Kusankha Kupyolera Mukumangika Kwadzidzidzi Maze
Konzani B Bwalo limodzi lovomerezeka la FDA pa July 13, 2009, m'malo mwa mapiritsi awiri a mapulani a B. Kulera kosavuta kumakhala ndi piritsi imodzi yokha ( levonorgestrel piritsi, 1.5 mg).
Mu July 2012, FDA inavomereza Pulogalamu Yotsatira ya Chotsatira , February 2013, a FDA adavomereza Njira Yanga , ndipo mu February 2014, FDA inavomerezedwa kutenga Action - zonse zitatuzi ndi njira zowonjezera zapiritsi imodzi yokonzekera B Yoyamba.
Palinso njira ina yowonjezera yotchedwa AfterPill, koma izi zimangogulidwa pa intaneti.
Kuchokera mu 2006, amayi ndi abambo azaka khumi ndi zisanu ndi zisanu ndi zisanu ndi chimodzi adaloledwa kugula Mapulani a B B -pharmacies (ndipo omwe ali ndi zaka 18 amafunikira mankhwala kuchokera kwa dokotala). Sungani B (kuphatikizapo m'malo mwake, Pulani Yoyamba B) imapangidwa ndi Teva Pharmaceuticals.
Tsopano, aliyense (wa msinkhu uliwonse) angagule Mapulani A B Mmodzi Wachitatu kapena chimodzi mwamasulidwe ake atatu, Chitani, Njira Yanga kapena Chotsatira Chokha Mmodzi, pa-counter, popanda mankhwala. Njira yovomerezeka yomwe ikutsogolera kukhazikitsidwa kwa ndondomeko B yotsimikiziranso zaka zapakati pazomwe zilibe zaka zakubadwa zakhala zikukangana ndi kusokonezeka - kusiya anthu ambiri akusokonezeka chifukwa cha vutoli lachidziwitso komanso njira yobvomerezeka yomwe ikutsogolera ife komwe ife tiri lero.
Kumene Chisokonezo Chinayambira:
Anthu ambiri asochera kuti ndani angagule Plan B Yoyamba.
Chisokonezo pachiyambi chinachokera ku chidziwitso cha FDA mu April 2009 kuti FDA idzalola wopanga Plan Plan B kuti apange Plan B yopezeka kwa amayi a zaka 17 kapena kuposera popanda mankhwala. Mawuwa a FDA amachititsa ambiri kukhulupirira kuti zaka 17 zatha tsopano kugula Mapulani a B B. Anthu ambiri sanazindikire kuti izi sizinali choncho mpaka a FDA adalengeza, pa June 24, 2009, kuti bungwelo linalimbikitsa Next Choice , njira yokhayo yothandizira pulogalamu yachangu B, yomwe ili ndi zaka 17 ndi zazing'ono.
Chisokonezo chinayambira mothandizidwa ndi ndondomeko yotsatirayi kuchokera mu ndondomeko ya ofalitsa ya June 2009:
"Mu 2006, ndondomeko B inavomerezedwa kuti asagwiritsidwe ntchito kwa amayi omwe ali ndi zaka zapakati pa 18 kapena kuposerapo. Mapulani a B adakalipo ngati mankhwala okhaokha omwe ali ndi zaka zapakati pa 17 ndi pansi. ndi pansi. "
Magaziniyi ya FDA imapangitsa anthu ambiri kudabwa - ngati FDA idavomereze anthu a zaka zoposa 16 kuti agule Plan B yotsutsana nawo, nanga n'chifukwa chiyani FDA inalengeza kuti mpaka pano, OTC Plan B imagwiritsidwa ntchito kwa iwo okha osachepera zaka 18?
Siobhan DeLancey, yemwe analemba zofalitsa za FDA zomwe zimalengeza kuti akuvomerezedwa ndi Plan B, adayankha funsoli ponena kuti, "ziribe kanthu zomwe FDA idanena mu April, mwana wazaka 17 alibe Sungani B ".
Funso linatsalira, ngati izi zinalidi zoona, n'chifukwa chiyani a FDA adavomereze kuti akuvomereza kuti ana a zaka 17 angathe kugula Plan B?
Ndemanga:
Zikuwoneka kuti kusokonezeka kwakukuluku kunachitika chifukwa chosamvetsetsa malingaliro a nyuzipepala ya FDA ya April 22, 2009, yomwe idzinenera kuti akazi a zaka khumi ndi zisanu ndi zisanu ndi ziwiri angathe kugula Plan B pamwamba pake. Chigamulochi cha FDA chinali chigamulo cha khoti la federal lomwe limalangiza a FDA kuti alole ana a zaka 17 kugula Mapulani a B.
Woweruza Korman adafunsanso bungwe kuti liwone ngati mapiritsi ayenera kupezeka pa-a-counter kwa akazi a mibadwo yonse. Chigamulo cha khoti chinapeza kuti chisankho cha FDA choyamba choletsera kupeza chinali chochokera pa ndale osati pa sayansi.
Mu chidziwitso cha bungweli, mawu a FDA akufotokoza,
"Mogwirizana ndi lamulo la khoti, komanso mogwirizana ndi zomwe asayansi akupeza kuchokera mu 2005 ndi Center for Drug Evaluation ndi Research, a FDA adatumiza kalata kwa wopanga Plan B kuti kampaniyo, povomereza ndi kuvomereza ntchito yoyenera, Mapulani a Msika B popanda mankhwala kwa akazi a zaka 17 kapena kuposerapo. "
Pokhulupirira kuti nkhaniyi imatanthauza kuti ana a zaka 17 angathe tsopano kugula Plan B yotsutsana nawo, omwe amalimbikitsa chithandizo cha thanzi. Cecile Richards, pulezidenti wa Planned Parenthood Federation of America, adanenanso kuti kuvomereza kwa FDA ndi "mawu olimbikitsa kwa amayi a ku America kuti umoyo wawo umabwera patsogolo pa ndale, ndipo ndi momwe ziyenera kukhalira. Thandizo lichepetse chiwerengero cha mimba yosakonzekeke komanso chiteteze thanzi ndi chitetezo cha amayi onse. "
Komabe, panthawi imeneyo, ndondomeko B idakalipo kwa anthu omwe ali ndi zaka zoposa 17 . Zonse zomwe FDA zimatanthawuza ndi chidziwitso chake chinali chakuti bungwe likanatha tsopano kulola wopanga Plan Plan B kuti apereke chilolezo cha malonda a Pulogalamu B kwa zaka izi. Akafunsidwa za momwe ntchitoyi ikuyendera, DeLancey (woimira FDA) sakanena ngati ntchitoyi yatumizidwa kapena ayi, komabe ingangonena kuti palibe ntchito yothetsera malonda a OTC kwa zaka 17 .
Mbiri Yotsogoleredwa Ndale:
Zosokoneza zonsezi za omwe angagule Mapulani a B B Yoyamba ndi chifaniziro chotsutsana kwambiri ndi ndondomeko ya OTC pa Mapulani a OTC a B B. Otsatira zaumoyo okhudzana ndi uchembere akubwezeretsanso chiyembekezo chokhala ndi chiwerengero chokwanira pambuyo pa Khoti la Chigawo la US ku Chigawo chakummawa cha New York chinagamula, pa March 23, 2009, kumva kuti FDA iyenera kuganiziranso chisankho chake pansi pa Bush Administration pofuna kuchepetsa kulandira chithandizo cham'tsogolo. Woweruza Wachigawo wa US Edward Korman ananenanso kuti FDA inalola kuti ndale zisalepheretse kupanga zisankho.
Mu 2006, akuluakulu a FDA analola kuti zinthu zikhale zosavuta, kumbuyo kwa malonda a Plan B - kulola kuti a zaka 18 kapena kupitapo agule Plan B pambuyo powonetsa umboni wa ukalamba pomwe akufunikiranso mankhwala kwa akazi a zaka 17 ndi aang'ono. Komabe, mu chigamu cha masamba 52, Judge Korman adalamula FDA kuti alolere ana a zaka 17 kuti agule Plan B popanda mankhwala pazinthu zofanana ndi zomwe B Plan B inkapezeka kwa amayi a zaka zoposa 18 akuti, "The FDA mobwerezabwereza ndipo adachedwa kuchepa ndikupereka chisankho pa pulani B chifukwa cha zifukwa. "
Khotilo linanenanso kuti FDA inachoka payekha njira zowonongera zokolola za OTC ndipo bungweli linangopanga chisankho cha Plan B (mu 2006) chifukwa choopseza kutsimikiziridwa kwa Senate kwa Dr. Andrew von Eschenbach kuti akhale mtsogoleri wa FDA. Ndipotu, chisankho cha 2006 chinapangidwa zaka zoposa zitatu pamene bungwe la Bush linatsutsa FDA kuvomereza Plan B, kutchula "zotetezeka," ngakhale FDA alangizi othandizira adalimbikitsa kuti pasakhale zaka zomwe angathe kugula Plan B. Choncho, woweruzayo adalamula bungweli kuti liwone ngati akufuna kupanga chithandizo chodziletsa mwachisawawa popanda kuperewera kwa zaka. A FDA anayankha kuti akuyang'ana chisankho cha woweruzayo. Korman ananenanso kuti lamulo lake liyenera kutsatiridwa mkati mwa masiku 30. Izi zikuwatsogolera ku chidziwitso cha "Epamous" cha April 2009 cha FDA chomwe chinayambitsa chisokonezo chonse pa omwe angagule Mapulani a B.
Kumene Tikuyimira Lerolino:
Ngakhale kuti lingaliro ladzidzidzi ndilo lingaliro latsopano kwa anthu, likuyankhiratu zokambirana zambiri - monga momwe zinayambira pamene zinayambitsidwa ku United States. Kutsutsana kumachokera ku zikhulupiriro za anthu ngati ayi kapena ayi Bungwe loyamba (kapena mapiritsi a m'mawa) limathetsa mimba.
Kulera kwadzidzidzi kumakhalabe nkhani yokhudzidwa kwambiri komanso yotsutsana, onse omwe amakhulupirira kuti Pulani B Yodziwitsitsa idzachepetsa chiwerengero cha mimba zosayembekezereka ndi kuchotsa mimba ndi otsutsa omwe amakhulupirira kuti kugwiritsa ntchito Plan B imodzi, kumakhala ngati kuchotsa mimba . Kusiyana kumeneku kumayambitsa kutsutsana kumeneku kumagwiritsa ntchito njira zomwe zimachitika mofulumira. Mgwirizanowu ukutentha kwambiri moti unatha kuthetsa chisankho cha FDA ponena za Plan B, ndikusiya bungwe kuti lizitsutsidwa kuti lilole ndale kuti liwongolera zochita zawo m'malo mwa sayansi.
Mwatsoka, chikhulupiliro cholakwika chakuti kubereka kosayembekezereka kumachotsa mimba kwalepheretsanso kupeza ndi kugwiritsa ntchito Mapulani a B Gawo Loyamba pamene anthu ambiri akupitiriza kusokoneza mapiritsi a m'mawa ndi piritsi yochotsa mimba (RU486 ). Pamene pulogalamu ya mimba imatha kuthetsa mimba ndipo imagwiritsidwa ntchito pokhapokha atatha kukhazikitsa mimba (ndipo osapitirira masiku 49 kuchokera kumapeto kwa nthawi ya kumayi), ndondomeko B yotsimikiziridwa kuti imateteza mimba ikadutsa masiku atatu kapena asanu pambuyo kugonana popanda chitetezo. Sichidzavulaza mimba yomwe ilipo kale.
Ndipotu, akatswiri azachipatala amaona kuti kutenga mimba kumakhazikitsidwa pambuyo pa kukhazikitsidwa kwa dzira la feteleza. Ovomerezeka a kulera kwachangu amakhalabe olimba powauza anthu kuti Mapulani a B-One-Step si wothandizira mimba. Akuluakulu azachipatala akufotokoza kuti kuchotsa mimba ndiko kusokoneza kwa dzira lopangidwa ndi feteleza. Izi zikutanthauza kuti sizingatheke kuti Pulani B Yotsimikiziranso kuthetsa mimba kuyambira, mankhwala, mimba sichipezeka. Ndondomeko ya boma, malinga ndi akatswiri azachipatala, imalongosola mankhwala, mankhwala ndi zipangizo zomwe zimachitika musanakhazikitsidwe monga zowonetsera kuti pakhale mimba osati mawonekedwe omwe amathetsa mimba.
Ndondomeko B Njira Yodziwikiratu ndi njira yotetezeka komanso yothandiza amayi kuti asatenge mimba yokhayokha atatha kuchita chiwerewere chosatetezeka kapena akulephera kuthana ndi kubereka ndipo zatsimikiziridwa kukhala ndi njira yayikulu yomwe yathandizira kuchepetsa nambala kapena mimba zosafunikira monga chiwerengero cha mimba zomwe zikanati zichitike ngati mimba izi sizilepheretsedwa kupyolera mu kugwiritsa ntchito chithandizo chodzidzimutsa.
Choncho, ndani angagule ndondomeko B yotsimikizika?
Kuyambira pa June 20, 2013, a FDA avomereza ntchito ya Teva yowonjezerapo ndikuvomerezedwa ndi Mapulani a B Bwalo Loyamba lopanda kulembedwa. Izi zikutanthauza kuti amayi a mibadwo yonse angathe kugula Mapulani a B Bwalo limodzi, zomwe tsopano ziyenera kukhala mu njira ya kulera / gawo la mankhwala osungirako mankhwala.
Pa February 25, 2014, a FDA adalengeza kuti njira yowonjezera njira yowonjezera (Njira Yanga ndi Chotsatira Mmodzi Mmodzi) tsopano idzapezeka popanda chilolezo kapena zaka zoletsedwa zakale - ngakhale kuti bungwe likufuna kuti izi zikhalepo pa malemba awo omwe amagwiritsidwa ntchito amagwiritsidwa ntchito kwa amayi a zaka zapakati pa 17 ndi zapakati. Tenganipo ntchito imapezekanso OTC kwa zaka zirizonse, koma chifukwa zimapangidwa ndi Teva, sizichita
- Kodi ndikuti mungagule bwanji ndondomeko B Bwalo limodzi ndi dongosolo la generic B gawo limodzi?
- Mmene Mungagwiritsire Ntchito Plan B Yoyamba, Chosankha Chokha Chokha, ndi Njira Yanga?
Kotero ... ngati mukufunika kugula zobereka zachangu, zowonjezera ndizotsatira:
- Pulani B Yoyamba - ingagulidwe OTC (popanda mankhwala) kwa anthu a msinkhu uliwonse.
- Njira Yanga , Chitani Zotsatira ndi Chotsatira Chinthu Chokha (Pulani B Zojambula Zoyamba Zowonjezera) - zikhoza kugulidwa OTC, (popanda mankhwala) kwa anthu a msinkhu uliwonse.
- Pulani B generic Chotsatira Chotsatira (mapiritsi aŵiri ochiza pangozi) - ilipo kumbuyo kwa mankhwala a mankhwala, popanda mankhwala, kwa anthu a zaka 17 kapena kuposerapo. Mankhwalawa amafunikira kwa anthu osapitirira zaka 17.
Zotsatira:
Ma CD A DA. [10-03-2013] "Buku la Orange: Njira Zomveka Zogwiritsira Ntchito Mankhwala ndi Zomwe Zikugwirizana ndi Matenda Oyenera."
Chipinda cha FDA. [04-22-2009] "Kusinthidwa kwa FDA Action pa Mapulani a B (levonorgestrel)." Yapezeka 10/6/13.
Chipinda cha FDA. [06-24-2009] "FDA ikuvomereza Mavitamini Achilendo-Ndiwo Mapulani a Plan B Odzimangirira Pakati pa Akazi Azaka Zaka 17 ndi Pansi." Yapezeka 10/6/13.
Tummino v. Torti , 603 F. Supp. 2d 519 (EDNY, Mar. 23, 2009). Yapezeka 10/6/13.