I-Mifepristone, lapho ihlanganiswa nephilisi lesibili, isibe indlela evame kakhulu yokukhipha isisu e-US futhi ibilokhu inqunywa kusukela ngaleso sikhathi Roe yachithwa.
Evuma ukubaluleka kwaleli cala, uKacsmaryk, owaqokwa nguMongameli wangaleso sikhathi uDonald Trump, wabuza uMbhapathizi ukuthi angasho yini isibonelo sangaphambili senkantolo esusa umuthi ogunyazwe yi-FDA ngemuva kweminyaka eminingi emakethe.
U-Baptist uvumile ukuthi azikho izibonelo zangaphambilini, kodwa wasola ukuphila isikhathi eside komuthi “ekuhlanganiseni kwamatshe” kwe-FDA yezicelo zangaphambili zeqembu lakhe zokususa umuthi. Leli qembu lafaka isicelo ku-FDA ngo-2002 nango-2019 lifuna ukunqanda ukutholakala kwephilisi.
Abameli be-FDA kulindeleke ukuthi baphikisane ngokuthi ukudonsa i-mifepristone kuzokhuphula ukunakekelwa kokuzala kwabesifazane base-US futhi kubukele phansi ukwengamela kukahulumeni kwesayensi kwemithi kadokotela.
U-Kacsmaryk unikeze uhlangothi ngalunye amahora amabili ukwenza izingxabano zabo – nesikhathi sokuphikiswa – endaweni icala eliphezulu. Umkhiqizi we-Mifepristone, i-Danco Laboratories, uzojoyina i-FDA ekuphikisaneni ngokuthi kugcinwe iphilisi litholakala.
Isinqumo singavela noma nini ngemva kokuphothulwa kwezingxabano. Isinqumo esimelene nomuthi sizodluliswa ngokushesha abameli boMnyango Wezobulungiswa base-US abamele i-FDA, okungenzeka futhi bafune ukuhlala okuphuthumayo ukuze bawumise ukuthi ungasebenzi ngesikhathi icala liqhubeka.
Enye yezimpikiswano ezinkulu zombimbi ngokumelene ne-FDA ukuthi yasebenzisa kabi iziphathimandla zayo lapho ivuma iphilisi ekuqaleni.
I-FDA ibuyekeze umuthi ngaphansi kwalokho okubizwa ngokuthi uhlelo lokugunyazwa okusheshisiwe, olwakhiwa ekuqaleni kwawo-1990 ukuze kusheshiswe ukufinyelela emithini yokuqala ye-HIV. Kusukela lapho, ibisetshenziswa ukusheshisa izidakamizwa zomdlavuza nezinye “izifo ezimbi kakhulu noma ezisongela ukuphila.”
Umfelandawonye, owawuhilelekile ecaleni elaholela eNkantolo Ephakeme ukuba ichithe uRoe, uthi ukukhulelwa akusona isifo ngakho-ke i-mifepristone kwakungafanele icatshangelwe ukuze ivunyelwe ngokushesha.
“Umehluko phakathi kwalezi zifo kanye nokukhulelwa kwe-FDA okuminyanisa … imithetho ye-FDA ayikwazanga ukugqama,” kusho uBaptist etshela uKacsmaryk.
Kepha i-FDA ithi ingxabano yeqembu inephutha emabalweni amaningi. Okokuqala, imithetho ye-FDA ikwenza kucace ukuthi ukukhulelwa kubhekwa “njengesimo sezokwelapha” esingaba yingozi futhi sisongela ukuphila kwezinye izimo.
Okwesibili, ngenkathi i-FDA ibuyekeza umuthi ngaphansi komthetho wawo wokugunyazwa osheshisiwe, ayizange ikusheshise ukubuyekezwa komuthi. Eqinisweni, ukugunyazwa kwafika kuphela ngemva kweminyaka emine yokuxoxisana. Esikhundleni salokho, i-FDA yasebenzisa amandla okulawula ngaphansi kohlelo olusheshisiwe ukuze yengeze imikhawulo eyengeziwe yokuphepha ku-mifepristone, okuhlanganisa nokudinga ukuthi odokotela bagunyazwe ngaphambi kokuyichaza.
Ukulalelwa kwecala kungokokuqala kuleli cala futhi kubhekwe ngabomvu ngamaqembu nhlangothi zombili ngodaba lokuhushulwa kwezisu ngenxa yalokhu ukuguqulwa kwe Roe. Ukukhipha i-mifepristone emakethe kuzonciphisa ukufinyelela kokukhipha isisu ngisho nasezifundeni lapho kusemthethweni khona.
Uma i-Kacsmaryk ilawula ngokumelene ne-FDA, akucaci ukuthi ukufinyelela ku-mifepristone kungancishiswa ngokushesha kangakanani noma ukuthi inqubo izosebenza kanjani. I-FDA inezinqubo zayo zokuhoxisa ukugunyazwa kwezidakamizwa ezibandakanya ukulalelwa kwezingxoxo zomphakathi kanye nezingxoxo zesayensi, ezingathatha izinyanga noma iminyaka.
Uma i-mifepristone ibekwe eceleni, imitholampilo nodokotela abanikeza inhlanganisela bathi bazoshintshela ekusebenziseni i-misoprostol kuphela, omunye umuthi. esetshenziswa ekuhlanganiseni kwezidakamizwa ezimbili. Leyo ndlela yokusetshenziswa kwesidakamizwa esisodwa inezinga eliphansi kancane lokusebenza ngempumelelo ekuqedeni ukukhulelwa kodwa isetshenziswa kakhulu emazweni lapho i-mifepristone ingekho emthethweni noma ingatholakali.
Ngaphezu kokubekela inselele inqubo yokugunyaza i-mifepristone, icala lithatha umgomo ezinqumweni ezimbalwa zakamuva ze-FDA ezixegise imikhawulo yephilisi, okuhlanganisa. ukususa imfuneko ukuthi abesifazane bayicoshe mathupha.
Abameli be-FDA baveze ukuthi imiphumela emibi kakhulu nge-mifepristone ayivamile, futhi i-ejensi ikuqinisekisile kaningi ukuphepha komuthi ngokubuyekeza izifundo nedatha eyalandela. Ukudonsa umuthi eminyakeni engaphezu kwengu-20 ngemva kokugunyazwa kuyoba “okungavamile futhi okungakaze kubonwe ngaphambili,” kusho uhulumeni empendulweni yakhe engokomthetho.