E-United States, umlando wokukhulelwa kwezimo eziphuthumayo uye wabangela ukuphikisana , kwagxila izingxabano zezombangazwe futhi kwaveza amacala. Imvelo evuthayo yokukhulelwa kwezimo eziphuthumayo ingenxa yokuthi kungakhathaliseki ukuthi abantu bakholelwa yini ukuthi imishanguzo ye-morning-emva iyakwenza ukuvimbela ukukhulelwa kungenzeki noma ngabe sekuqeda ukukhulelwa okwakhiwe kakade.
Hlela B Isinyathelo Esinye (isib., Iphilisi ekuseni) emva kokuvame ukudideka ne- RU486 (okungukuthi, iphilisi yokukhipha isisu). Le mithi emibili ayifani futhi isebenza ngokuhluke ngokuphelele uma kuziwa kwinkqubo yokukhiqiza.
Kungakhathaliseki ukuthi yiziphi izinkolelo zakho, umlando wokukhulelwa kwezimo eziphuthumayo kanye nokugunyazwa kwawo kwe-FDA e-US bekulokhu uhambo oluyinkimbinkimbi. Izimpande zesimanje zokukhulelwa eziphuthumayo zanamuhla zingabuyiselwa emuva kwizifundo zesilwane ngawo-1920, kodwa ukusetshenziswa kwabantu kwaqala ngawo-1960. Ngakho buckle up, lokhu kungaba ukuhamba bumpy ...
Isikhathi Sesikhathi: Umlando Wokukhulelwa Okuphuthumayo
- Maphakathi nawo-1960: Ukwelashwa okuphuthumayo kwasetshenziswa njengendlela yokwelapha izisulu zokudlwengula ukuvimbela ukukhulelwa okungalindelekile . Odokotela babezobeka umthamo omkhulu we-estrogen ngemuva kokudlwengula. Yize lokhu kutholakala ukuthi kusebenza kahle, kwakukhona nemiphumela emibi kakhulu emibi.
- Ekuqaleni kwawo-1970: Kwafakwa uhlelo lwe-Yuzpe, olwakungamakhemikhali ama- hormone ehlanganisiwe futhi lushintsha izindlela zokwelapha eziphuthumayo zesifo esiphuthumayo se-estrogen yama-1960.
- Ngasekupheleni kuka-1970: Odokotela baqala ukunikela nge- copper IUD njengeyona ndlela kuphela ye-hormonal yokuzivocavoca okuphuthumayo.
Ukuhamba Okusheshayo Eminyakeni Eyishumi ...
- Ngo-February 25, 1997: Ngenhloso yokugqugquzela abakhiqizi ukwenza izinkinga zokukhulelwa eziphuthumayo zitholakale, i-FDA ibhaliswe kwiRejista yaseFranshini eyenziwe nguKhomishana, "iphetha ngokuthi ezinye zokuvimbela izisu zomlomo eziqukethe i- ethinyl estradiol ne- norgestrel noma i- levonorgestrel ziphephile futhi zisebenza ngendlela ukukhulelwa okuphuthumayo kwe-postcoital " nokuthi i-FDA icela " ukuthunyelwa kwezicelo ezintsha zezidakamizwa kulolu hlelo lokusebenza. "
I-ejensi yanezela ukuthi iyavumelana neKomiti Yezokuqondisa ye-FDA ka-June 28, 1996, ephethe ngokuvumelana ngokuvumelana nokuthi ukusetshenziswa kwezilawuli ezine ze-hormone kungasetshenziswa ngokuphepha futhi kusetshenziswe ngendlela ephuthumayo njengokukhulelwa kwezimo eziphuthumayo - ukunikeza imvume ye-"off-label" ukusetshenziswa okuphuthumayo kokukhulelwa komzimba amaphilisi okulawula ukuzalwa ane -00 mg ye-ethinyl estradiol kanye ne-50 mg ye-norgestrel (amaphilisi amabili manje / amaphilisi amabili emahoreni angu-12); .03 mg ye-ethinyl estradiol kanye no -30 mg we-norgestrel (amaphilisi amane manje / 4 emahora angu-12) ;. 03 mg we-ethinyl estradiol no -5 we-levonorgestrel (amaphilisi amane manje / 4 emahoreni angu-12); futhi .03 mg ye-ethinyl estradiol kanye no -125 mg we-levonorgestrel (amaphilisi amane manje / 4 emahoreni angu-12). Ngaleso sikhathi, i-FDA inikeze imiyalo yokuthi amaphilisi alandelayo angasetshenziswa kanjani njengezinkinga zokukhulelwa eziphuthumayo: Ovral, Lo / Ovral, Nordette, Levlen, Triphasil, no-Tri-Levlen.
Kodwa-ke, i-FDA iphinde yaphawula, esitatimendeni se- Federal Register , ukuthi iphikisana nesicelo sezakhamizi kaNovemba 1994 ecela i-ejensi ukuthi ivumele abakhiqizi bezinhlanganisela ezithile zokulawula ukubeletha ukushintsha amalebula abo ukufaka imiyalelo yokuthi bangasebenzisa kanjani lawo maphilisi njengemithi yokwelashwa okuphuthumayo .
- Ngo-September 2, 1998: I-Kit Prevention Emergency Contraception Kit yaba umkhiqizo wokuqala ovunyelwe yi-FDA ngokuqondile ngokukhulelwa kwezimo eziphuthumayo. Ukuhlonyiswa emva komthetho we-Yuzpe, i-Preven Emergency Contraception Kit (Preven Emergency Contraception Kit) iqukethe ukuhlolwa kokukhulelwa komchamo, isinyathelo esinezinyathelo "Incwadi Yokwaziswa Kwamalunga" kanye namaphilisi amane (ngalinye eliqukethe i-0.25 mg ye-levonorgestrel ne-0.05 mg ye-ethinyl estradiol) - 2 kuthathwe ngokushesha futhi 2 kuthathwe amahora angu-12 kamuva. {* Qaphela: le kit ayisatholakali.}
- NgoJulayi 28, 1999: I-FDA ivunyelwe uhlelo lwe-B njengendlela yokuqala yokwelashwa okuphuthumayo etholakala e-US.
- NgoFebruwari 14, 2001: Isikhungo SamaLungelo Okuzala sifaka isicelo se-Citizen Petition nge-FDA egameni lezinhlangano zempilo ezingaphezu kuka-70 zezokwelapha nezomphakathi ukwenza i-Plan B etholakalayo ngaphezulu kwe-counter.
- Ngo-Ephreli 21, 2003: I- Barr Laboratories (okwakhiwa ngaleso sikhathi, i-Plan B) ithumela isicelo ne-FDA ukushintsha iSuhla B kusukela ekubhaleni ukuya esimweni esingabhalwanga.
- December 2003: Isicelo kanye nedatha ezivela ezingeni ezingaphezu kuka-40 zabuyekezwa ngamakomidi amabili e-FDA okweluleka, ikomidi lezokwelapha zezokwelapha kanye nekomidi le-Nonprescription Drugs, bonke abavumelana ngokuvumelana ukuthi uhlelo lweB B lwaluphephile futhi lusebenza kahle. Iphaneli le-FDA livoti 23-4 ukutusa ukuthi iPulani B ithengiswe phezu kwe-counter. Abasebenzi be-FDA abaqeqeshiwe, kuhlanganise noJohn Jenkins, oyinhloko yehhovisi lika-FDA's New Drugs, nabo bavumelana nesincoma.
Cishe 6 Izinyanga Kamuva ...
- May 2004: I-FDA yakhipha incwadi eya ku-Barr Laboratories, iphika isicelo se-OTC yokuthengisa yenkampani futhi icaphuna ukukhathazeka mayelana nokuziphatha kwentsha nokuziphatha ngokocansi. Lesi sinqumo senziwe naphezu kwezifundo ezikhombisa ukuthi ukusetshenziswa kwePlani B akuzange kwandise ukuziphatha kabi noma kuguqulwe ukusetshenziswa kwabesifazane kwezinye izindlela zokulawula ukubeletha . Lokhu kuqhutshwa yi-FDA ukungazibali idatha yesayensi kanye nemibono yobuchwepheshe kuholele umlilo emphakathini wesayensi. I-American College of Obstetricians kanye namaGynecologists wabiza lesi sinqumo ngokuthi "ukuziphatha okubi" futhi "ibala elimnyama ekudunyeni kwe-ejensi esekelwe ebufakazini njengo-FDA."
- NgoJuni 15, 2004: AmaSenenja uPatty Murray noHillary Clinton bacela ukuthi iHhovisi eliPhezulu lokuPhatha (GAO) liqalise ukuhlolwa kwe-FDA kaMeyi 2004 ukwenqatshelwa kwesicelo seBarr Laboratories ukwenza i-Plan B itholakale ngaphandle kwemithi.
- July 2004: I- Barr Laboratories ithumele uhlelo olubuyekeziwe oluhambisana nesincumo se-FDA sokufuna isimo se-OTC kuphela sabesifazane abaneminyaka engu-16 nangaphezulu. Amalungiselelo e-FDA ngesinqumo sokwenziwa ngoJanuwari.
- Ngo-Agasti 2004: Isihloko sokubuyekezwa kokuphuthumayo sokubeletha kokubeletha emaphephandabeni, i- American Family Physician ichaza ukuthi "i-FDA isuse imikhiqizo engu-13 yemithi yokwelapha ngomlomo ngokuphepha nokusebenza uma isetshenziselwa ukukhulelwa okuphuthumayo" futhi yanezela i-Alesse, Levlite, Levora, Trivora, Ogestrel, Low I-Ogestrel, ne- Ovrette eya ku-February 1997 i-FDA uhlu lwamaphilisi angasetshenziswa njenge-label-off label.
I-Plot Thickens ngo-2005 ...
- NgoJanuwari 2005: I-FDA yayingakaze isenze isinqumo ngohlelo lokusebenza olubuyekeziwe lweBarr Laboratories. Ngalesi sinqumo, uSenators uPatty Murray noHillary Clinton babambe iqhaza ekuphakanyisweni kukaLester Crawford ukuba bakhonze njenge-FDA Commissioner. Isikhungo SamaLungelo Okubeletha futhi sifaka icala ngokumelene ne-FDA ngokuhluleka ukuhlangabezana nezikhathi zokugcina zikaJanuwari nokungahoxisi isayensi nokubamba uhlelo lweB B kumgangatho ohlukile kunezinye izidakamizwa.
- NgoJulayi 2005: USeninkulu uClinton noMurray baphakamise uCrawford (ozoqinisekiswa yiSénate) ngemuva kokuba uNobhala WezeMpilo noMnyango WezeMisebenzi uMichael Leavitt uthembisa ukuthi i-FDA izokwenza isinqumo ngo-September 1, 2005.
- Ngo-Agasti 26, 2005: Esikhundleni sokumemezela isinqumo ngesicelo esibuyekeziwe, i-FDA ihlehlise isinqumo sayo, ifuna ukuvumela ukufakelwa komphakathi. UKhomishana uCrawford wavuma ukuthi "idatha ekhona yesayense inokwanele ukusekela ukusetshenziswa okuphephile kwePlani B njengomkhiqizo ophezulu," kodwa i-FDA ihlulekile ukuvumela ukutholakala kwe-OTC, esikhundleni sokukhetha ukuhlehlisa isinqumo futhi. UCrawford uthe le nhlangano ayikwazanga ukuthola isinqumo mayelana nokuvunyelwa kwesicelo kuze kube yilapho "izinkinga ezingavunyelwe ukulawulwa nezinqubomgomo" zingabuyekezwa kabusha. Ngisho noma iphaneli lobuchwepheshe be-FDA liye lavuma isimo se-OTC sePlathi B ngamvoti angu-23 kuya ku-4, uCrawford usanquma ukwedlula iphaneli lakhe futhi ugcine uhlelo lweBhodi njengemithi kadokotela.
- USepthemba 1, 2005: Umsizi we-FDA uMkhomishana wezeMpilo yabesifazane, uDkt. Susan Wood ushiye ukuphikisana nesinqumo sikaCrawford sokubambezeleka kokuthatha izinqumo. UDkt. Wood uthi "abasebenzi bezesayensi [e-FDA] bavalwa ngaphandle kwalesi sinqumo" nokuthi isimemezelo sikaCrawford, "saba nokuphazanyiswa okungavumelekile ekuthathweni kwezinqumo." Inkhulumomphendvulwano eyalandela, uDkt. Woods wachaza ukuthi bangaki ozakwabo "bakhathazeke ngokujulile ngokuqondiswa kwe-ejensi," futhi kwi-imeyli eya kubasebenzi base-FDA nabasebenzi, walungisa ukuyeka kwakhe ngokusho ukuthi, "akakwazi ukukhonza njengabasebenzi uma ubufakazi besayensi nobuchopho, buhlolwa ngokugcwele futhi buphakanyisiwe ukuze kuvunywe ngabasebenzi abaqeqeshiwe lapha, kuye kwachithwa. "
- NgoSeptemba 9, 2005: USenators Murray noClinton, manje ojoyina osebenza nabo abangu-11 eSenate Senate wase-United States, bacela i-United States GOA ukuba bakhulule ukufundwa kophenyo lwabo ukuhlola ukukhishwa kwe-FDA kwesicelo se-Plan B. Encwadini yabo eya ku-GAO, izintshumayelo ziveza ukukhathazeka ukuthi sekuyiminyaka engaphezu kwemibili, kanti i-FDA iyaqhubeka iphuza isinqumo se-Plan B. Lokhu kukhathazeka kwanikezwa ngokuthi izinhlangano ezinkulu zezokwelapha ezingaphezu kuka-70 zisekela ukusetshenziswa kwe-OTC ye-Plan B, ukutholakala kwedatha yesayensi etholakalayo ukusetshenziswa okuphephile kwePlani B njengomkhiqizo we-OTC, futhi ikomidi lezeluleko lezesayensi ye-FDA livote kakhulu ngokuvumelana nomkhiqizo i-OTC etholakalayo. I-senators ibhala, "Lokhu kuguquka kwezehlakalo kushiya ukuqina okukhulu okukhathazayo mayelana nezombangazwe kuye kwaqeda ukukhathazeka mayelana nempilo yomphakathi kule nqubo."
- September 24, 2005: Ezinyangeni ezimbili kuphela emva kokuqinisekiswa, uKhomishana uCrawford ushiye.
- Okthoba 2005: UDkt. Frank Davidoff, owayenguyilungu leKomiti Yezincomo Zokungabonisi Izidakamizwa, uphinde wasula ngokubhikisha. I- New England Journal of Medicine yakhipha isihloko sayo sesibili, isishaja i-FDA ngokwenza "ukuhleka inqubo yokuhlola ubufakazi besayensi." I-GAO ibiza ukuphathwa kwe-FDA kwePlani B "okungavamile kakhulu," kucela uSen. Clinton ukuba aphawule ukuthi lo mbiko "ubonakala uqinisekisa lokho esikusolile okwesikhashana: Isayensi yenzeke esimweni senqubo ye-FDA yokwenza izinqumo kuPulani B."
U-Whew ... u-2005 wawunzima kakhulu emlandweni wokukhulelwa kokuphuthumayo. Unyaka ka-2006 usilondolozephi iphilisi ekuseni?
2006 kuya ku-2013
- Ngo-March 2006: U- Andrew von Eschenbach, umngane kanye nodokotela kaGeorge W. Bush, uthathelwe esikhundleni sokuba abe nguCrawford futhi wakhethwe ukuba abe ngu-Acting Commissioner. Ngaphansi kokuhlala kwakhe, washicilela ishidi langempela elixhumanisa ukukhipha isisu nomdlavuza webele. AmaSenenja uClinton noMurray bavimbela ukuqinisekiswa kukaVon Eschenbach njengomkhomishana we-FDA elinde isinqumo sePlani B.
- NgoJuni 9, 2006: I-FDA iphika isikhalazo seKhabhinethi ka-2001 okokuqala.
- UJulayi 2006: I-FDA ithi imithetho emisha ayidingekile, futhi ngosuku olulandelayo ngaphambi kokumangalelwa kwakhe, u-Commissioner we-FDA u-Andrew von Eschenbach ememeza obala iBarr Labs ukuba aguqule futhi aphinde athumele isicelo sakhe ngokushintsha ukuvinjelwa kweminyaka ye-OTC ye- Plan B kuya kwezingu-18 nangaphezulu .
- Ngo-Agasti 24, 2006: I-FDA yamemezela ukuvunyelwa kwayo kokuthengiswa kwePulani B OTC kulabo abaneminyaka engu-18 nangaphezulu kanti labo abangaphansi kweminyaka engu-18 besadingeka ukuthi badinga imithi ukuze bathole le ndlela yokukhulelwa okuphuthumayo.
- November 2006: U- Barr waqala ukuthumela amaphakheji angenaprescription wePulani B kuma-pharmacy ngaphesheya kwe-US.
Iminyaka emibili edlulele phambili ...
- NgoDisemba 23, 2008: I- Teva Pharmaceutical Industries imemezela ukuthi kutholakala iBarr. I-Plan B manje idayiswa yi-Duramed Pharmaceuticals, insizakalo yeTeva.
Futhi i-Saga iyakhuphuka futhi ngemva kwezinyanga ezintathu ...
- Ngo-Mashi 23, 2009: E- Tummino v. Torti , iJaji leNkantolo yaseJaji u-Edward Korman wayala i-FDA ukuba ivumele ama-17 ubudala ukuba athenge i-Plan B OTC ngaphansi kwezimo ezifanayo ukuthi zase zikhona kakade kwabesifazane abaneminyaka engu-18 nangaphezulu. Abaphikisi kuleli cala baligcina ukuthi ukulahlwa kuka-FDA kwesicelo se-Citizen Citizen sika 2001 " kwakungabonakali futhi kungenangqondo ngoba kwakungeyona umphumela wezinqumo zokwenza izinqumo ezifanele." UJaji Korman wavuma futhi wathi ukucabanga kuka-FDA akukho ukwethembeka nokuthi i-ejensi ibeka ezombusazwe ngaphambi kwempilo yabesifazane. Wabuye wacela i-FDA ukuthi iphindze iphinde icabange ngokuphika kwayo isicelo seZindlu.
- Ngo-Ephreli 22, 2009: Ngenxa yokuthi i-federal order order iyala i-FDA ukuthi ivumele ama-17 ubudala ukuba athenge i-Plan B, i -FDA idibanisa wonke umuntu ngokumemezela ukuthi labo abaneminyaka engu-17 bangathenga i-Plan B OTC. Kodwa, lesi simemezelo sasiyi-FDA esimemezela ukuthi sazise umenzi wePlani B ukuthi inkampani ingaba, ngokuthumela nokuvunyelwa kwesicelo esifanele , iMakethe yeBanethi ngaphandle kwemvume yabesifazane abaneminyaka engu-17 ubudala nangaphezulu. Lesi simemezelo sibangela ukuthi ukuphulwa kokuphuthumayo okuphuthumayo kubuyele emuva ekukhanyeni.
- NgoJuni 24, 2009: I-FDA ivumela ukusetshenziswa komuthi kuphela we- Next Choice , uhlobo olujwayelekile lwe-Plan B.
- NgoJulayi 13, 2009: I-FDA yamemezela ukuvunyelwa kwePlani B-Isinyathelo esisodwa (iphilisi elilodwa lomthamo kanye ne-version entsha ye-Plan B). Ngalesi sikhathi, i-FDA nayo ikhulise ngokusemthethweni ukufinyelela kwe-OTC, evumela abesifazane nabesilisa abaneminyaka engu-17 noma ngaphezulu ukuthi bathenge i- Plan B Isinyathelo Esinye Esimeni se-ekhemisi ngaphandle kwemithi ekuqinisekiseni ubudala (labo abangaphansi kweminyaka engu-17 badinga imithi).
- Ngo-Agasti 28, 2009 : I-FDA ivumela ukuthengiswa kwe-OTC ye-Next Choice, uhlobo olujwayelekile lwe-Plan B, kubo bonke abaneminyaka engu-17 noma ngaphezulu (amantombazane angu-16 nabancane badinga imithi yokuthola imithi ukuthola i-Next Choice).
- Ngo-September 2009: Uhlelo lwe-B One-Step luyatholakala kuma-pharmacies athengisa yonke indawo, nokukhiqiza izitoreji ze-Plan B ezindala.
2009 kubonakala sengathi unyaka omkhulu emlandweni ophuthumayo wokubeletha. Ake siqhubekele phambili cishe ngonyaka owodwa ...
- Ngo-Agasti 16, 2010: I- FDA inikeza imvume yokugcina yokubeletha okusha okuphuthumayo, u-Ella . I-Ella itholakale kuphela ngemithi yesiguli futhi itholakale kuma-alfabhethi azungeze ngoDisemba 2010. Isebenza ngokuhluke kakhulu kunePlani B Isinyathelo Esinye.
Manje, Lungela Ngo-2011 (Ubeka Ignite, Once Again) ...
- Ngo-Ephreli 7, 2011: I- Teva Pharmaceuticals ifake isicelo sokusebenzisa izidakamizwa ezintsha nge-FDA icela ukuthi uhlelo lwe-B B One Step lithengiswe phezu kwe-counter, ngaphandle kwemingcele yobudala (futhi kufaka idatha eyengeziwe eqinisekisa ukuphepha kwayo yonke iminyaka yokusebenzisa).
- NgoDisemba 7, 2011: I-FDA inqume ukunikeza isicelo seTeva Pharmaceutical sokuphakamisa yonke imingcele yeminyaka futhi ivumele uhlelo lwe-Plan B One-to-counter, ngaphandle kwemithi. Kodwa-ke , ekuhambeni okungakaze kwenziwe ngaphambili, uMnyango WezeMpilo kanye Nezinsizakalo Zomuntu uNobhala uKe Kathleen Sebelius upheqa ukugunyazwa kwe-FDA futhi wayala le nhlangano ukuba iphike isicelo seTeva. I-Sebelius ikhipha idatha enganele yokweseka ukuvumela i-Plan B One Step ukuthi ithengiswe phezu kwe-counter kuwo wonke amantombazane eneminyaka yokuzala. Uphinde wachaza ukuthi amantombazane aseneminyaka engu-11 ayakwazi ukuthola izingane futhi azizwa sengathi uTeva ubonise ukuthi amantombazane amancane angakwazi ukuqonda kahle indlela yokusebenzisa lo mkhiqizo ngaphandle kokuqondiswa kwabantu abadala. Lesi sinqumo sigcizelele izidingo zamanje ezihleliwe ezihleliwe ezihleliwe (Plan B One Step) kanye ne-Next Choice). Kumele zithengiswe ngemuva kokubala kwe-pharmacy ngemuva kokuba umuthi wemithi angaqinisekisa ukuthi umthengi uneminyaka engu-17 ubudala noma ngaphezulu. NgoDisemba 12, 2011: I-FDA iphika isikhalazo se-Citizen Petition futhi , isenza icala likaTummino v. Hamburg liphinde livuliwe ngoFebhuwari 8, 2012.
Ngakho-ke, unyaka ka-2012 uqala ngecala lezinkantolo lapho abaphikisi befake isicelo sokuvinjelwa kokuqala okuzovumela ukutholakala kwe-OTC kuwo wonke ama-contraceptive asekelwe e-levonorgestrel (kokubili izinguqulo zamaphilisi amabili) ngaphandle kwanoma yimiphi imikhawulo yobudala noma indawo yokuthengisa. ..
- Ngo-Febhuwari 16, 2012: Ijaji iKorman likhuluma ngokuthi "I-Order Yokubonisa Imbangela" efuna ukwazi ukuthi kungani i-FDA ingabhekiswa ukuba kwenziwe i-Plan B etholakalayo kulabo bantu abafundiswa yi-FDA ukubonisa ukuthi bayakwazi ukuqonda uma ukusetshenziswa Hlela B kufanelekile futhi imiyalelo yokusetshenziswa kwayo. "
- Ngo-Mashi 9, 2012: Amafayela we-Teva isicelo sokulungiswa ukwenza i-Plan B Isinyathelo esisodwa sitholakale ngaphandle kwemithi kubasebenzisi abaneminyaka engama-15 nangaphezulu futhi ukuvumela ukuba kutholakale esigabeni sokuhlela umndeni sekhemisi (kanye namakhondomu , i- Today Sponge , i-spermicide , ikhondomu yabesifazane , kanye namafutha ) kunokuba ngemuva kwe-counter-pharmacy counter, kodwa ubufakazi bokuthi ubudala buzodingeka lapho kuhlolwa.
- NgoJulayi 12, 2012: I-FDA ivumela ukusetshenziswa kokuphuza kokuphuthumayo kwe- Next Choice One Dose , ithebhulethi elilodwa elilinganayo elilingana ne-Plan B One-Step, kanye nezibonelelo ze-OTC / ngemuva kwesimo sokuphikisana ne-pharmacy kulabo abaneminyaka engu-17 ubudala noma ngaphezulu ngaphandle kwemithi.
Futhi ngalokhu, ngikuhola unyaka ka-2013, kanye nesiphetho somlando wokukhulelwa kokuphuthumayo, nohambo lwalo olude nolunzima lokufika lapho lukhona namhlanje ...
- Ngo-Febhuwari 22, 2013: I-FDA ivumela ukusetshenziswa kwe- My Way , okuyi-tablet eyodwa efana ne-Plan B One-Step, kanye nezibonelelo ze-OTC / ngemuva kwe-counter countermacy isimo kulabo abaneminyaka engu-17 ubudala noma ngaphezulu ngaphandle kwemithi.
- Ngo-Ephreli 5, 2013: Ijaji lesifunda sase-US u-Edward R. Korman lishintsha isinqumo se-FDA sokuphika isikhalazo sezakhamuzi kanye nemiyalo yokuthi le nhlangano inezinsuku ezingu-30 zokuvumela ukuthengiswa kwe-contravative eziphuthumayo ezingekho ngaphansi kweminyaka. Wabeka izinqumo zikaNobhala Sebelius ngokuthi "ukugqugquzela kwezombusazwe, ukungaqondani kwezombusazwe, nokuphambene nenhlangano yangaphambili." UJaji Korman uphinde wamangalela i-FDA ngenxa yokulibaziseka okungenacala, egcizelela ukuthi sekuyiminyaka engaphezu kwengu-12 kusukela kuFacebook Petition.
- Ngo-Ephreli 30, 2013: Usuku noma ezimbili ngaphambi kokuba i-ejenti ingadingeka ukuba ihambisane no-Ephreli 5, 2013, inkantolo yamacala, i- FDA "ngokushelelayo" ivumela uhlelo lokusebenza oluhlelwe nguTeva , lugunyaze ukuthengiswa kwePlani B Isinyathelo esisodwa eshalofini ngaphandle imithi yabesifazane abaneminyaka engu-15 nangaphezulu. Ukulondoloza ngokuqinile ukuthi kuvunyelwe uhlelo lweTeva "luzimele ngaphandle kwalolu cala" futhi "isinqumo sabo asihloselwe ukubhekana nesinqumo sejaji." Kungenzeka ukuthi i-FDA inikeze isicelo seTeva ngalesi sikhathi? Hmm?
- May 1, 2013: Izinsuku ezimbalwa ngaphambi kokuthi i-FDA izobe ihambisane nesinqumo seJaji uCorman sika-Ephreli 5, uMnyango Wezobulungiswa wase-United States ucela futhi ucele ukuhlala kwakhe, ngakho-ke i-FDA ngeke itholakale enecala enkantolo.
- Ngo-May 10, 2013: Ijaji uKorman liphika isicelo se-DOJ sokuhlala , kubiza lesi senzo "singenangqondo" kanye nomunye umzamo we-FDA ukulibazisa inqubo yokwenza izinqumo.
- Ngo-Meyi 13, 2013: UMnyango Wezobulungiswa ufaka isicelo sakhe eNkantolo Yesibili Yokudluliswa Kwezikhalo eNyuvesi yaseManhattan. Inkantolo idlulisela isikhathi sokuqulwa kukaJaji Korman kuze kufike uMeyi 28, 2013.
- NgoJuni 5, 2013: Ijaji le-3 likhalela inkantolo ukuphika ukunyuswa kwe-DOJ yokuhlala nokuyala ukuphakamisa yonke imingcele yeminyaka futhi uvumele isimo esiphezulu sokubamba imithi ngamaphilisi amabili okukhulelwa kokuphuthumayo, kodwa hhayi ngokuphuthumayo kwepilisi eyodwa Ukuvimbela ukukhulelwa kwemithi - Ijaji likaKorman lika-pill elilodwa oluphuthumayo lokukhulelwa ngokweqile liye lavinjelwa okwesikhashana ulinde umphumela wesicelo se-DOJ.
- NgoJuni 10, 2013: I- DOJ yehlisa isikhalazo sayo futhi iyavuma ukuhambisana nokuthengiswa kwe-OTC okungavinjelwe kwe-Plan B Isinyathelo esisodwa uma nje ama-generics ehlala evinjelwe ubudala futhi engezansi. I-FDA iphinde icele uTeva ukuba afake isicelo sokufaka isicelo sokufaka isicelo semingcele yobudala noma yokuthengisa.
Isigubhu siza sicela ... umzuzwana emlandweni ophuthumayo wokukhulelwa komzimba esiwuholele ku - YEBO, kuphelile lapha ...
- Juni 20, 2013: I-FDA ivumela iPulani B Enye-Isinyathelo sokuthengisa ngaphezulu kwe-counter ngaphandle kwemingcele yobudala. Le nhlangano iphinde inikeze iTeva iminyaka emithathu kuphela yokuthengisa i-Plan B One-Step OTC. Abakhiqizi bama-1-pilisi ama-generic equals bangathumela izicelo ze-FDA ezengeziwe zokuthengisa okungaphezulu kwe-counter ngemuva kokuthi i-patent ye-Teva iphelelwa ngo-Ephreli 2016.
- NgoFebruwari 25, 2014: Ngomzamo wokuvumela isimo se-OTC se-Next Choice One Dose ne-My Way (izindlela zokukhiqiza ezi-1-pilill zokuhlela i-One-Step), i- FDA ithumela incwadi kubakhiqizi bale mikhiqizo echaza ukuthi Isiphakamiso se-Teva sokuba ubunye "sinqanda kakhulu" futhi "siningi kakhulu." I-ejensi yavuma ukuthi lezi zindlela ezijwayelekile zithengiswa ngaphandle kokudayiswa noma imingcele yeminyaka ngaphansi kwesimo sokuthi abakhiqizi babonisa ekhiqizweni lomkhiqizo ukuthi ukusetshenziswa kwalezi zindlela zokukhulelwa eziphuthumayo kuhloswe kwabesifazane abaneminyaka eyi-17 nangaphezulu. Ukufakwa kwalokhu okusetshenzisiwe kulelo phasela kuphakamisa ukusebenzisana kukaTega kuphela futhi kuvumela ukuthi lezi zindlela ezijwayelekile zithengiswe phezu kwe-counter, ngaphandle kwemigomo noma izidingo zomdala.
Umlando wokukhulelwa kwezimo eziphuthumayo uhlanganisa ukunqoba okuphawulekayo nokunye ukunqoba. Ekugcineni, ukutholakala kwalesi sokukhulelwa okubalulekile kusebenza njengethuluzi elilodwa ekuvikeleni ukukhulelwa okungahleliwe nokukhipha isisu.
Imithombo:
UMnyango wezeMpilo kanye nezinsizakalo zabasebenzi. "Imikhiqizo yezidakamizwa zemithi; Ezinye ezithintekayo zokubeletha zomlomo ezisebenzisayo njengezindlela zokukhulelwa eziphuthumayo ze-postcoital "; Isaziso. I-Federal Register . NgoFebhuwari 25, 1997; vol 62: no 37: 8610-8612. Ifinyelele ngo-10/11/12.
DG Weismiller. "Ukwelashwa Okuphuthumayo." Umhlengikazi waseMelika waseMelika . 2004 Aug 15; I-Vol. 70 (4): 707-714. Ifinyelele ngo-10/11/12.
I-FDA Newsroom. [Agasti 26, 2005]. "I-FDA Ithatha Isinyathelo Kuhlelo B." Isitatimende sikaKhomishini we-FDA uLester M. Crawford. Ifinyelele ngo-10/11/12.
I-FDA Newsroom. [Apreli 30, 2013]. "I-FDA ivumela uhlelo lokukhulelwa oluphuthumayo lwe-Plan B olulodwa olulodwa ngaphandle kwemithi yabesifazane abaneminyaka engu-15 ubudala nangaphezulu." Kufinyelele ngo-10/11/12.
J. Trussell, F. Stewart, F. Guest, no RA Hatcher. "Amaphilisi Okuphuthumayo Okuphuthumayo: Isiphakamiso Esilula Sokunciphisa Ukukhulelwa Okungahle Kulindeleke." Izinhloso Zokuhlela Komkhaya . 1992; 24: 269-273. Kufinyelelwe ngokubhalisa kwangasese.
I-PFA Van Bheka no-H. von Hertzen. "Ukwelashwa Okuphuthumayo." I-Bulletin Yezokwelapha yaseBrithani 1993; 49: 158-170. Kufinyelelwe ngokubhalisa kwangasese.
UP. Murray. [Septemba 9, 2005]. "UClinton, Murray kanye noSenators 11 bacela i-GAO ukuthi ikhululwe ukuhlolwa kohlelo lokuvunywa kwe-Plan B." Kufinyelele ngo-10/11/12.
RL Mackenzie. [Septemba 2, 1998]. "I-Kit Yokuvimbela Okuphuthumayo Yesivinini Esiphuthumayo - Umkhiqizo Wokuqala Wokukhulelwa Wokuqala Nokuphela - Kuvunyelwe yi-FDA." Kufinyelelwe ngo-10/11/12.
I-Tummino v. Hamburg (No. 12-CV-763) Icala: 13-1690 (INkantolo Yokwedlulisa Amacala E-United States Yesibili Yesibili June 5 2013). Kufinyelelwe ngo 6/6/13.
I-Tummino v. Hamburg , No. 12-CV-763 (ERK) (VVP) (EDNY Apr. 4, 2013). Ifinyelele ngo-10/11/3.
Tummino v. Torti , 603 F. Ukunikezela. 2d 519 (EDNY, Mar. 23, 2009). Ifinyelele ngo-10/11/3.