Ukuhlunga Nge-Emergency Contraception Maze
Hlela iB B-One-Step yamukelwa i-FDA ngomhla ka-13 kuNtulikazi 2009, esikhundleni sePilisi yePilisi emibili. Lokhu kokukhulelwa okuphuthumayo kunomuthi owodwa nje womlomo (i- levonorgestrel tablet, 1.5 mg).
Ngo-Julayi 2012, i-FDA ivume i- Next Choice One Dose , ngo-Febhuwari 2013, i-FDA ivume iNdlela Yami , futhi ngoFebruwari 2014, i-FDA evunyelwe ukuthatha isinyathelo - zonke ezintathu zindlela zokudala zamaphilisi ezilodwa zokuhlela i-One-Step.
Kukhona futhi enye indlela ejwayelekile ebizwa ngokuthi i- AfterPill, kodwa lokhu kungathengwa kuphela ku-intanethi.
Kusukela ngo-2006, abesifazane nabesilisa abaneminyaka engama-18 nangaphezulu baye bavunyelwa ukuthenga i-Plan B phezu kwe-counter kumakhompiya asekhaya (nalabo abangaphansi kweminyaka engu-18 badinga umshwalense kusuka kudokotela wabo). Hlela B (kanye nokushintshwa kwayo, iSicwangciso B Isinyathelo Esinye) sakhiwa yi-Teva Pharmaceuticals.
Manje, noma ubani (nganoma yisiphi ubudala) angathenga i-Plan B Isinyathelo esisodwa noma enye yezinguqulo zayo ezintathu, ukuthatha isenzo, indlela yami noma okukhethwa kukho okulandelayo, ngaphandle kwe-odokotela. Inqubo yokuvunywa eholela ekutholakaleni kwePlani B-Isinyathelo esisodwa, ngaphezulu kwe-counter ngaphandle kwemingcele yobudala iningi elibhekene nokuphikisana nokudideka - okushiya abantu abaningi besalokhu bedidekile ngesimo samanje sokukhulelwa kwezimo eziphuthumayo kanye nenqubo yokugunyaza eholayo nathi lapho sikhona namuhla.
Lapho Ukudideka Kwaqala khona:
Abantu abaningi baye bakhohliswa ngokuthi ubani ongathenga ngempela uhlelo lwe-B B One Step.
Ukudideka kwasekuqaleni kubangelwa isimemezelo se-FDA ngo-Ephreli 2009 sithi i-FDA izovumela umenzi we-Plan B ukuba enze uhlelo B olutholakala kwabesifazane abaneminyaka engu-17 nangaphezulu ngaphandle kwemithi. Lesi sitatimende se-FDA sikhombisa abaningi ukuthi bakholelwa ukuthi abaneminyaka engu-17 bangakwazi ukuthenga i-Plan B ngaphezulu. Abantu abaningi abazange babone ukuthi lokhu akulona icala kuze kube yilapho i-FDA yamemezela, ngoJuni 24, 2009, ukuthi le nhlangano ivume ukulandela okulandelayo , inguqulo yokukhiqiza okuphuthumayo ye-Plan B, yabesifazane abaneminyaka engu-17 nangaphezulu.
Lokhu kudideka kwavela ngokususelwa kulokho okulandelayo okushiwo ukukhululwa kwezindaba ngoJuni 2009:
"Ngo-2006, i-Plan B yavunywa ukuthi ukusetshenziswa kwabesifazane abaneminyaka engama-18 nangaphezulu kungasetshenzisiwe. Ukuhlela B kwahlala kuyatholakala njengomkhiqizo owodwa kuphela wezinsikazi kwabesifazane abaneminyaka engama-17 nangaphansi. Ukuvunyelwa kwanamuhla kuvumela ukuthengiswa komkhiqizo owenziwe ngomuthi kuphela kubantu besifazane abaneminyaka engu-17 futhi ngaphansi. "
Lokhu kukhululwa kwe-FDA kuholela abaningi ukuba bazibuze-uma i-FDA isivumile kakade abantu abaneminyaka engaphezu kwengu-16 ukuthenga i-Plan B ngaphezulu kwe-counter, ngakho kungani i-FDA imemezela ukuthi kuze kube manje, ukusetshenziswa kwe-OTC Plan B kwakunqunyelwe kulabo okungenani uneminyaka engu-18 ubudala?
U-Siobhan DeLancey, owabhala inkulumo ye-FDA yokumemezela ukwamukelwa kwe-Generic Plan B, waphendula lo mbuzo ngokumane athi, "kungakhathaliseki ukuthi i-FDA ithi kuphelile ngo-Ephreli, oneminyaka engu-17 ubudala akanalo ukufinyelela okungekho ngaphezulu Hlela B ".
Umbuzo wabe esehlala, uma ngabe kunjalo, kunjalo, kungani i-FDA yamemezela ukuthi imvume yayo yokuthi abaneminyaka engu-17 bangathenga i-Plan B?
Incazelo:
Kubonakala sengathi ukudideka okuningi kubangelwa ukuchazwa ngokucacile isimemezelo se-FDA sika-Ephreli 22, 2009, okusolakala ukuthi simemezela ukuthi abesifazane abaneminyaka engu-17 ubudala noma ngaphezulu bangakwazi ukuthenga i-Plan B ngaphezulu kwe-counter. Lesi sinqumo se-FDA sasiwumphumela wenkantolo yenkantolo eyala i-FDA ukuthi ivumele izingane ezineminyaka engu-17 ukuthi zithenge iPulani B.
UJaji Korman wabuye wacela le nhlangano ukuba ihlole ukuthi ngabe iphilisi kufanele itholakale ngaphezu kwe-counter kubesifazane besonke ubudala. Isinqumo senkantolo sitholile ukuthi isinqumo sokuqala sokuthi ukuvimbela ukufinyelela kwe-FDA sisekelwe ezombusazwe hhayi ngesayensi.
Esimemezelweni se-agency, isitatimende se-FDA siyachaza,
"Ngokuhambisana nesinqumo senkantolo, futhi ngokuhambisana nezibalo zesayensi kusukela ngo-2005 yiSikhungo sokuHlola nokuHlola kweDrug, i-FDA ithumele incwadi kumkhiqizi wePlani B ukuthi inkampani ingakwazi, ngokuthumela nokuvunyelwa kwesicelo esifanele, I-Market Plan B ngaphandle kwemithi kwabesifazane abaneminyaka engu-17 ubudala nangaphezulu. "
Ekholelwa ukuthi lezi zindaba zisho ukuthi oneminyaka engu-17 ubudala manje bangakwazi ukuthenga i-Plan B ngaphezulu kwe-counter, abameli bezempilo bokuzala bajabule. UCecile Richards, umongameli we-Planned Parenthood Federation of America, wathi ngisho nokuvuma kuka-FDA ukuthi "yisitatimende esinamandla kwabesifazane baseMelika ukuthi impilo yabo ifika ngaphambi kwezombangazwe." Yile ndlela okufanele ibe ngayo. ukusiza ukunciphisa inani lokukhulelwa okungalindelekile nokuvikela impilo nokuphepha kwabesifazane bonke. "
Noma kunjalo, ngaleso sikhathi, i-Plan B yayisatholakala kuphela kulabo abangaphezu kweminyaka engu-17. I-Catch? Konke okwakushiwo yi-FDA ngesimemezelo sayo ukuthi i-agency manje izokuvumela umkhiqizi wePlank B ukuba athumele isicelo sesimo sokuthengisa ngaphezulu kwe-counter ye-Plan B kuleli qembu lobudala. Lapho ebuzwa ngesimo salolu hlelo lokusebenza, uDeLancey (okhulumela i-FDA) ngeke athi uma lolu hlelo lokusebenza luhanjisiwe noma cha, kodwa luzobeka kuphela ukuthi akukho sicelo sokuthengisa kwe-OTC eneminyaka engu-17 esivunyelwe .
Umlando okhokhelwayo kwezombangazwe:
Konke lokhu kudideka mayelana nokuthi ngubani ongathenga i-Plan B-Isinyathelo esisodwa nje isifaniso sokulwa okude nezopolitiki mayelana nokuthengiswa kwe-OTC ye-Plan B. Abaphikisi bezempilo ababeletha baphinde bathole ithemba ngesimo esingaphezu kwe-counter emva kweNkantolo yesiFunda yase-US ISifunda saseMpumalanga saseNew York sabusa, ngo-Mashi 23, 2009, ukuzwa ukuthi i-FDA kumele ibuye iphinde icabangisise ngesinqumo sayo ngaphansi kwe-Bush Administration ukukhawulela ukufinyelela kokukhulelwa okuphuthumayo. Ijaji lesifunda sase-US u-Edward Korman laqhubeka lathi i-FDA ivumela izombusazwe ukuba ziphazamise ukuzenzela kwayo okuvamile.
Ngo-2006, izikhulu ze-FDA zavumela ukuba kube lula, ngemuva kokuthengiswa kwe-Plan B - ukuvumela labo abaneminyaka engu-18 nangaphezulu ukuthi bathenge i-Plan B ngemuva kokubonisa ubufakazi beminyaka yobudala ngenkathi befuna udokotela wesifazane oneminyaka engu-17 ubudala nangaphansi. Kodwa-ke, esinqumweni sekhasi le-52, uJaji Korman wayala i-FDA ukuthi ivumele izingane ezineminyaka engu-17 ukuthi zithenge i-Plan B ngaphandle kwemithi ngaphansi kwezimo ezifanayo ukuthi i-Plan B yayitholakala kwabesifazane abangaphezu kweminyaka engu-18 ethi, "I-FDA iphindaphindiwe futhi wephuza ngokungenangqondo ukukhipha isinqumo ku-Plan B yezizathu ezingasolwa. "
Inkantolo yaqhubeka yathi i-FDA yahlukana nezinqubo zayo ezijwayelekile zokubukeza imikhiqizo ye-OTC nokuthi i-ejensi yenze isinqumo sePlani B (ngo-2006) ngenxa yokwesatshiswa kokubamba isiqiniseko seSenate u-Andrew von Eschenbach sokuba abekhomishana we-FDA. Eqinisweni, isinqumo sika-2006 sakhishwe eminyakeni engaphezu kwemithathu njengoba ukuphathwa kukaBush kuphikisa ukuvunywa kwe-FDA kwePlani B, echaza "ukukhathazeka kokuphepha," nakuba ama-panel advisor e-FDA ancoma ukuthi akufanele kube nemingcele yobudala kulabo abangathenga i-Plan B. Ngakho-ke, ijaji layala le nhlangano ukuba ibuke ukuthi ngabe yenzani ukwelashwa okuphuthumayo kuyatholakala ngaphandle kwemingcele yobudala. I-FDA iphendule ukuthi ibuyekeza isinqumo sejaji. UKorman waphinde wathi isigwebo sakhe kufanele sihambisane nezinsuku ezingama-30. Lokhu kuholela "esimemezelo" se-Apreli 2009 FDA esitatimendeni esabangela konke ukudideka ngokuthi ngubani ongathenga i-Plan B.
Lapho Sihlala Namuhla:
Yize umqondo wokukhulelwa okuphuthumayo awulona umbono omusha emphakathini, usaqhubeka nokuphikisana izingxabano eziningi - njengoba nje kwenzeka lapho kuqala okokuqala e-United States. Ukungqubuzana kubangelwa yizinkolelo zabantu ngokuthi ngabe i-Plan B One Step (noma i-pillow-morning after) iqeda ukukhulelwa noma cha.
Ukwelashwa kokuphuthumayo okuqhubekayo kuyaqhubeka kube yinkinga enomzwelo neyinkinga, kokubili abameli abakholelwa ukuthi uhlelo lweSupport B-One-Step luzokwehlisa inani lokukhulelwa okungahlosiwe nokukhipha isisu kanye nabaphikisi abakholelwa ukuthi ukusebenzisa i-Plan B Isinyathelo esisodwa kufana nesisu sokukhipha isisu . Ukungqubuzana okubangela le mpikiswano ibeka izindlela zokuvimbela ukukhulelwa okuphuthumayo. Le mpikiswano ivutha kakhulu kangangokuthi ikwazi ngisho nokufakela izinqumo ze-FDA mayelana nePlani B, ishiya i-ejensi ukuba iphikiswe ngokuvumela izombangazwe ukuba ziqondise izinqumo zabo kunokuba isayensi.
Ngeshwa, inkolelo engalungile yokuthi ukukhulelwa kwezimo eziphuthumayo kubangela ukukhipha isisu kuye kwaba nomgoqo ekufinyeleleni nasekusetshenzisweni kwePlani B Isinyathelo Esinye njengoba abantu abaningi beqhubeka nokudidliza iphilisi elandelayo ekuseni kanye nephilisi yokukhipha isisu (RU486 ). Nakuba iphilisi lokukhipha isisu liholela ekuqedeni ukukhulelwa futhi lisetshenziselwa kuphela emva kokukhulelwa kusungulwa (futhi kungabi ngaphezu kwezinsuku ezingu-49 kusukela esikhathini sokugcina sokuhamba komfazi), Isu B Isinyathelo esisodwa sisetshenziselwa ukuvimbela ukukhulelwa uma kuthathwa ezinsukwini ezintathu kuya kwezingu-5 emva kocansi olungalondekile. Ngeke kulimaze ukukhulelwa okukhona.
Eqinisweni, ochwepheshe bezokwelapha bacabanga ukuthi ukukhulelwa kuyasungulwa emva kokufakelwa kweqanda elikhulile. Abagqugquzeli bokukhulelwa kwezimo eziphuthumayo bahlala beqinile ngokukwazisa abantu ukuthi uhlelo lwe-One-Step aluyona i-agent yokukhipha isisu. Iziphathimandla zezokwelapha zichaza ukukhipha isisu njengokuphazanyiswa kweqanda elifakwe umquba. Lokhu kusho ukuthi akunakwenzeka ku-Plan B Enye-Isinyathelo ukuqeda ukukhulelwa kusukela, ngokwemithi, ukukhulelwa akukhona. Inqubomgomo ye-Federal, ngokuhambisana nabachwepheshe bezokwelapha, ichaza imithi, izidakamizwa namadivayisi asebenza ngaphambi kokufakelwa kabusha njengamalungiselelo okukhulelwa hhayi ama-agent aphelisa ukukhulelwa.
Hlela B I-One Step isindlela ephephile futhi ephumelelayo yabesifazane ukuvimbela ukukhulelwa okungenzeka ngemuva kokuhlanganyela ekungeneni kobulili okungavimbelwe noma ukuhluleka kokulawula kokuzalwa futhi kuboniswe ukuthi kube nenketho enkulu kakhulu eye yasize kakhulu ukunciphisa inombolo noma ukukhulelwa okungadingeki kanye njengoba inani lokukhipha isisu elizokwenzeka uma lezi zikhukhula zingavinjelwe ngokusebenzisa ukusetshenziswa kwezimo eziphuthumayo zokubeletha.
Ngakho-ke, ubani ongathenga isiteji B isinyathelo esisodwa?
Kusukela ngo-June 20, 2013, i-FDA yamukele isicelo seTeva esongezelayo nesiphakamiso sePulani B Isinyathelo esisodwa sokungabhaliseki / isimo esiphezulu. Lokhu kusho ukuthi abesifazane besonke ubudala bangathenga i-Plan B Isinyathelo esisodwa, okumele kube manje ekuhleleni komndeni / kwesigaba samasitolo okuthengisa emakhaya.
Ngo-Ephreli 25, 2014, i-FDA yamemezela ukuthi izindlela ze-Plan B eyodwa-Step generic alternatives (I-My Way ne-Next Choice One Dose) manje zizotholakala ngaphandle kwemithi noma yimiphi imikhawulo yobudala - nakuba i-ejensi idinga ukuthi le mikhiqizo ibandakanye Amalebula abo asetshenziselwa ukuthi abesifazane baneminyaka engu-17 nangaphezulu. Thatha isinyathelo futhi sitholakalayo i-OTC nganoma yisiphi ubudala, kodwa ngoba sakhiwa yi-Teva, ayikho
- Uphi futhi Ungawuthengisa Kanjani Isakhiwo B Isinyathelo Esinye Isinyathelo no-Generic Plan B Isinyathelo Esinye?
- Indlela yokusebenzisa i-Plan B isinyathelo esisodwa, ukhetho olulodwa olulandelayo, nendlela yami?
Ngakho ... uma udinga ukuthenga ukukhulelwa kokuphuthumayo, ukufinyeleleka kanje:
- Hlela B Isinyathelo Esinye - singathengwa i-OTC (ngaphandle kwemithi) kulabo abanoma yimuphi ubudala.
- Indlela Yami , Thatha Isinyathelo Nokukhethwa Okulandelayo I-One Dose (Cwangcisa B imikhiqizo ejwayelekile yezinyathelo ezijwayelekile) - ingathengwa i-OTC, (ngaphandle kwemithi) kulabo abanoma yimuphi ubudala.
- Hlela uB gener generic Okukhethwa Okulandelayo (okutholakala kokubeletha okuphuthumayo kokubili kwamapilisi) - etholakalayo ngemuva kwekhasi lekhemisi, ngaphandle kwemithi, kulabo abaneminyaka engu-17 nangaphezulu. Kudingeka isiguli kulabo abangaphansi kweminyaka engu-17.
Imithombo:
I-FDA Databases Database. [10-03-2013] "I-Orange Book: Imikhiqizo Yezidakamizwa Evunyelwe ngeZingqinamba Zokulingana Nezokwelapha."
I-FDA Newsroom. [04-22-2009] "Ukuvuselelwa kwe-FDA Action ku-Plan B (levonorgestrel) Amathebulethi." Ifinyelele ngo-10 / 6/13.
I-FDA Newsroom. [06-24-2009] "I-FDA ivumela i-Generic Prescription-kuphela engu-Plan B Yokukhulelwa Ngokuphuthumayo Kweminyaka Yabafazi 17 nangaphansi." Ifinyelele ngo-10 / 6/13.
Tummino v. Torti , 603 F. Ukunikezela. 2d 519 (EDNY, Mar. 23, 2009). Ifinyelele ngo-10 / 6/13.