without FAnFArE or lEgislAtion, thE govErnmEnt is orChEstrAting A quiEt rEvolution in how it rEgulAtEs nEw mEDiCinEs. thE rEvolution is BAsED on thE iDEA thAt thE siCkEr pEoplE ArE, thE morE FrEEDom thEy shoulD hAvE to try Drugs thAt ArE not yEt Fully tEstED、For FiFty yEArs govErnmEnt poliCy hAs BEEn DrivEn By AnothEr iDEA: thE FEAr thAt insuFFiCiEntly tEstED mEDiCinEs CoulD CAusE DEAths AnD injuriEs. thE urgEnt nEEDs oF pEoplE inFECtED with hiv, thEAiDs virus, AnD thE possiBility oF mEEting thEm with nEw Drugs hAvE CrEAtED A CompElling CountErvAiling ForCE to thE Continuing ConCErn with sAFEty.As A rEsult, govErnmEnt rulEs AnD prACtiCEs hAvE BEgun to ChAngE.EACh stEp is ControvErsiAl.But thE shiFt hAs AlrEADy gonE FAr BEyonDAiDs. nEw wAys ArE EmErging For vEry siCk pEoplE to try somE ExpErimEntAl Drugs BEForE thEy ArE mArkEtED、pEoplE with thE most sErious Forms oF hEArt DisEAsE, CAnCEr, EmphysEmA,AlzhEimEr’ s or pArkinson’ s DisEAsE, multiplE sClErosis, EpilEpsy, DiABEtEs, or othEr grAvE illnEssEs CAn rEquEst suCh Drugs through thEir DoCtors AnD ArE likEliEr to gEt thEm thAn thEy woulD hAvE BEEn Four yEArs Ago. "wE’vE BEEn too rigiD in not mAking liFEsAving Drugs AvAilABlE to pEoplE who othErwisE FACE CErtAin DEAth," sAys rEprEsEntAtivE hEnry wAxmAn, oFCAliForniA, who hEADs thE suBCommittEE thAt ConsiDErs ChAngEs in Drug-ApprovAl poliCiEs. "it’s truE oFAiDs, But it’s Also truE oF CAnCEr AnD othEr liFE- thrEAtEning DisEAsEs."
For thE First timE, DEspErAtE pAtiEnts hAvE BEComE A potEnt politiCAl ForCE For mAking nEw mEDiCinEs AvAilABlE quiCkly. pEoplE withAiDs AnD thEir ADvoCAtEs, youngEr AnD AngriEr thAn most hEArt-DisEAsE or CAnCEr pAtiEnts, ArE DrAwing on two DECADEs oF gAy ACtivists’ suCCEss in orgAnizing to gEt whAt thEy wAnt From politiCiAns.At timEs thEy FounD thEmsElvEs AlliED with rEAgAnADministrAtion DErEgulAtors, sCiEntists, inDustry rEprEsEntAtivEs, FD
A、stAFF mEmBErs, AnD sympAthEtiC mEmBErs oFCongrEss. thEy orgAnizED thEir own CliniCAl triAls AnD sEArChED out promising Drugs hErE AnD ABroAD、thE rEsult is A FAmiliAr wAshington story: A Crisis—AiDs—hElpED CrystAllizE An inFormAl CoAlition For rEForm.
AiDs gAvE nEw powEr to olD ComplAints.As EArly As thE 1970s thE Drug inDustry AnD somE inDEpEnDEnt AuthoritiEs worriED thAt thE FooD AnDDo, gADministrAtion’ s tEsting rEquirEmEnts wErE so DEmAnDing thAt nEw Drugs wErE BEing unrEAsonABly DElAyED、BEginning in 1972, sEvErAl stuDiEs inDiCAtED thAt thE unitED stAtEs hAD lost its lEAD in mArkEting nEw mEDiCinEs AnD thAt BrEAkthrough Drugs—thosE thAt show nEw promisE in trEAting sErious or liFE-thrEAtEning DisEAsEs— hAD ComE to BE AvAilABlE muCh soonEr in othEr CountriEs. two high-lEvEl Commissions urgED thE EArly rElEAsE oF BrEAkthrough Drugs. so DiD thECArtErADministrAtion, But thE lEgislAtion it pro- posED DiED inCongrEss.ComplAints wErE CompounDED By growing ConCErn thAt "iF wE DiDn’t strEAmlinE poliCiEs, rED tApE wot, iD BE An oBstAClE to thE DEvElopmEnt oF thE BiotEChnology rEvolution," As FrAnk
E、young, who wAs thE hEAD oF thE FD
A、From 1984 to 1989, put it in An intErviEw with mE.
young wAs A kEy FigurE in thE ovErhAul oF thE FDA’s poliCiEs.
A、pionEEr in BiotEChnology AnD A FormEr DEAn oF thE univErsity oF roChEstEr’s mEDiCAl sChool, hE CAmE to wAshington with An AgEnDA AnD hEADED thE AgEnCy For FivE AnD A hAlF yEArs—longEr thAn AnyonE ElsE hAs sinCE thE 1960s. young took thE FD
A、joB to hElp introDuCE nEw mEDiCinEs CrEAtED By BiotEChnology-- whosE promisE hE hAD sEEn in his own gEnE-Cloning lAB--AnD to gEt ExpErimEntAl mEDiCinEs to DEspErAtEly iii pEoplE morE quiCkly. hE hAD sEEn pEoplE DiE wAiting For nEw mEDiCinEs BECAusE "thEy wErE in thE wrong plACE At thE wrong timE," hE sAiD、thAt is now ChAnging.
During his tEnurE oF oFFiCE As hEAD oF thE FDA, FrAnk
E、young______.
A、hAD A BittEr ArgumEnt with his CollEAguEs ovEr thE ovErhAul oF Drug-ApprovAl poliCiEs
B、plAyED A lEADing rolE in rEConstruCti