Ukuhlunga ngeCandelo loKhuseleko oluPhezulu
Cwangciso B I-One Step-step yafumana imvume ye-FDA ngomhla we-13 kuJulayi 2009, ithatha indawo yepilisi emibini yePlani B. Le nkqubo yokukhulelwa ngokukhawuleza iqulethe eyodwa yomlomo (i- levonorgestrel tablet, 1.5 mg).
NgoJulayi 2012, i-FDA ivume i- Next Choice One Dose , ngoFebruwari 2013, i-FDA ivume iNdlela yam , kwaye ngoFebruwari 2014, i-FDA ivunywe ukuthatha i-Action Action - zonke ezintathu zineendlela eziphambili zokupasa i-Plan B.
Kukho enye indlela ebizwa ngokuba yi- AfterPill, kodwa oku kungathengwa kuphela kwi-intanethi.
Ukususela ngo-2006, abafazi kunye nabashumi abaneminyaka eli-18 nangaphezulu baye bavunyelwa ukuthenga iPlani B phezu kwe-counter-counter-counter kwi-pharmacy zendawo (kwaye abo bangaphantsi kwe-18 babedinga isigqirha kugqirha wabo). Isicwangciso B (kunye nokutshintshwa kwayo, iSicwangciso B Isinyathelo esinye Isenziweyo) senziwa yiTeva Pharmaceuticals.
Ngoku, nabani na (nawuphi na unyaka) banokuthenga i-Plan B inye-nyathelo okanye enye yeenguqu zayo ezintathu, ukuthatha isenzo, indlela yam okanye i-Next Choice enye i-Dose, ngaphaya kwe-counter, ngaphandle kwemvume. Inkqubo yokwamkelwa ekhokelela ekufumanekeni kweCwangciso B inye-nyathelo, ngaphaya kwe-counter no-restriction age has been in controversy and confusion - kushiya abantu abaninzi bedidekile malunga nale meko yangoku yokukhusela kunye neenkqubo zokuvunywa ezikhokelela ukuba sihlala phi namhlanje.
Lapho Ukudideka Kwaqala khona:
Abantu abaninzi baye bakhohliswa malunga nabani abanokuyithengisa iCwangciso B enye inyathelo.
Ukudideka kwasekuqaleni kuvela kwi-FDA isimemezelo ngo-Apreli 2009 esithi i-FDA iya kuvumela umenzi wePlani B ukwenza iSicwangciso B sifumaneke kubasetyhini abangama-17 nangaphezulu ngaphandle kwemithi. Isitatimende se-FDA sikhokelela abaninzi ukuba bakholelwe ukuba abaneminyaka eli-17 ubudala banokungathengisa iPlani B ngaphezulu. Uninzi lwabantu aluzange luqaphele ukuba oku kwakungenjalo kwangoko i-FDA yabhengeza, ngo-Juni 24, 2009, ukuba i-arhente ivume i- Next Choice , i-prescription-kuphela kuphela yesiqhelo sesicwangciso seNkqubo yezoPhulo oluphuthumayo B, kubabhinqa abaneminyaka eli-17 nangaphezulu.
Ukudideka kwavela ngokusekelwe kwinqanaba elilandelayo ukususela ngoJuni 2009:
"Ngo-2006, isiCwangciso B sagunyazisiwe ukuba singabonakali kokusetyenziswa kwabasetyhini abaneminyaka eli-18 nangaphezulu. Isicwangciso B sasihlala sitholakalayo njengemveliso yonyango kuphela yabasetyhini abaneminyaka eli-17 nangaphantsi. naphantsi. "
Olu phetshana lwe-FDA lukhokelela abaninzi ukuba bazibuze-ukuba ngaba i-FDA sele ivume abantu ngabangaphezulu kweminyaka eyi-16 ukuthenga i-Plan B ngaphaya kwe-counter-counter, ngoko kutheni i-FDA ibhengeza ukuba kude kube ngoku, i-OTC Plan B isetyenziselwe abo ubuncinane ubuneminyaka engama-18 ubudala?
U-Siobhan DeLancey, obhala i-FDA yokukhululwa kweendaba evakalisa ukuvunyelwa kwesiCwangciso B, iphendule lo mbuzo ngokuthi, "kungakhathaliseki ukuba i-FDA yathi ku-Epreli odlulileyo, uneminyaka eyi-17 akanakho ukufikelela kwi-counter-counter-counter Cwangcisa B ".
Umbuzo wahlala, ukuba ngaba kunjalo, ngaba kunjalo, kutheni i-FDA yamemezela imvume yayo yokuba abaneminyaka eyi-17 banokuthenga i-Plan B?
Inkcazo:
Kubonakala ukuba ininzi yokudideka ibangelwe ukuchazwa ngokucacileyo ngo-Apreli 22, 2009, isaziso se-FDA esicacisayo sokuthi abasetyhini abaneminyaka eli-17 nangaphezulu banokungathenga i-Plan B ngaphezulu kwe-counter. Esi sigqibo se-FDA sisisiphumo somyalelo wenkundla yasemthethweni esiyalela i-FDA ukuba ivumele abaneminyaka eyi-17 ukuba bathenge iSicwangciso B.
Umgwebi uKorman wabuza kwakhona i-agqwetha ukuba acinge ukuba iipilisi kufuneka zifumaneke ngaphaya kwe-counter-counter to women of all ages. Isigwebo senkundla sifikelele ukuba isinqumo sokuqala sokuthintela ukufikelela kwi-FDA sisekelwe kwizopolitiko kwaye kungekhona isayensi.
Kwisibhengezo sesebe, i-FDA ichaza,
"Ngokuhambelana nomyalelo wenkundla, kwaye ngokuhambelana neziphumo zenzululwazi ukususela ngo-2005 yiZiko loVavanyo loPhando kunye noPhando, i-FDA ithumele ileta kumenzi weCwangciso B ukuba inkampani inokuthi, ngokungeniswa nokuvunyelwa kwesicelo esifanelekileyo, ISicwangciso seB b ngaphandle kwemvume kubasetyhini abaneminyaka eli-17 ubudala nangaphezulu. "
Ekholelwa ukuba ezi ndaba zithetha ukuba abaneminyaka eli-17 ubudala banokungathengisa iPlani B phezu kwe-counter-counter, abavakalisi bempilo yokuzala abanomdla. UCecile Richards, umongameli we-Planned Parenthood Federation yaseMelika, wade wathi imvume ye-FDA "ingqina eliqinileyo kwabasetyhini baseMerika ukuba impilo yabo ifike phambi kwezopolitiko. kunceda ukunciphisa inani lokukhulelwa okungalindelekanga kunye nokukhusela impilo kunye nokhuseleko lwabafazi bonke. "
Sekunjalo, ngelo xesha, iSicwangciso B sasisasetyenziswa kuphela kubantu abangaphezu kweminyaka eyi-17 . Yonke into eyenziwa yi-FDA ngesigqibo sayo kukuba i-agency ngoku iya kuvumela umenzi wePlani B ukuba athumele isicelo sesimo sokuthengisa kwi-Plan B ukuya kweli qela leminyaka. Xa ebuzwa malunga nesimo solu sicelo, uDeLancey (okhulumela i-FDA) akayi kuthetha ukuba ingafaki isicelo singenisiwe, kodwa siza kugqabaza nje ukuba akukho sicelo se-OTC esithengisa kwiminyaka eli-17 ubudala .
Imbali echazwe kwezopolitiko:
Konke oku kudideka malunga nabani abanokuthenga isiCwangciso B esinye Isinyathelo sifana nesimbolo sokulwa okude kunye nezopolitiko malunga nokuthengiswa kwe-OTC yeSicwangciso B. Ababukeli bezempilo ababeletha baphinde bafumane ithemba kwi-post-counter-counter-post emva kweNkundla yeSithili sase-US. ISithili saseMpuma saseNew York sigwebile, ngo-Matshi 23, 2009, ukuva , ukuba i-FDA imele iqwalasele kwakhona isigqibo sayo phantsi kolawulo lwe-Bush ukukhawulela ukufikelela kwimeko yokukhulelwa kwangxamisekileyo. UMgwebi wesithili sase-US u-Edward Korman waphinde wathi i-FDA yavumela iipolitiki ukuba iphazamise isinqumo sayo esifanelekileyo.
Ngo-2006, amagosa e-FDA avunyelwe ukuba kube lula, emva kokuthengiswa kwe-Plan B - ukuvumela abo bantu abaneminyaka eli-18 nangaphezulu ukuba bathenge i-Plan B emva kokubonisa ubungqina beminyaka ngelixa besidinga imithi yabasetyhini abaneminyaka eli-17 ubudala. Nangona kunjalo, kumgwebo wephepha le-52, uMgwebi uKorman wayala i-FDA ukuba ivumele abantu abaneminyaka eyi-17 ukuba bathenge iPlani B ngaphandle kwemvume phantsi kweemeko ezifanayo ukuba isiCwangciso B sasifumaneka kwabasetyhini abangaphezu kweminyaka eyi-18 besithi, "I-FDA iphindaphinda kwaye ulibazise ngokungenangqiqo ukukhupha isigqibo kwiCwangciso B malunga nezizathu zesohlwayo. "
INkundla iyaqhubeka yathi i-FDA ichithekile kwiinkqubo zayo eziqhelekileyo zokuhlaziya iimveliso ze-OTC kwaye i-arhente yenze kuphela isinqumo seSicwangciso B (ngo-2006) ngenxa yeongongelo zokubamba iSecate confirmation kaDkt. Andrew von Eschenbach ukuba abe ngumkhomishina we-FDA. Enyanisweni, isigqibo sika-2006 sagqithwe ngaphezu kweminyaka emithathu njengoko ulawulo lwe-Bush luchasene nokuvunyelwa kwe-FDA yeSicwangciso B, ekhankanya "ukukhathazeka kwezokhuseleko," nangona iiphaneli zengcebiso ze-FDA zicebisa ukuba akufuneki kubekho ubuncinci beemali ekuthengeni iCwangciso B. Ngaloo ndlela, ijaji yalela i-arhente ukuba ihlolisise ukuba ingaba yintoni eyenza ukukhulelwa ngokukhawuleza kokufumaneka ngaphandle kwemimiselo yokudala. I-FDA iphendule ukuba ihlaziya isigqibo sejaji. UKorman waphinda wagweba ukuba umyalelo wakhe kufuneka uthotyelwe kwiintsuku ezingama-30. Oku kukhokelela kwingxelo "yehlazo" ka-Ephreli ka-2009 ka-FDA eyabangela konke ukudideka malunga nabani na abanokuyithengisa iCwangciso B.
Apho sihlala namhlanje:
Nangona ingxaki yokukhulelwa ngokukhawuleza ayiyinto entsha kwiingqungquthela zoluntu, kusasaza iingxabano ezininzi - njengokuba zenzayo xa zaziswe kuqala eMelika. Ukuphikisana kubangelwa yienkolelo zabantu malunga nokuba ingaCwangcanga B Isinye Isinyathelo (okanye iipilisi emva kwenyanga) siphelisa ukukhulelwa.
Ukukhulelwa ngokukhawuleza okuqhubekayo kuyinkxalabo enemvakalelo kunye nengxabano, bobabini abameli abakholelwa kwiCwangciso B Elinye inyathelo liya kunciphisa inani lokukhulelwa okungavumelekanga kunye nokukhupha isisu kunye nabachasayo abakholelwa ukuba ukusebenzisa iSicwangciso B Isinyathelo esinye Isinyathelo sifana nokukhupha isisu . Ukuphikisana kubangela ukuba le ngxoxo ikhulume ngeendlela zokukhulelwa ngokukhawuleza. Le mpikiswano inomsindo kangangokuthi iyakwazi ukufakela izigqibo ze-FDA malunga neSicwangciso B, ukushiya i-arhente ukuba ityholwe ngokuvumela iipolitiki ukuba zilawule izigqibo zazo kunokuba isayensi.
Ngelishwa, inkolelo engafaneleko yokukhulelwa kwangxamisekileyo kwakha ukukhupha isisu kufikelelo kunye nokusetyenziswa kweCwangciso B Elinye Isinyathelo njengoko abantu abaninzi beqhubeka bedibanisa iipilisi emva kwenyanga kunye nepilisi yokukhupha isisu (RU486 ). Nangona ipilisi yokukhupha isiphumo ekupheliseni ukukhulelwa kwaye isetyenziselwa kuphela emva kokukhulelwa (kwaye akukho ngaphaya kweentsuku ezingama-49 ukususela kwimizuzu yokugqibela yesibini). Isicwangciso B Isinyathelo esinye Isisetyenzisiwe sisetyenziselwa ukuthintela ukukhulelwa xa kuthathwa iintsuku ezi-3 ukuya kwezi-5 emva kwesondo esingakhuselekanga. Ngeke kulimaze ukukhulelwa okukhoyo.
Enyanisweni, iingcali zonyango zicinga ukuba ukukhulelwa kuya kusekwa emva kokufakwa kweqanda ekhulile. Abaphulaphuli bokukhulelwa ngokukhawuleza bahlala bomelele ngokuzisa abantu abacwangcise isiCwangciso esinye isinyathelo esingesona isithunywa sokukhupha isisu. Abaphathi bezokwelapha bachaza ukukhupha isisu njengokuphazamiseka kweqanda elichumisiweyo. Oku kuthetha ukuba akunakwenzeka kwiCwangciso B Elinye Isinyathelo sokuphelisa ukukhulelwa kuba, ngokukhawuleza, ukukhulelwa akukho. Umgaqo-nkqubo we-Federal, ngokuhambelana neengcali zonyango, ichaza imithi, iziyobisi kunye nezixhobo ezenza ngaphambi kokumiselwa njengeziqulunqo zokukhulelwa kwaye azikho izithunywa eziphelisa ukukhulelwa.
Isicwangciso B Isinyathelo esinye Isinyathelo esiphephile kwaye sisebenza ngokufanelekileyo kubasetyhini ukukhusela ukukhulelwa kwangaphambili emva kokubandakanyeka kwintlobano yesondo engakhuselekanga okanye ulwaphulo lokulawula ukuzalwa kwaye kuboniswe ukuba lunyulo olunamandla oluye lunceda kakhulu ukunciphisa inani okanye ukukhulelwa okungafunekiyo kunye njengenani lokukhupha izithatho eziza kwenzeka xa ukukhulelwa kungakhutshwanga ngokusebenzisa ukukhulelwa kwangokukhawuleza.
Ngoko, Ngubani Ongathenga Isicwangciso B Isinyathelo Esinye?
Ukususela ngoJuni 20, 2013, i-FDA yamkele isicelo seTeva esongezelelweyo kunye nesicwangciso esivunyiweyo seB B Isinyathelo esinye Isingeniso sokubhaliweyo / isimo se-counter-counter-counter-counter. Oku kuthetha ukuba abafazi beeminyaka yonke banokuthenga iSicwangciso B Isinyathelo esinye, esimele sibe ngokucwangciswa kwintsapho / kwinqanaba lokuthengisa izidumbu.
NgoFebruwari 25, 2014, i-FDA yabhengeza ukuba iSicwangciso seSicwangciso seNqanaba -B esinye seNyathelo (enye indlela kunye noKhetho olulandelayo) luya kufumaneka ngaphandle kwemvume okanye nayiphi na imithintelo yeminyaka-nangona i-arhente idinga ukuba le mveliso ifake iileyibhile ezisebenzisayo zijoliswe kubasetyhini abaneminyaka eli-17 nangaphezulu. Thatha iNtsebenzo ibuye ifumaneke i-OTC nayiphi na iminyaka, kodwa ngenxa yokuba yenziwe yiTeva, ayikho
- Iphi na indlela yokuthenga Isicwangciso B Isinyathelo esinye Isicwangciso kunye nesiCwangciso samaGrike B Isinyathelo esinye?
- Indlela yokusebenzisa iPlani B Isinyathelo esinye, I-Next Choice One Dose, kunye neNdlela yam?
Ngoko ... ukuba udinga ukuthenga ukukhulelwa kwangoku, ukufikelela kungoku:
- Isicwangciso B Isinyathelo esinye- sinokuthengwa i-OTC (ngaphandle kwemithi) kulabo baneminyaka.
- Indlela Yanga , Thatha Isenzo kunye noKhetho olulandelayo I-One Dose (Cwangcisa iB B imveliso ethile yezinto eziqhelekileyo) - inokuthengwa i-OTC, (ngaphandle kwemvume) kulawo nawuphi na ubudala.
- Cwangcisa uB generic Next Choice (iipilisi ezimbini zokukhulelwa ngokukhawuleza) - zikhoyo emva kwe-countermist counter, ngaphandle kwemvume, kubantu abaneminyaka eli-17 nangaphezulu. Kudingeka imfuno yesigqibo kulabo abangaphantsi kwe-17.
Imithombo:
FDA Drug Data. [10-03-2013] "I-Orange Book: Iimveliso ezichithwayo zeDrug kunye neZingqinisiso zokuLingana kweeNyango."
FDA Newsroom. [04-22-2009] "Ukuhlaziywa kwe-FDA Action kwiCwangciso B (levonorgestrel) Iibhilethi." Fi kelele 10/6/13.
FDA Newsroom. [06-24-2009] "I-FDA iyavuma i-Generic Prescription-kuphela nguSicwangciso seNkqubo B yoNyango oluKhuselekileyo kwiMinyaka yobuGqirha 17 nangaphantsi." Fi kelele 10/6/13.
I-Tummino v. Torti , 603 F. Ukuncedisa. 2d 519 (EDNY, Mar. 23, 2009). Fi kelele 10/6/13.