A Amurka, tarihin hana haihuwa ta hanyar gaggawa ta haifar da rikici , ta watsar da muhawarar siyasa da kuma haifar da hukunci. Halin yanayin gaggawa na gaggawa ya faru ne, a wani ɓangare, don ko mutane sunyi imani da cewa kwayoyin safarar kwayoyin sunyi aiki don hana hana daukar ciki ko kuma ta dakatar da ciki wanda aka riga ya kafa.
Shirye-shiryen B Mataki ɗaya (watau kwayar safiya) ana rikice rikice tare da RU486 (watau kwayar zubar da ciki). Wadannan magunguna biyu ba iri ɗaya ba ne kuma kowannensu yana aiki gaba ɗaya daban-daban idan yazo ga tsarin haifuwa.
Komai komai abin da ka ke da shi, tarihi na gaggawa ta hanyar hana ta gaggawa da amincewa da FDA a Amurka ya zama hanya maras kyau. Tushen gaggawa na gaggawa na gaggawa na iya haifar da nazarin ilimin dabba a cikin shekarun 1920, duk da haka an fara amfani da mutum a shekarun 1960. Don haka gyarawa, wannan yana iya kasancewa mai tsauri ...
Lokaci na lokaci: Tarihi na Ƙarƙashin Cutar
- Tsakanin shekarun 1960: Ana amfani da maganin rigakafi na gaggawa a matsayin magani ga masu fyade don hana daukar ciki mara ciki . Doctors za su rubuta wani babban kashi na estrogen bayan fyade. Ko da yake an gano hakan a matsayin mai tasiri, akwai kuma mummunar tasiri.
- Tun farkon shekarun 1970: An gabatar da tsarin Yuzpe, wanda ya hada da haɗarin haɗarin hormone kuma ya maye gurbin hanyoyin yin amfani da maganin gaggawa na gaggawa ta Estrogen na shekarun 1960.
- Ƙarshen shekarun 1970: Doctors sun fara bayar da jan ƙarfe na IUD a matsayin hanyar kawai ba tare da hormonal ba.
Fast Sauya Biyu Shekara ...
- Fabrairu 25, 1997: Tare da manufar karfafa masana'antun don yin maganin gaggawa a cikin gaggawa, FDA ta rubuta a cikin Federal Register cewa Kwamishinan ya ce, "ya tabbatar da cewa wasu haɗuwar maganin da ke dauke da ethinyl estradiol da norgestrel ko levonorgestrel suna da lafiya da kuma tasiri don amfani da su muniyar haihuwa ta gaggawa " da kuma cewa FDA na neman " mika sababbin aikace-aikace na miyagun ƙwayoyi don wannan amfani. "
Hukumar ta kara da cewa ta yarda da kwamitin Shawarar shawara na FDA na Yuni 28, 1996 wanda ya yanke shawarar cewa za'a yi amfani da tsarin jarabawan gaggawa guda huɗu a cikin aminci da kuma amfani dasu sosai a matsayin maganin rigakafin gaggawa - yana ba da amincewar "amfani da lakabi" Dokar kwayoyin haihuwa wadda ke dauke da .05 MG na ethinyl estradiol da .50 MG na norgestrel (2 kwayoyi yanzu / 2 kwayoyi a cikin 12 hours); .03 MG na ethinyl estradiol da .30 MG na norgestrel (4 kwayoyi yanzu / 4 a cikin sa'o'i 12);; 03 mg na ethinyl estradiol da 15 na levonorgestrel (4 kwayoyi yanzu / 4 a cikin sa'o'i 12); da .03 MG na ethinyl estradiol da .125 MG na levonorgestrel (kwayoyi 4 a yanzu / 4 a cikin sa'o'i 12). A wannan lokacin, FDA ta ba da umarni game da yadda za a iya amfani da kwayoyi masu zuwa a matsayin maganin gaggawa: Ovral, Lo / Ovral, Nordette, Levlen, Triphasil, da Tri-Levlen.
Duk da haka, FDA ta kuma lura, a cikin sanarwar Filanin Tarayya , cewa tana ƙaryar wani watan Nuwamban 1994 ya roki hukumar ta bada izini ga masana'antun wasu haruffan maganin haifa don canza lakabin su don sun hada da umarnin yadda za a yi amfani da kwayoyin sunadarin a matsayin maganin gaggawa. .
- Satumba 2, 1998: Kitar da aka yi wa gaggawa ta gaggawa ta zama kyawun samfurin FDA musamman don maganin hana haihuwa ta gaggawa. Bayan yanayin tsarin Yuzpe, Kitar Kayan Kwance na gaggawa da aka samu ta ƙunshi jarrabawar zubar da ciki, takaddama "Littafin Bayani na haƙuri" da kwayoyi hudu (kowanne dauke da 0.25 MG na levonorgestrel da 0.05 MG na ethinyl estradiol) - 2 su zama dauka nan da nan kuma 2 za a dauki sa'o'i 12 bayanan. {* Lura: wannan kit ɗin ba ta samuwa ba.}
- Yuli 28, 1999: FDA ta amince da shirin B a matsayin farkon hanyar progestin-kawai hanyar maganin hana haihuwa ta gaggawa a Amurka.
- Fabrairu 14, 2001: Cibiyar Harkokin Tsarin Harkokin Harkokin Kasuwanci ta tanadar da takaddama na Citizen tare da FDA a madadin sababbin likitocin kiwon lafiya 70 da kungiyoyin kiwon lafiyar jama'a don tsara shirin B a kan kaya.
- Afrilu 21, 2003: Barra Laboratories (sa'an nan kuma mai tsara Shirin B) ya bada aikace-aikacen tare da FDA don sauya Shirin B daga takardun magani zuwa matsayin ba da takardar shaidar ba.
- Disamba 2003: Gwamnonin shawarwari na FDA guda biyu, kwamishinan kula da lafiyar kula da lafiyar yara da kuma kwamiti na miyagun ƙwayoyi, wadanda suka amince da cewa shirin B yana da lafiya kuma yana da tasiri. Kotun FDA ta 23-4 don bayar da shawarar cewa an sayar da shirin B a kan-counter. Manyan ma'aikatan FDA, ciki har da John Jenkins, shugaban ofishin FDA na New Drugs, sun yarda da shawarwarin.
About 6 Months Daga baya ...
- Mayu 2004: FDA ta ba da wasikar zuwa Laboratories na Barr, ta hana karbar sayar da takardun shaida na kamfanin OTC da kuma nuna damuwa game da lafiyar matasa da kuma jima'i. An yanke wannan shawarar duk da binciken da ya nuna shirin B bai kara karuwa ba ko kuma canza mata amfani da sauran hanyoyin sarrafa haihuwa . Wannan matsin da FDA ta yi don kauce wa bayanan kimiyya da kuma kwarewar masana sun jawo wuta daga al'ummar kimiyya. Cibiyar Kwalejin Kwararru ta Amurka da Masanan sunyi kira " yanke hukunci " da kuma "lakabi mai duhu a kan labarun wata hukuma mai shaida kamar FDA."
- Yuni 15, 2004: Sanata Patty Murray da Hillary Clinton sun bukaci Gwamna Ayyukan Gwamna (GAO) su fara binciken a cikin watan Mayu na shekarar 2004 ta amincewa da aikace-aikace na Barr Laboratories don tsara shirin B ba tare da takardun magani ba.
- Yuli 2004: Kamfanin Barr Laboratories ya gabatar da takardun da aka yi amfani da su don yin la'akari da shawarar da FDA ta bayar domin neman matsayin OTC ga mata masu shekaru 16 da haihuwa. Shirin FDA don yanke shawara da za a yi ta watan Janairu.
- Agusta 2004: Wani labarin likita na gaggawa a cikin mujallar, American Family Physician ya bayyana cewa "FDA ta yayyana sharuɗɗa 13 na magance maganin gaggawa don kare lafiyar da inganci lokacin amfani da cutar ta hanyar gaggawa" kuma ya kara da Alesse, Levlite, Levora, Trivora, Ogestrel, Low Ogestrel, da Ovrette zuwa asali na Fabrairu 1997 FDA jerin kwayoyin da za a iya amfani dasu-lakabi da takaddama na gaggawa.
The Plot Thickens a 2005 ...
- Janairu 2005: FDA ba ta yanke shawara kan aikace-aikacen da aka tsara na Barr Laboratories ba. A lokacin da aka yanke shawara, Sanata Patty Murray, da Hillary Clinton sun sanya hannu a kan zabar Lester Crawford don zama Kwamishinan FDA. Cibiyar Tsarin Harkokin Tsarin Harkokin Kasuwanci kuma ta yi amfani da fayiloli akan FDA saboda rashin nasarar haɗu da kwanakin watan Janairu da kuma rashin watsi da kimiyya da kuma rike da tsarin B zuwa wani tsari daban-daban fiye da sauran kwayoyi.
- Yuli 2005: Sanata Clinton da Murray sun dauki nauyin Crawford (wanda Majalisar Dattijai ya tabbatar da ita) daga bisani Sakataren Lafiya da Ayyukan Dan Adam Michael Leavitt ya alkawarta musu cewa FDA za ta yanke shawarar ranar 1 ga Satumba, 2005.
- 26 ga Agusta, 2005: Maimakon sanar da yanke shawara game da aikace-aikacen da aka sake dubawa, FDA ta dakatar da shawararsa, ba tare da jinkiri ba don shigar da jama'a. Kwamishinan Crawford ya yarda cewa "bayanan kimiyyar da aka samo ya isa don tallafawa amintaccen shirin yin amfani da shirin B a matsayin samfurin da aka yi amfani da shi," amma FDA har yanzu ya kasa bada dama ga hanya ta OTC, maimakon zabar sake dakatar da wannan shawara. Crawford ya bayyana cewa, hukumar ba ta iya yanke shawara game da amincewa da aikace-aikacen ba har sai an sake sake dubawa game da "matsalolin warware matsalar da manufofi" . Kodayake hukumar ta FDA ta amince da matsayin OTC na shirin B a kan kuri'un 23 zuwa 4, Crawford ya zaɓi ya mamaye kwamitinsa kuma ya ci gaba da shirin B a matsayin likita.
- Satumba 1, 2005: Mataimakin Mataimakin Mataimakin Mata na FDA na Dokta Susan Wood ya yi murabus saboda rashin amincewa da shawarar Crawford na jinkirta yanke shawara. Dokta Wood ya yi iƙirarin cewa "ma'aikatan kimiyya [a FDA] an rufe su daga wannan yanke shawara" da kuma sanarwar Crawford, "sun kasance tsangwama a cikin yanke shawarar yanke shawara." A wata ganawa ta gaba, Dokta Woods ya bayyana yawancin Mataimakinta suna "damuwa sosai game da jagorancin hukumar," kuma a cikin imel zuwa FDA ma'aikata da ma'aikata, ta tabbatar da murabus ta ta ce ta "ba za ta iya kasancewa a matsayin ma'aikacin bincike na kimiyya da na asibiti ba, kuma an kimanta shi sosai don amincewa da ma'aikata masu sana'a a nan, an soke su. "
- Satumba 9, 2005: Sanata Murray da Clinton, yanzu sun hada da 11 daga abokan aiki a Majalisar Dattijai na Amurka, suka yi kira ga Amurka ta GOA ta saki binciken binciken da ya bincikar FDA ta amince da shirin B na B. A cikin wasika ga Gao, 'yan majalisar sun nuna damuwa cewa shekaru fiye da biyu ne, kuma FDA ta ci gaba da jinkirta yanke shawara na shirin B. Wannan damuwa ya kara da cewa fiye da sababbin kungiyoyin kiwon lafiya 70 sun goyi bayan yin amfani da Shirin B, Shirin bayanan kimiyya wanda yake samuwa don yin amfani da Shirin B a matsayin samfurin OTC, kuma kwamitin kwamitin shawara na kimiyyar kimiyya na FDA ya zabe shi sosai don jin dadin samfur samuwa OTC. Sanata sun rubuta cewa, "Wannan lamarin ya nuna rashin jin dadi da cewa damuwa game da harkokin siyasar sun magance damuwa game da lafiyar jama'a a cikin wannan tsari."
- Satumba 24, 2005: Bayan watanni biyu bayan tabbatarwa, Kwamishinan Crawford ya yi murabus.
- Oktoba 2005: Dokta Frank Davidoff, tsohon mamba na Kwamitin Shawarar Magungunan Kwayoyin Siyasa, ya kuma yi murabus a zanga-zanga. Jaridar New England Journal of Medicine ta ba da bayanin ta biyu, yana cajin FDA tare da "yin izgili game da nazarin shaidar kimiyya." Gao ya kira FDA ta amfani da shirin B "mai ban mamaki," inda ya bukaci Sen. Clinton ya yi sharhi cewa rahoton "ya bayyana ya tabbatar da abin da muke da tsammanin wani lokaci: Kimiyya ta shiga cikin tsarin yanke shawarar FDA akan shirin B."
Whew ... 2005 ya kasance mai ban sha'awa cikin tarihin maganin hana haihuwa ta gaggawa. Mene ne shekara ta 2006 da ke cikin kantin sayar da kwaya?
2006 zuwa 2013
- Maris 2006: Andrew von Eschenbach, aboki da tsohon likita na George W. Bush, an shafe shi don maye gurbin Crawford kuma an nada shi a matsayin Mataimakin Kwamishinan. A karkashin kwanakinsa, ya wallafa wata takardar shaidar da ke ɓoye zubar da ciki da ciwon nono. Sanata Clinton da Murray sashi na Esnbachbach na tabbatar da cewa kwamishinan FDA yana jiran wani shirin B na B.
- Yuni 9, 2006: FDA ta musanta takarda ta Citizen 2001 a karo na farko.
- Yuli 2006: FDA ta ce ba a bukaci sabon dokoki, kuma ranar da za a fara tabbatar da shi, kwamishinan FDA Andrew von Eschenbach ya gayyaci Barr Labs don gyara da kuma sake yin aiki ta hanyar sauya ƙayyadadden ƙayyadaddun shekarun OTC na shirin B zuwa 18 da tsufa .
- Agusta 24, 2006: FDA ta sanar da amincewarta da sayar da shirin B OTC ga wadanda shekarun da suka wuce 18 da haihuwa yayin da wadanda matasa fiye da 18 zasu buƙaci takardun magani don samun wannan hanyar maganin hana haihuwa ta gaggawa.
- Nuwamba 2006: Barr ya fara sasantawa da takardun ba da takardu na shirin B zuwa kantin magani a fadin Amurka.
Fast Gaba 2 Years ...
- Disamba 23, 2008: Kamfanoni na Teva Pharmaceuticals sun sanar da sayen Barr. Shirin B yana da kasuwar Duramed Pharmaceuticals ne, yanzu haka, wani kamfanin na Teva.
Kuma Saga Heats Up Again 3 Months Daga baya ...
- Maris 23, 2009: A cikin Tummino v. Torti , Kotun Tarayyar Turai Edward Korman ta umurci FDA ta bada izini ga 'yan shekaru 17 su sayi shirin B OTC a karkashin irin wannan yanayin da ya riga ya samu ga mata 18 da tsufa. Wadanda ke cikin wannan shari'ar sun tabbatar da cewa FDA na kin amincewa da Yarjejeniya ta Citizen na shekara ta 2001 "ta kasance mai tsaurin kai kuma mai ban sha'awa saboda ba sakamakon sakamakon yanke shawara da kyakkyawar bangaskiya ba." Alkalin Korman ya amince kuma ya bayyana cewa tunanin FDA ba shi da tabbas kuma cewa hukumar ta sanya siyasa kafin lafiyar mata. Ya kuma bukaci FDA ta sake yin la'akari da ƙaryar da aka yi na Citizen.
- Afrilu 22, 2009: Saboda dokar kotu ta tarayya ta umurci FDA ta bawa 'yan shekaru 17 damar sayen Shirin B, FDA ta rikitar da kowa da kowa ta hanyar sanar da cewa' yan shekaru 17 suna sayen shirin B OTC. Duk da haka, duk wannan sanarwar ta ƙunshi FDA ta bayyana cewa ya sanar da masu sana'a na shirin B cewa kamfanin zai iya ba da izinin aikace-aikacen da ya dace , kasuwa B ba tare da takardar izini ga mata masu shekaru 17 da haihuwa ba. Wannan sanarwar tana haifar da maganin hana haihuwa ta gaggawa don samun hanyar dawowa cikin hasken rana.
- 24 ga Yuni, 2009: FDA ta amince da takardun sirri-kawai amfani da Next Choice , tsarin jigilar shirin B.
- 13 ga Yuli, 2009: FDA ta sanar da amincewa da Shirin B Mataki guda daya (kwayoyin kwayoyin kwayoyi guda daya da sabon tsarin B). A wannan lokacin, FDA ta ba da izini ga hanyar OTC, yana ba mata da maza shekaru 17 ko fiye da su saya shirin B na daya a kantin sayar da kantin magani ba tare da takardun magani ba akan tabbatar da shekarun haihuwa (waɗanda ke karkashin 17 suna buƙatar takardar izini).
- 28 ga Yuli, 2009 : FDA ta amince da sayar da Kasuwanci na gaba na ATC, nau'in tsara bidiyon B, ga dukan waɗanda shekarun 17 ko tsufa ('yan mata 16 da matasa suna buƙatar takardar sayen magani don samun Next Choice).
- Satumba 2009: Shirin B Ɗaya daga cikin matakai yana samuwa a cikin kantin sayar da kaya a duk fadin kasar, kuma samar da tsohon shirin B yana tsayawa.
2009 ya zama babban shekara a tarihin maganin hana haihuwa ta gaggawa. Bari mu matsa a gaba game da shekara guda daga baya ...
- Agusta 16, 2010: FDA ta bada amincewa ta karshe ga sabon hawan gaggawa, Ella . Ella yana samuwa ne kawai da takardar sayan magani kuma yana samuwa a kan kantin magani a cikin watan Disamban 2010. Yayi aiki da bambanci fiye da Shirin B na daya.
Yanzu, Ka Yi Shirye-shiryen Na 2011 (Tana Fuskatuwa, Har yanzu) ...
- Fabrairu 7, 2011: Teva Pharmaceuticals ya aika da sabon aikace-aikacen miyagun ƙwayoyi tare da FDA da ake nema a ba da Shirin B Ɗaya daga cikin Mataki a kan-da-counter, ba tare da ƙuntatawa ba (kuma ya haɗa da ƙarin bayanan da ya tabbatar da amincinsa na duk lokacin amfani da shi).
- 7 ga watan Disamba, 2011: FDA ta yanke shawara ta ba da iznin Teva Pharmaceutical ya karbi dukkanin ƙuntatawar haihuwa kuma ya ba da izinin B-Sanya daya da za'a sayar da shi, ba tare da takardun magani ba. Duk da haka , a cikin hanyar da ba a taɓa yi ba, Ma'aikatar Lafiya da Sakataren Harkokin Kasuwancin Kathleen Sebelius sun kulla yarjejeniya da FDA kuma sun umarci hukumar ta musanta bukatar Teva. Sebelius ya bayyana rashin bayanai don taimakawa wajen ba da Shirin B Ɗaya daga cikin Mataki don sayarwa a kan dukkanin 'yan mata masu haihuwa. Ta kuma bayyana cewa 'yan mata a matsayin matashi 11 suna iya samun yara kuma ba su ji cewa Teva ya tabbatar da cewa' yan mata zasu iya fahimtar yadda za su yi amfani da wannan samfurin ba tare da jagoranci ba. Wannan yanke shawara ya tabbatar da halin da ake bukata na yau da kullum akan shirin B daya (da kuma Zabi na gaba) dole ne a sayar da shi a bayan bayanan kantin magani bayan mai magani ya iya tabbatar cewa mai sayen yana da shekaru 17 ko tsufa. Disamba 12, 2011: FDA ta sake musun Citizen Taron, kuma ya bukaci a sake dawo da lamirin Tummino v. Hamburg ranar 8 ga Fabrairu, 2012.
Don haka, shekara ta 2012 za a fara tare da wannan kotu a inda masu karar sun gabatar da motsi don dakatarwa na farko wanda zai ba da damar samun izinin OTC ga duk wanda ya yi amfani da gaggawa na gaggawa a cikin kullun (duka guda biyu). ..
- Fabrairu 16, 2012: Alkali Korman ya shafi "Ƙa'idar don nuna dalilai" yana so ya san "dalilin da ya sa ba za a umurci FDA ba don tsara shirin B don mutanen da binciken da aka gabatar wa FDA na iya fahimta lokacin amfani da Shirin B ya dace da umarnin don amfani. "
- Maris 9, 2012: Teva fayiloli sun gyara aikace-aikacen don yin shirin B daya-mataki samuwa ba tare da takardar izini ba ga masu amfani da shekaru 15 da haihuwa kuma don yardarta ta samuwa a cikin ɓangaren iyali na kantin magani (tare da kwaroron roba , yau Sabo , kashe jini , kwakwalwan roba na mata , da kuma lubricants ) maimakon bayan bayanan kantin magani, amma an tabbatar da tabbacin shekaru a lokacin biya.
- 12 ga Yuli, 2012: FDA ta amince da amfani da ƙwaƙwalwa na gaggawa na Next Choice One Dose , wani ma'auni guda ɗaya kamar Shirin B na Ɗaya daga cikin matakai, kuma yana ba da lambar yabo na OTC / bayan bayanan kantin magani ga wadanda shekarun 17 suka tsufa ba tare da takardar sayan magani ba.
Kuma tare da wannan, zan jagoranci ku cikin shekara ta 2013, da kuma ƙarshen tarihin hana haihuwa ta hanyar gaggawa, da kuma tsawon tafiya mai sauri don samun inda yake a yau ...
- Fabrairu 22, 2013: FDA ta amince da amfani da hanyoyi na gaggawa na Wayata ta , wanda ya dace da Shirin B na daya, kuma yana ba da lambar yabo na OTC / a bayan asibiti na wadanda ke da shekaru 17 ko kuma ba tare da takardun magani ba.
- 5 ga watan Afrilun 2013: Gwamna na Kotun Amurka Edward R. Korman ya juya shawarar FDA na kin amincewa da kudurin Citizen kuma ya umurci hukumar ta da kwanaki 30 don ba da izini don sayar da kaya ga wadanda ba su da kariya. Ya lura da yanke shawara Sakatariyar Sebelius a matsayin '' yan siyasa, da rashin fahimtar kimiyyar kimiyya, da kuma saba wa tsarin mulkin. Alkalin kotun Korman ya tsawata wa hukumar ta FDA don jinkirta jinkirinsa, yana jaddada cewa shekaru 12 da suka gabata ne bayan da aka ba da takarda ta Citizen.
- Afrilu 30, 2013: Wata rana ko biyu kafin a buƙaci hukumar ta bi umarnin kotu na Afrilu 5 ga watan Afrilu, 2013, FDA "ta dace" ta amince da aikace-aikacen gyara ta Teva , ta yarda sayarwa shirin B Ɗaya-mataki a kan shiryayye ba tare da takaddama ga mata masu shekaru 15 da haihuwa. Da karfi da tabbacin cewa amincewar Teva ta zama "mai zaman kanta" kuma "yanke shawara ba ta nufin magance hukuncin da alkalin ya yanke." Daidai ne cewa FDA ta bai wa Teva bukatar wannan lokaci? Hmm?
- Mayu 1, 2013: Kwanaki kafin kafin FDA ta bi hukuncin kotu na Kwamandan Afrilu 5, Ma'aikatar Shari'a na Amurka ta yi kira kuma ta nemi a dakatar da umurninsa, saboda haka ba za a samu FDA ba saboda rashin bin kotu.
- Mayu 10, 2013: Alkali Korman ya musanta bukatar DOJ na tsayawa , yana kiran wannan aikin "frivolous" da kuma wani ƙoƙarin da FDA yayi don jinkirta tsarin yanke shawara.
- Mayu 13, 2013: Ma'aikatar Shari'a ta kaddamar da roko tare da Kotun Kotu na Kotun Koli ta Amurka a Manhattan. Kotun ta kara yawan hukuncin kotu na Korman har zuwa ranar 28 ga Mayu, 2013.
- Yuni 5, 2013: Kotun kotu ta yanke hukuncin kisa akan dokar ta DOJ don tsayawa da umarni don tayar da dukkanin ƙuntatawar haihuwa kuma bada izinin cikakkun matsala game da rikice-rikice na miyagun kwayoyi, amma ba saboda gaggawa guda ɗaya ba. Yin amfani da rigakafi - An yanke hukuncin kisa na Korman game da rigakafi na gaggawa guda daya an dakatar da shi a lokacin jinkirin sakamakon yunkurin DOJ.
- Yuni 10, 2013: Dokar ta DOJ ta watsar da roƙonta kuma ta amince da biyar da Kundin tsarin OTC wanda ba shi da tabbacin Sanya B daya-mataki idan har kwayoyin halitta sun kasance ƙuntataccen shekaru kuma a baya bayanan. FDA kuma ta bukaci Teva don rubuta wani ƙarin aikace-aikacen da ake buƙatar ba shekaru ko kwangila ba.
Drum roll don Allah ... lokaci a cikin tarihin maganin hana haihuwa ta gaggawa da muke jagorantar zuwa - YES, yana nan a nan ...
- Yuni 20, 2013: FDA ta amince da shirin B Ɗaya daga cikin matakai na tallace-tallace na kan-tallace-tallace ba tare da hana hani ba. Har ila yau, hukumar ta bayar da kyaututtuka na shekaru uku, ga Teva, don sayar da ku] a] en B, na B-daya-Step OTC. Masu sana'a don 1-kwaya nau'ikan misalai masu dacewa zasu iya samar da ƙarin FDA aikace-aikacen don tallace-tallace kan-tallace-tallace tun bayan da bayanan Teva ya ƙare a watan Afrilu 2016.
- Fabrairu 25, 2014: A ƙoƙari na ƙyale matsayi na OTC na Zabi daya da kuma hanya ta (Darin jigilar kwayoyi 1-Shirye-shiryen B na daya), FDA ta aika wasikar zuwa ga masana'antun waɗannan samfurori da ke nuna cewa Shirin Teva game da haɓakaccen abu ne "mawuyacin hali" kuma "maɗaukaki." Kamfanin ya amince da irin wadannan hanyoyin da za'a sayar da su ba tare da sayarwa ko ƙuntatawa ba a ƙarƙashin yanayin da masana'antun suka nuna akan lakabin samfurin cewa ana amfani da wannan ƙwayar cutar gaggawa ga mata masu shekaru 17 da haihuwa. Yin amfani da wannan aikin da aka yi amfani da shi a kan kunshin yana riƙe da yarjejeniya ta musamman ta Teva yayin da yake ba da izini don sayar da wadannan hanyoyin da za a sayar da su, ba tare da takardun magani ba ko bukatun zamani.
Tarihin na hana haihuwa ta gaggawa ya ƙunshi gagarumin nasara da wasu nasara. A ƙarshe, kasancewar wannan maganin ƙwaƙwalwar mahimmanci yana aiki ne a matsayin rigakafi na rigakafin ciki da zubar da ciki.
Sources:
Ma'aikatar Lafiya da Ayyukan Dan Adam. "Abubuwan da ake amfani da su a cikin kwayoyi; Wasu sun hada da maganin ƙwaƙwalwar maganin ta hanyar amfani da ita azaman ƙwaƙwalwar haihuwa ta gaggawa "; Lura. Tarayya Register . Fabrairu 25, 1997; kundi 62: babu 37: 8610-8612. Samun shiga 10/11/12.
DG Weismiller. "Cibiyar Harkokin Cutar Gida." Jami'in Kasuwancin Amirka . 2004 Aug 15; Vol. 70 (4): 707-714. Samun shiga 10/11/12.
FDA Newsroom. [Agusta 26, 2005]. "FDA ta dauki mataki kan shirin B." Sanarwar da kwamishinan FDA, Lester M. Crawford, ya bayyana. Samun shiga 10/11/12.
FDA Newsroom. [Afrilu 30, 2013]. "FDA ta amince da shirin B Kwancen gaggawa na daya-mataki ba tare da takardun magani ga mata masu shekaru 15 da haihuwa ba." An shiga 10/11/12.
J. Trussell, F. Stewart, F. Guest, da kuma RA Hatcher. "Dokar maganin gaggawa na gaggawa: Masiha mai sauki don rage karuwancin da ba a dade ba." Shirye-shiryen Yanayin Iyali . 1992; 24: 269-273. Samun dama ta hanyar biyan kuɗi.
PFA Van Look da H. von Hertzen. "Ƙungiyar gaggawa ta gaggawa." Labarin Jaridar Birtaniya . 1993; 49: 158-170. Samun dama ta hanyar biyan kuɗi.
P. Murray. [Satumba 9, 2005]. "Clinton, Murray da Senators 11 sun bukaci GAO don saki Audi na Shirin B na Ƙaddamarwa." An shiga 10/11/12.
RL Mackenzie. [Satumba 2, 1998]. "Kwaskuren gaggawa na gaggawa - Na farko da kawai samfurin ƙwayar gaggawa - FDA ta amince." An shiga 10/11/12.
Tummino v. Hamburg (A'a. 12-CV-763) Matsala: 13-1690 (Kotun Kotu ta Kotun {asar Amirka ta Harkokin Kasuwanci ta Biyu a Yuni 5 2013). Samun damar 6/6/13.
Tummino v. Hamburg , No. 12-CV-763 (ERK) (VVP) (EDNY Afrilu 4, 2013). Samun shiga 10/11/13.
Tummino v. Torti , 603 F. Cik. 2d 519 (EDNY, Mar. 23, 2009). Samun shiga 10/11/13.