne30ta tnsnu- I facmren asen't autung ststt. Rut Coaentina's sent titnent re6eets sfut ef ttsaay of tbe high•teeb CEGe in btinrtesota sur- vaysd by the Star h'sburu. Tbelr vaeas rtzays4upd like ttte sSe•old cam• ptaint: ot aa ioduaty tssaptsd w put proflts !8 $2 98 '88 's9' °9Q ihesd of Wsoty. But the r:oturoversy regects new derrols of diuwtteat ttnd real probleots at the oMerburdsa.d agetv.y t>Set persittt svsa as Aew le;dees pusts for lasprovemeats. ~ At j;istte in the tauraaM fttieh is, 5tst, a ler in tppovai ticses for ttsstketiab new tec~oi• o®r in the Ueittti Statu, whjeh keepa darira .yailsbte itt Sumi or Asia from the 1990, l~A~b.aftioss bi1+0 gzocn+, i~a~ i~ dowen daviee iraproveaaeat apptustioas Vweiciaj•doaiaioro towatl ava a aboutettd. Seoond, butLteaas ttt+d many prssts'tlotYers objaa to the agency's rereat tmplementatton oEneW, tougher re,wz+. tieat. S hey preier the iets aoaarroetaaots:t tystams pwalut in Eur"& ad Jtp1a ind point, wit3t aoatpetttive coacasa, to na3w aaitom deviss tegu• latio0n fot >`U ot Easope t>hst So iato eifea e that attd ef tJli. yW. ~OC 1.>s '91 '9Z t?ver5taa pRtieats aleuly ,tfwe aicliar•susaa to !* tecbnetogy do++ioas than Americscu. Debate lr atadiesl eindas oenttra an whttber that is an adm• taEe or a dsrtdmtage. Aroeriaaa hoan atr eons iatetviewed by tluut: Ttibuu rtitieised tlte FDA for slowinS pregrest in tbeir fuld. ~ ~ ® U 'a9 '90 'A1! '92 6aufcx FDACtiko oi Llavtas BvaGAtidA An FDA-medioa2 oWcar, Dr. ti11oII $lpirstei4 a dtoseaiesuraooa uid a nudieal oifiar, rsid be believe; tJ,C eare tmsiac tupenar. His ricw ~rss btcked by Dr. SidrsryVolfa, who monhols heshb is:ues for BsJph Nsder't Public Citizen orge• ahetion. Woite sstyx indtstry is ccmplaitting..c it , always has oad.tbat tha"taua psaoieat w9th device t.gvn atioa 's th:t ehere iu ttot enou q of iS." YJNfe said Asaosiean patie:,ts ertd the iAdustry ete ptpteeted bysouper standards. '1'hese is little debate, bowevet, over the aeed to itlfpreve cemmunisatioasm tttorale attd efltefeaey-,panculsrlr la reducing ber.ldogl--zt the FDA.1r bu become a pri. atiry ot the• director Q( the Ce>ster for Dav;ccs aad Ratiioiojiesl Hea]th. Dr, Bruce BUliaacotr, the fitu 1H.D. to ltdd the post. Sitfee his sppointment in 1992, Hudinaton htt scjmowkdged preblams in weitin6 titaas and can sbow soms iruprovameat. }ie atso hst eaked iddttstry to eoetribtru by itt#pYOvWg the quality of data it sutmit, asy- tflg tnany applkations are tubstnds'sd. HIs eEiorts are~eaaraqy appiauded by indU ®xewtives, Dt3t tbey say ttte wait~ pet eetnein unaaepably lona. "Iatokra~e." ?h.t ti.ae the catu]usion last iu~of a eongressionei sttii review of -ths adt+noy-'s growing delays b proeesdag spplieations lor n.W and modified devices. Last week. Medtiotue q)okestwan piak Raid estimated the proees: of aamins retulatory apptovtd takes sfl averago of rwo to three years in the tJditbd States veraus six te eight moathi in Eurepc and "tlse = in the Uait- ed States is e0 to 50 petcatu hi=het and tis-- ini TapidlY " The lieS tit3te aut~as ms111oas to a aompany 'witb aneatpr.nsive devictwtitidi to to to tsstsrket and tt providm reai sdviatsrs to thoaa opesaua overxis. Cancer# etntex on M cakpries of approvfiJ by the agent.yy. '[tte first is tor de+rfioec hat differ anty siigbtly from pxod• ucts s~1,t~gdy on the marhet. It 160 FDAagoas with the nsanuiacturets' cantention that the momcuioa is aliSbt, tl deviao I in quie>rsy enter the market. I•D,1;uidoiine# roquirc that these so.callai S!Q-x appiiaidons be spproved.+ithin 90 days. Uatil mid•1M that wtwn't a ptoblez .4t tbe e6Innia~ oi t6st year, anty 12 appl Gs ' totik longer than-the i.llotted tlztce tttorttb ~ La,tt Jaauary, howtiwer, I,S2S ¢ppl N4~ad been peadiltS for mcre tban tt perindi By MaretS the batklog had droppei to S,l~~1. Tbc second rategory o approval is Cot aaw deriees, Qose unlike s tbi~ now u:ed in mecd c•'ss. in 1990.47 devia received FItr4 sppravr wittitu the reqvssue 18 dsy ippravsi tEme. In 1992, only 12 ptnduett were authorised a1t ye while htusdmdi of otb Were reqttited eoc•~ taora io~+ation, wl: e:teitdu! we11 aet tb liG-dayJtriod. In 19 YjlPr'oVtJ doub34d to : pp I-ast wrsrrtx:, auriie utaonnead a new pri gr sm to speed ap oval with a tovr•pro, Jp aoh that iudes~ expediting appr lif Wviag devtaes; reduCiag scmtioy t ,lowe4-risSc deti~ex, intptot~Eag eaeanttuu t108 ~'itb manufacturat7 anry speedy tej, tioa oi incamplete applicxtions• Burtittitor's stafi;atutioai tbat gpeetiuf mry §e difficuh beesuu de++iees are ae .raarM eornptiated and demaads troat t grese and tme puwC oNy increase, oftr without appropriate uuteasei in staff.

• tl`ht a{iY iiweZttlgatiQttf 3vbCOMr83LLGG fourtd, "'i7+e orgaaisstianet probkmi within tlte ~agcuryj ate severc and avt: rcacbcd s critl- eaI paibt wture unwtr ranted drlqt; aad indeei- 3iost are liatitiab bene5lt to the publtt: heaitb.. . :' 5c~pe~d•uP ettforeemettt wt the FDA is dasigaed. . to avoid tututa pteble= stteh u the licosssing of the ejort-ShlJay hesrt valve, wbou iaulry desiga maybava 1od to 300 deetbs, The v=J;ve acaadsl, eoatbin ed etit3s t,tte repcret of women st>fleszrtp s+fter receiying brast implsnts, led so a ssartdowA at the ageneyr iu 191Kt•. Burlington insisss that thb FDA v+iit aontisice to tsview the atediaal offaatiYtaets of new dwieea as well as afery, and thet aotsearas 5=tt ittdust>7 ettperts. , Some esatutlves:ay tktu suols an appreach - siroilar to the etittiwl crisls roquired of new drW - is fnapprapriate to the ds+ica lidd. Walte ehialct more riaorotu testing of devieas ia naoersrry in part becitue davias Were et#atpt trota rayttluian until 1976 snd tegutttions have beelt tnerewng ever sietee. oftert without approptiate inaeases in staEf for the a;onqi. Part of the emttroveay !s one of pttilodophyy many phyllCiaDa ar~ iltat the FD1~ te#titit of eo3tQteriomal utd pnblie baahtns for my failnra, Is saeldna t+ts unraasottable staitdsrd. "'Mry are looldaa for absoiute ufery, and disease is tsot ttfo," sNd Dr.,ntstsur HaW Jr., protaocr of w at *e Bsylor Co1• lasa of l~dicine.' !s Ib not p perfect , wortd. Yot;luve te baJanaa the goad against lbe, b2d„ E,ron usiaS tbousaads of pttiettts iri dirt'sea" ttiala won't ensurE either tafsty or effeetiram ttatt in a world ta+kers I in $,000 tteart ratvea, or veia bttgi.nts or other dev3act might fail SetU endort;es a puadigest onoo ptvposad tr~ a t~ard:tugeptt, tbe Jate D~~Ciht Piuken, nte of iho nstion's flrat .rlto heiped 4151111F tiot~ de~s, Hat~xtt telid, "A tcatb darie~ ia d~t satri than tha dix.ais tor wbioh u;s uaed and is the ten ivaitsble." BeUt mid that, "ibe a4riy heart valvas weta itnperleet, Mort: thatt a rniJiioa peopk tre tbvs today bee.uae they uwd an ittipetfeet „ ,,Akio 'liete is little tsvidanta to show whetttar Eysopeane cuft ftbm 3tttivitt3 looser start• dardt otr taedial devim tl3ttr+e aa no scad• iet tw,asxlq roksive sifety. As ezsa~+ l~a of to+rer anandards iqa Lurope. FDA offkisid eita the thaiidontida saandal of the t3SOs . and tbe 3hosy vOet that was dXuWted in Ettsopa and led to ltwtdreds of deatlsas Sai11'a philoeophy tt sitailar to t1at oEfered by Stttopeia ta~ttiatora, +vho ea~aa to ttttve a atote rmYSfot~bla telatdotssA}p with iniusrry- want them to suaeed," ssid Hsrmvt js+nu=, diteetor of tha Medieal D,epartment•for the Ahoitiattd TUV, the lsrgest medtea] device teetina igeruy,tit Germany. "Wd wsnt to be their paztner, in a sense." Tho nOnpfofiS agency, tome(hing like an UndervvriteR Iabotatory, does i bsoad rattge of setery testing and is supparted with re=uiat~ fees ebarged to industry and aan- sumers,~(fh e(fhe Clintoa adminietratsoot haa otfered a oontrovetaial p:oposal that induz;- try be ehargerl user isea for the cott of azpandittg tbe FaA ttaB to speed approval tittw.) T'LTw hss a staff of doctors and sngituere•+ho do psamarfcet testina, rsgicn~ttivn of deviees usd tequirc repotting of Adverso otttoonea, '1•}tGypride theSlb" 00 CftAnoya8d triiiSt ihat patidats in GerrautY cpn expecs a hig)t lsral of safety ftrnn their ayitem. But'Pyetfa IttSlsts that Eutropearts kave beea exloied to a series of dangerous dritp tUt tiara eat livrs anx the y9tit)s. SVolfa doea not havta dua ors devirx tailurrs in Eiirape ~beyond the Sh7ey valve in eha 19MI), Ut believer Ameticaas nsod tnore proteetinn beSore implanted devieaa oan be tued. Dr. Julitt Swain, a Udiversity et Nevada hesit surjeon, who has aerved on some M4 revie+r,panela, taid she thinks many of the Cotripluau a~tinst theage~n~ey are mcaggerat- ed, but t he addedc "?be FDA ~ too slow. 8nt T think tt>,tt's because the wtsterizaa publioand the teiel establishmeas ue.not tolt+rant of deviet fiihtres." Reoendy, Swain said, FDA rbslllamra, review docton utd a rnanufoeturer worked toaether in >inproxdented coopent;oa to rQb4 throuSb t}se tpproval protast a device -•ealled a stent-•uced to heep coronary eneries (pert. "'13e original etttedior we were given wete awful," sha said., and were turned dom by the FDA advrsotyyattel. "However, in thsee months tbe FT)A helped oome.up with new studies to act the stent fpproved,... T1sa agsttry and the tnaactfscturor got teath{s to blitz a product. JIt felt good:' It is good, stid Jim Beason, a fo:mer sotiag coaQrnissioner of the a;uey who now wotka for indistty. But, hcpo,nts out, the stent isitaatpte tatwliy eoa5smt tt kn3•atattdittp industty complaint: It had been on the rnsr'• kt:t years eat'tier in Europa.

faIM.W. %.634~ ... J echnology can 'lower health costs ..,.~..........I...........•........... ~thout dotsbt, Ameri«rz; ue ~.+asas~y b'sllians of dt~,iss oa higlt tet,hnolosy t7lodiciae. One of evety four high-tsch EoW, prooeduree or ttutS• eria perfomed in the Uaited Statas is ttnneesf• M secardin,a to stndita by and Corp. "About a quener of what •we do we could stop doing and not aHcat paiient heetth; 9sid Robert Srook. d'ttkctor of Rand'i hest( h saeners preptua. 8nt thete's a ditYeretta bet+rrert overindulong in hi3it•teeh praeadut es ictd et>cauragin8 inaavations 10thu, properly employed. an drtatstkaily reduce caea • . A 31 eaillion rttignetir. reeo• ttiace irousitt;' (MRl) asZhine an sa++e thotwnds of daUus by diesrttssin3 twttoss and othor niiments viithottt thv east of surgery sad doys in a htupitst. Other eaurttrtes, with an. ttsliy or~t+nized hedth uuumeA propyau, ue ttsOt+e judistoru tha8 the tlaited Stuee in ohoosing how ntueh new teetaftolcty thoyaart alford. it's a doliate balaaae oi Coiti ttld bCDefiti. flne MR,tmtud7itte in a cornmu- ttiry at+ uvo i stsaS tbr• twtts in wrgiat costs. Sui the Vaited Sptas has 2.400 tnsehaua, raiiini the Wits per patient ind +vssong mil- lieai. KeweY er, tttat doesl+'t ttian U.S. pacidttu ehotakW be deaied MRI tsehnokogy, Wt, regulators otteet do juet thu: delay introduation of teebaotoV thttt an ceye li+res atui rive tniliient of dollttsa, Without tapeain~ t~he abat to irtsli a lead or tt deMb• cia:u arclds ttilat S1Q,G00 or, atopai15,tJ00 itt surte~r btlls and the riaks arsodttad wtth such i trau• at=tie operatiotk t~ortvrrttiotul thorax sutaery oosts the 11ves of 200~pa~ttettts for rvery 1oAt7D who enter the oper- ,cing room. The risk is taue~, tawsr with ttenNe- ttouo leads, which sidestep the need to open a puient's ehaat. "it's not zero," s.d Dr. Robert Hettser, at the MinnezapolisHeart Snati• wse. "But with trartsenous leads, it's con:ideriblY less attd everybody kno++n it." Nevert6e3ois, the food artd DNj in wes so sterw ta approvint atxne itttravenous leads that U.S. pttiente had to undarSo oerte ritky, mvre aotytr q two yeus ettar sasud usht the latou US.-deaig,dedads. - M1ks Meyere One cOmpany's. eXp4rlenCa When Mtedttonlc sought pov®rnn+ent approvv8l tor I trartavenoua ftaeca ut;ed txt its defib:lilattx devioe. tTi, prQOeSS wcs quhe dittareatt tuaro and Overseea. Deabrillatars s:nd elecbia irnpussds to ths t$M to rag• t.ttste the hesr{beat, Tfte "rtsvbnaua leads are aYttail wree that are ttrOteuvered through veins and into t#+e hrart so the impulfes c$n be delNerets e ttie hVr tlow wall. U*g this type of ieacw aliowl;VW Phoicia1 to krtpwtt the dr+ice wftut "cracldng" ihe rib cege to appty >ne,leada to the cva;o* wail oi th® heart. Wer.'s how the approval ptoeers +went: . e O0t, 1U91 Metfuonlc submits bench ta{st Mults ot eerty tsanzven• ous leadg toTUV, a prtvate C3®rman age Mt tests medicai deviow' tiTtC148rVes a!, a regulatory BtACtC%* tor ® Gerrrten ¢ovemtTfent The ed t)y the gevernmsra. agarcy's a,pproaaia are usWally lUbner•e ~nv Nov.18891 TUV lssua= approvai; tesds'commerciauy availabie to German p,atlents. Approtrtl flme: I monft Ntrr/111i;0! Metltronic applied to'rW t~r approval ot tievice ctnrtges. tt7tangee were tr~a in connt3ctora rnak~tg the leads abcut the aame as thoa swDntuady apPW,ed in tl" Unlted $tate6 in Oeo, s9a3.) poe.19S0{ TLitl spproved chtrtge, N type ot leads bet:ame tivs;ilabla to Qerrrtan pa9MS. Appravel me: I manffsr Notet Appraval of the leads tooK plaCe fore Eurapean tJrtlan reQulASions were in pface. Today,'tW tpprovaJ wottd atbw, eommohdal tase of th®ss teads in ern ot the 12 Eur Urtian r1AtlOrts. PreYtouSly, H wasMaceeaary to appy eaparetely to e natlon. . Matoh 19901 MedVtaniC subAfted t" resutts at bench artd labotaA+y teats to the 1=Da autid tequested Inve ''artat Oevice P~cen~ption so trantY@notrs leae~ aoutd be n~sltuted y use in fturrtsM. • oat, ig9CV lrtvettti9attot~l Oevipa ~ prion approved by FDA; tl'inieai tQ3~rp on ttnmart pa3tartts bQ~ . MaraR 1l92/ Medtronic st,tbmitted r (ts af ellniC31 tett" to PDA " reqtsenety Prer~Matksdng Appro*. Apuii 199SJ permisaiort grantQd to ez{}end aknicaj ovalu8tlona. Atag. 'tg93! PDA advisory, p3rteJ met atuS tlnenintously recemmendec that the agQncy approve ttte leads. t"aept;. 19831 leids for+isalty deciasad etuxovable ' ted by FOA. Leads becsrne Dtia. St3W pre-klerketing Approvai g wi' cammertdally awaatke to u.. pWA*tt' SoNr= MqdNOhfO ft. 20469367SO

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