Kuronga Nenzira Yakasununguka Kubata Maze
Chirongwa B Chimwe Chimwe Chichigamuchirwa neAAA musi waJuly 13, 2009, zvichichinja nzvimbo yekare yemapiritsi maviri. Iyi yekuvhara kwekukurumidzira inosanganisira imwe piritsi yemuromo ( levonorgestrel tablet, 1.5 mg).
Muna July 2012, FDA yakabvumira Next Choice One Pose , February 2013, FDA yakagamuchira My Way , uye muna February 2014, FDA yakagamuchira Take Action - yose mitatu ndiyo nzira dzepiritsi imwe chete yekugadzira B Bumwechete.
Panewo mamwe maitiro akadai anonzi AfterPill, asi izvi zvinogona kutengwa chete paIndaneti.
Kubvira muna 2006, vakadzi nevarume vane makore gumi nemana kana kupfuura vakabvumirwa kutenga Plani B pamusoro pe-counter kumapromita eko (uye avo vari pasi pemakore gumi nemasere vanoda rubatsiro kubva kuchiremba wavo). Purogiramu B (pamwe chete nekugadziriswa kwayo, Purogiramu B One-Step) inogadzirwa neTeva Pharmaceuticals.
Iye zvino, chero munhu (wezera chero ripi zvese) anogona kutenga Plani B Chimwe Chimwe Chete kana chimwe chezvinyorwa zvaro zvitatu, Tora Action, My Way kana Next Choice Rimwe Dose, pamusoro-the-counter, pasina mushonga. Nzira yekubvumidza inoita kuti kuwanike kweChirongwa B Chimwe Chengetedzo, pamusoro pe-counter-pasina chikamu chezera chakave chakanyanyisa mukukakavadzana nekuvhiringidzika-kusiya vanhu vakawanda vachiri kuvhiringidzika pamusoro pehutano hwehutano hwekukurumidza huri pamwe chete nehutano hwekutora hunoita isu kwatiri kwatiri nhasi.
Ikoko Kukonzwa Kwakatangira:
Vanhu vazhinji vakanyengerwa pamusoro pekuti ndiani angatenga Purogiramu B Chimwe Chikamu.
Izvo kuvhiringidzika pakutanga kwakagadziriswa kubva kuDAA kuzivisa muna April 2009 kutaura kuti FDA ichabvumira Mugadziri weBurongwa B kuti aite Plan B inowanikwa kuvakadzi 17 nevekare vasina mushonga. Ichi chirevo cheDaeda chinotungamirira vazhinji kuti vatende kuti vane makore gumi nemashanu vanogona kutenga Purogiramu B pamusoro pe-counter. Vanhu vazhinji havana kuziva kuti iyi haisi iyo nyaya kusvikira FDA ichizivisa, musi waJune 24, 2009, iyo sangano rakabvumidza Next Choice , mishonga-inongogadziriswa chete yechirango chekudzivirira chirongwa B, kune vakadzi vane makore 17 uye vaduku.
Izvo kuvhiringidzika kwakasimuka zvichienderana nezvinyorwa zvinotevera kubva muJune 2009 kusunungurwa kwehurukuro:
"Muna 2006, chirongwa B chakagamuchirwa nekuda kwekusashandiswa kwevakadzi kusvitsa makore gumi nemana kana kupfuura.Chirongwa B chakaramba chichiwanikwa sechiremba-chigadzirwa chete chevakadzi vane makore gumi nemasere ne pasi. Kubvumirwa kwezuva nhasi kunobvumira kushandiswa kwemishonga-inogadzirwa chete kune vakadzi vane makore 17 uye pasi. "
Iri dhidhiyo reDAA rinotungamirira vakawanda kuti vashamise - kana FDA yakatobvumidza vanhu vanopfuura makore gumi nematanhatu kuti vatenge Plan B pamusoro pe-counter, saka nei FDA ichizivisa icho kusvikira ikozvino, OTC Plan B kushandiswa kwairehwa kune avo ane makore gumi nemasere?
Siobhan DeLancey, uyo akanyora musangano weDDA rekudhinda achizivisa kugamuchirwa kweChirongwa B chairo, vakapindura mubvunzo uyu nekungoti, "zvisinei kuti chii chakaitwa neDefA munaApril apfuura, ane makore gumi nemana ane makore makumi maviri nemashanu asina Ronga B ".
Mubvunzo wakaramba uripo, kana izvi zvaive, zvechokwadi nyaya, nei FDA yakaratidza kubvumirwa kwayo kuti vane makore 17 vanogona kutenga Plani B?
Tsanangudzo:
Zvinoratidzika kuti zvizhinji zvekuvhiringidzika kwakakonzerwa nekusanzwisisa zvisizvo musi waApril 22, 2009, kuziviswa kweDaily Press yaiti inonzi vakadzi vane makore gumi nemashanu nepamakore vaigona kutenga Plan B kupfuura-the-counter. Ichi chisarudzo cheDFA chaive chikonzero chemudare wedare rehurumende rinorayira FDA kubvumira vane makore gumi nemana kuti vatenge Plan B.
Mutongi Korman akakumbirawo sangano kuti aone kana mapiritsi aifanira kuwanikwa pamusoro pe-the-counter kune vakadzi vezera rose. Dare rekutonga rakagamuchira kuti chisarudzo chekutanga cheDFA chekudzivirira kukwanisa chaive chakavakirwa mune zvematongerwo enyika uye kwete nesayenzi.
Muchiziviso chemajeri, mutemo weDFA unotsanangura,
"Maererano nedare redare, uye maererano nemasayenzi akawanikwa kubvira muna 2005 neCent for Drug Evaluation nekutsvakurudza, FDA yakatumira tsamba kune mugadziri weChirongwa B iyo kambani inogona, pakutumirwa uye kugamuchirwa kushanda kwakakodzera, Mutengo Wechigadzirwa B usina mutemo kuvakadzi vane makore gumi nemakore nemakore. "
Kutenda kuti iyi nhau yaireva kuti vane makore gumi nemashanu vanogona kutenga Plan B kupfuura-the-counter, utano hwehutano hunokurudzira. Cecile Richards, purezidhendi we Plan Plan Parenthood Federation yeAmerica, akatotaura kuti kubvumirwa kwaDFA "chirevo chakasimba kuvakadzi veAmerica kuti hutano hwavo hunouya pamberi pezvematongerwo enyika.Iyo ndiyo nzira iyo inofanira kunge iri.Icho chisarudzo inowanzofungwa-pfungwa rubatsiro rwekudzivirira huwandu hwehutano husina kutarisirwa uye kuchengetedza hutano nekuchengetedzwa kwevakadzi vose. "
Asi, panguva iyoyo, chirongwa B chakanga chichingowanikwa chete kune avo vanopfuura makore gumi nemashanu. The Catch? Zvose izvo FDA zvaireva nechiziviso chazvo ndechokuti sangano racho raizopedzisira richibvumira Mugadziri weBurongwa B kuti atumire chikumbiro chepamusoro-che-sales sales status yeChirongwa B kusvika kune rimwe boka rezera. Paakabvunzwa nezvemamiriro ehurumende iyi, DeLancey (mutauri weDFA) haazoti kana iyi yakanyorerwa kana kwete, asi ingongotaura chete kuti hapana chikwata chekutengesa OTC kune vane makore 17 chakabvumirwa .
Nhoroondo Yezvematongerwe Enyika:
Zvose izvi kuvhiringidzika pamusoro pevanhu vanogona kutenga Purogiramu B Chimwe Chiito chinongova chirevo chekurwisana kwenguva refu uye zvematongerwe enyika pamusoro pekutengesa kweOTC yeBurongwa B. Vatsigiri vezvehutano hwekuberekidza vanowanazve tariro pamusoro pemamiriro ekudzivirira shure mushure meSouth District Court iyo Eastern District yeNew York yakatonga, muna March 23, 2009, kunzwa , kuti FDA inofanira kufungisisa chisarudzo chayo pasi peBush Administration kuti isapedzere kuwanikwa kwekukurumidza kubata pamuviri. Mutongi weDunhu reU.S. Edward Korman akaenderera mberi achiti FDA yakabvumira zvematongerwo enyika kupindira nemigumisiro yadzo yakasarudzwa.
Muna 2006, vakuru veDFA vakabvumira kuti zvive nyore, shure kwe-sales sales yeChirongwa B - kubvumira ivo vane makore 18 nekure kutenga Purogiramu B mushure mokuratidza uchapupu hwezera panguva vachiri kuda mishonga yevakadzi vane makore 17 uye vaduku. Zvisinei, mumutongi wepaji-52, Mutongi Korman akarayira FDA kubvumira vane makore gumi nemashanu kuti vatenge Plan B vasina mishonga pasi pemamiriro akafanana neChirongwa B chaiwanika kuvakadzi vanopfuura makore 18 vachiti, "FDA inowanzoitika uye akambomira kunonoka pakupa chisarudzo paChirongwa B chekufungidzira zvikonzero. "
Dare rakaramba richitaura kuti FDA yakatsauka kubva mumitemo yayo yepamusoro yekuongorora maitiro eOTC uye iyo sangano rakangoita chirongwa cheGurongwa B (muna 2006) nekuda kwekutyisidzira kubata Senate kutsigirwa kwaDr. Andrew von Eschenbach kuva mutungamiriri we FDA. Ichokwadi, chisarudzo cha2006 chakanga chave chichibudiswa kwemakore matatu sezvo Bush administration inopikisa FDA kubvumirwa kweParamende B, ichitsanangura "zvinetso zvekuchengeteka," kunyange zvazvo FDA mazano ekupa mazano akarayira kuti parege kuva nemakore ekugumira kune avo vanogona kutenga Plani B. Nokudaro, mutongi akarayira sangano kuti riongorore kana richiita kuti chirongwa chekudzivirira pamuviri chisina kuwanikwa chingasarudzwa nemakore. I-FDA yakapindura kuti iri kugadzirisa chisarudzo chevatongi. Korman akatonga zvakare kuti urongwa hwake hunofanira kuteverwa mukati memazuva makumi matatu. Izvi zvinotungamirira kune "chisingadikanwi" April 2009 FDA yezvinyorwa zvinoparidzira izvo zvakaita kuti vese vanyatsogadzikana pamusoro pekuti ndiani aigona kutenga Chaizvo B.
Kwatiri Kwatiri Nhasi:
Kunyange zvazvo pfungwa yekukurumidza kubata pamuviri hakusi pfungwa itsva kumagariro evanhu, ichiri kuisa mhirizhonga yakawanda - sezvakangoita apo yakatanga kuiswa kuUnited States. Iyo nharo inobva kuvanhu vanotenda pamusoro pekuti kana kwete chirongwa cheB-One-Step (kana mapiritsi anotevera-mushure) inogumisa kubata.
Emergency contraception inoramba iri nyaya yakakanganisika uye yakakavhiringidza, vose vari vatsigiri vanotenda Chirongwa B Chimwe Chimwe Chinozopedza nhamba yehutachiona husingatarisirwi uye kubvisa pamuviri uye kune vadzivisi vanofunga kuti kushandisa Guramu B Chimwe Chikamu kunowedzera kubvisa pamuviri . Kukonana kunokonzera hurukuro iyi inoratidza nzira dzinobatsira pakubata pamuviri nokukurumidza. Iyi nharo inopisa zvikuru zvokuti yakatokwanisika kupisa maDaDa zvisarudzo pamusoro peChirongwa B, ichisiya sangano rinopomerwa nekubvumira zvematongerwo enyika kutongesa zvisarudzo zvavo panzvimbo yesayenzi.
Zvinosuruvarisa, kutenda kusina kururama kunobvisa kubvisa pamuviri kunokonzera chigadziro kusvika pakuwana nekushandiswa kweGadziriro B Chimwe Chimwechete sezvo vanhu vazhinji vachiri kukanganisa mapepa-mushure memapiritsi nemapiritsi emimba (RU486 ). Kunyange zvazvo piritsi inobvisa pamuviri inoguma pakuguma kwehutano uye inongoshandiswa chete mushure mokunge mimba isimbiswa (uye pasina mazuva anopfuura makumi mashanu kubva pamakore ekupedzisira ekuenda kumwedzi), chirongwa B Chimwe Chito chinoshandiswa kudzivirira kubata pamuviri kana kutorwa mukati memazuva matatu kusvika ku5 pashure pokuita zvepabonde zvisina kudzivirirwa. Hazvizovhiringidzi kubata pamuviri.
Zvechokwadi, nyanzvi dzezvehutano dzinofunga kuti pamuviri unotangwa mushure mokunge kuiswa kweii inobereka yakaitika. Vatsigiri vekudzivirira kwepabonde zvinopfuurira vanoramba vakasimba mukuzivisa vanhu kuti Gadziriro B Chimwe Chito hachisi mumiriri wekubvisa pamuviri. Zviremera zvezvechiremba zvinotsanangura kubvisa pamuviri sekuvhiringidzwa kweiyo yakasimwa mazai. Izvi zvinoreva kuti hazvibviri kuChirongwa B Chimwe Chimwe Chinobvisa kubvisa pamuviri kubva, mune zvekurapa, pamuviri hahupo. Hurumende yehurumende, maererano neyanzvirapa vezvehutano, inotsanangura mishonga, zvinodhaka uye zvishandiso zvinoita zvisati zvasimbiswa sezvirongwa zvekuita pamuviri uye kwete maitiro anogumisa kubata.
Ronga B Imwe-Nzira inzira yakachengeteka uye inobudirira yevakadzi kuti VADZIDZE kutora pamuviri mushure mekuita mune zvepabonde zvisina kudzivirirwa kana kuwanikwa nekukundikana kwekuberekwa uye zvakaratidza kuva nechisarudzo chakakosha chakabatsira zvikuru kuderedza nhamba kana kubata pamuviri usina kudiwa pamwe chete sezvo nhamba yekubvisa pamuviri iyo ingadai yakaitika kana uku kutakurwa kusina kudziviswa kuburikidza nekushandiswa kwekukurumidza kubata pamuviri.
Saka, ndiani angatenga chirongwa B chekutanga-chekutanga?
Kubva munaJune 20, 2013, FDA yakagamuchira teva yekuwedzera yekushanda uye yakagamuchirwa Purogiramu B Imwe-Chikwere chisina kunyora / pamusoro-che-status. Izvi zvinoreva kuti vakadzi vemazera ese vanogona kutenga Plani B Imwe-Nhano, iyo inofanira kunge iri ikozvino mukuronga mhuri / chikamu chezvikwata zvemidziyo.
Musi waFebruary 25, 2014, FDA yakaratidza kuti Purogiramu B Chimwe Chetatu Chimwe Chine nzira (My Way uye Next Choice One Dose) ikozvino inowanikwa pasina mishonga kana chero zvipi zvidzidzo zvezera - kunyange zvazvo sangano rinoda kuti zvinhu izvi zvinosanganise mavara avo anoshandiswa akaitirwa vakadzi vane makore gumi nemashanu kana kupfuura. Tora Gadziriro inowanikawo OTC yezera ripi zvese, asi nokuti rakagadzirwa naTeva, harina
- Ndekupi uye Kutenga Kwazvo Taronga B Chimwe Chimwe Chete uye Chirongwa cheGeneric B Chimwe Chito?
- Mashandisiro Aungaita Purogiramu B Chimwe Chimwe Chete, Kusarudza Chimwe Chete, uye Nzira Yangu?
Saka ... kana uchida kutenga chirongwa chekudzivirira pamuviri nokukurumidza, kubatikana kunotevera:
- Ronga B Imwe-Nhanho - inogona kutengwa OTC (pasina mutemo) kune avo vezera ripi zvaro.
- Nzira Yangu , Tora Chiito uye Zvimwe Zvasarudzwa Rimwe Rudzi (Ronga B Bhuku rimwechete-zvigadzirwa zvemagetsi) - inogona kutengwa OTC, (pasina mutemo) kune vezera ripi zvaro.
- Purogiramu B inotevera Next Choice (maviri-piritsi inobata pamuviri) - inowanikwa mushure mokumesa mishonga, pasina chiremba, kune avo vane makore 17 nevanopfuura. Chirongwa chinodiwa kune avo vanopfuura makore 17.
Sources:
FDA Drug Databases Databases. [10-03-2013] "Orange Book: Approved Drug Products neTherapeutic Equivalence Evaluations."
FDA Newsroom. [04-22-2009] "Yakavandudzwa FDA Action paGadziriro B (levonorgestrel) Matetetsi." Yakasvika 10/6/13.
FDA Newsroom. [06-24-2009] "FDA Inobvumira Generic Chirongwa Chete-Icho Chinyorwa Chegadziriro B Emergency Contraceptive Kwemazana Emakore 17 uye pasi." Yakasvika 10/6/13.
Tummino v. Torti , 603 F. Supp. 2d 519 (EDNY, Mar. 23, 2009). Yakasvika 10/6/13.