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		<title>Judge halts FDA approval of abortion pill mifepristone but delays order to give time to feds to appeal</title>
		<link>https://cincylink.com/2023/05/29/judge-halts-fda-approval-of-abortion-pill-mifepristone-but-delays-order-to-give-time-to-feds-to-appeal/</link>
					<comments>https://cincylink.com/2023/05/29/judge-halts-fda-approval-of-abortion-pill-mifepristone-but-delays-order-to-give-time-to-feds-to-appeal/#respond</comments>
		
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		<pubDate>Mon, 29 May 2023 12:10:40 +0000</pubDate>
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					<description><![CDATA[A federal judge in Texas on Friday ordered a hold on U.S. approval of the abortion medication mifepristone, throwing into question access to the nation’s most common method of abortion in a ruling that waved aside decades of scientific approval.The immediate impact of the ruling by U.S. District Judge Matthew J. Kacsmaryk, which does not &#8230;]]></description>
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<p>
					A federal judge in Texas on Friday ordered a hold on U.S. approval of the abortion medication mifepristone, throwing into question access to the nation’s most common method of abortion in a ruling that waved aside decades of scientific approval.The immediate impact of the ruling by U.S. District Judge Matthew J. Kacsmaryk, which does not go into immediate effect, was unclear.The abortion drug has been widely used in the U.S. since 2000 and there is essentially no precedent for a lone judge overruling the medical decisions of the Food and Drug Administration. Mifepristone is one of two drugs used for medication abortion in the United States, along with misoprostol, which is also used to treat other medical conditions.Kacsmaryk, a Trump administration appointee in Amarillo, Texas, signed an injunction directing the FDA to stay mifepristone’s approval while a lawsuit challenging the safety and approval of the drug continues. His 67-page order gave the government seven days to appeal.“Simply put, FDA stonewalled judicial review — until now,” Kacsmaryk wrote.He didn’t go as far as the plaintiffs wanted by withdrawing or suspending the approval of the chemical abortion drug and removing it from the list of approved drugs. But he put a “stay” or hold on approval of the drug.Federal lawyers representing the FDA are expected to swiftly appeal.Clinics and doctors that prescribe the two-drug combination have said that if mifepristone were pulled from the market, they would switch to using only the second drug, misoprostol. That single-drug approach has a slightly lower rate of effectiveness in ending pregnancies, but it is widely used in countries where mifepristone is illegal or unavailable.Mifepristone is part of a two-drug regimen that has long been the standard for medication abortion in the U.S. Clinics and doctors that prescribe the combination say they plan to switch to using only misoprostol. The single-drug approach is slightly less effective at ending pregnancies.The lawsuit was filed by the Alliance Defending Freedom, which was also involved in the Mississippi case that led to Roe v. Wade being overturned. At the core of the lawsuit is the allegation that the FDA’s initial approval of mifepristone was flawed because it did not adequately review its safety risks.Courts have long deferred to the FDA on issues of drug safety and effectiveness. But the agency’s authority faces new challenges in a post-Roe legal environment in which abortions are banned or unavailable in 14 states, while 16 states have laws specifically targeting abortion medications.
				</p>
<div>
<p>A federal judge in Texas on Friday ordered a hold on U.S. approval of the abortion medication mifepristone, throwing into question access to the nation’s most common method of abortion in a ruling that waved aside decades of scientific approval.</p>
<p>The immediate impact of the ruling by U.S. District Judge Matthew J. Kacsmaryk, which does not go into immediate effect, was unclear.</p>
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<p>The abortion drug has been widely used in the U.S. since 2000 and there is essentially no precedent for a lone judge overruling the medical decisions of the Food and Drug Administration. Mifepristone is one of two drugs used for medication abortion in the United States, along with misoprostol, which is also used to treat other medical conditions.</p>
<p>Kacsmaryk, a Trump administration appointee in Amarillo, Texas, signed an injunction directing the FDA to stay mifepristone’s approval while a lawsuit challenging the safety and approval of the drug continues. His 67-page order gave the government seven days to appeal.</p>
<p>“Simply put, FDA stonewalled judicial review — until now,” Kacsmaryk wrote.</p>
<p>He didn’t go as far as the plaintiffs wanted by withdrawing or suspending the approval of the chemical abortion drug and removing it from the list of approved drugs. But he put a “stay” or hold on approval of the drug.</p>
<p>Federal lawyers representing the FDA are expected to swiftly appeal.</p>
<p>Clinics and doctors that prescribe the two-drug combination have said that if mifepristone were pulled from the market, they would switch to using only the second drug, misoprostol. That single-drug approach has a slightly lower rate of effectiveness in ending pregnancies, but it is widely used in countries where mifepristone is illegal or unavailable.</p>
<p>Mifepristone is part of a two-drug regimen that has long been the standard for medication abortion in the U.S. Clinics and doctors that prescribe the combination say they plan to switch to using only misoprostol. The single-drug approach is slightly less effective at ending pregnancies.</p>
<p>The lawsuit was filed by the Alliance Defending Freedom, which was also involved in the Mississippi case that led to Roe v. Wade being overturned. At the core of the lawsuit is the allegation that the FDA’s initial approval of mifepristone was flawed because it did not adequately review its safety risks.</p>
<p>Courts have long deferred to the FDA on issues of drug safety and effectiveness. But the agency’s authority faces new challenges in a post-Roe legal environment in which abortions are banned or unavailable in 14 states, while 16 states have laws specifically targeting abortion medications. </p>
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		<title>Supreme Court set to rule on abortion pill restrictions</title>
		<link>https://cincylink.com/2023/05/27/supreme-court-set-to-rule-on-abortion-pill-restrictions/</link>
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		<pubDate>Sat, 27 May 2023 04:21:16 +0000</pubDate>
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					<description><![CDATA[The Supreme Court is deciding whether women will face restrictions in getting a drug used in the most common method of abortion in the United States, while a lawsuit continues.Video above: Get the Facts: 1873 Comstock Act Used in Abortion Pill DecisionThe justices are expected to issue an order on Wednesday in a fast-moving case &#8230;]]></description>
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<p>
					The Supreme Court is deciding whether women will face restrictions in getting a drug used in the most common method of abortion in the United States, while a lawsuit continues.Video above: Get the Facts: 1873 Comstock Act Used in Abortion Pill DecisionThe justices are expected to issue an order on Wednesday in a fast-moving case from Texas in which abortion opponents are seeking to roll back Food and Drug Administration approval of the drug, mifepristone.The drug first won FDA approval in 2000, and conditions on its use have been loosened in recent years, including making it available by mail in states that allow access.The Biden administration and New York-based Danco Laboratories, the maker of the drug, want the nation’s highest court to reject limits on mifepristone’s use imposed by lower courts, at least as long as the legal case makes it way through the courts. They say women who want the drug and providers who dispense it will face chaos if limits on the drug take effect. Depending on what the justices decide, that could include requiring women to take a higher dosage of the drug than the FDA says is necessary.Alliance Defending Freedom, representing anti-abortion doctors and medical groups in a challenge to the drug, is defending the rulings in calling on the Supreme Court to let the restrictions take effect now.Video below: Doctor explains how medical abortion drug mifepristone worksThe legal fight over abortion comes less than a year after conservative justices reversed Roe v. Wade and allowed more than a dozen states to effectively ban abortion outright.Even as the abortion landscape changed dramatically in several states, abortion opponents set their sights on medication abortions, which make up more than half of all abortions in the United States.The abortion opponents filed suit in November in Amarillo, Texas. The legal challenge quickly reached the Supreme Court after a federal judge issued a ruling on April 7 that would revoke FDA approval of mifepristone, one of two drugs used in medication abortions.Less than a week later, a federal appeals court modified the ruling so that mifepristone would remain available while the case continues, but with limits. The appeals court said that the drug can’t be mailed or dispensed as a generic and that patients who seek it need to make three in-person visits with a doctor, among other things.Video below: Ex-FDA commissioner on mifepristone rulingThe generic version of mifepristone makes up two-thirds of the supply in the United States, its manufacturer, Las Vegas-based GenBioPro Inc., wrote in a court filing that underscored the perils of allowing the restrictions to be put into effect. The court also said the drug should only be approved through seven weeks of pregnancy for now, even though the FDA since 2016 has endorsed its use through 10 weeks of pregnancy.Complicating the situation, a federal judge in Washington has ordered the FDA to preserve access to mifepristone under the current rules in 17 Democratic-led states and the District of Columbia that filed a separate lawsuit. The Biden administration has said the rulings conflict and create an untenable situation for the FDA.In an order issued last Friday by Justice Samuel Alito, the court put the restrictions on hold through Wednesday to give the court time to consider the emergency appeal. If the justices aren't inclined to block the ruling from taking effect for now, the Democratic administration and Danco have a fallback argument, asking the court to take up the challenge to mifepristone, hear arguments and decide the case by early summer.The court only rarely takes such a step before at least one appeals court has thoroughly examined the legal issues involved.The 5th U.S. Circuit Court of Appeals in New Orleans already has ordered an accelerated schedule for hearing the case, with arguments set for May 17.Mifepristone has been available for use in medication abortions in the United States since the FDA granted approval in 2000. Since then, more than 5 million women have used it, along with another drug, misoprostol, to induce abortions.
				</p>
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					<strong class="dateline">WASHINGTON —</strong> 											</p>
<p>The Supreme Court is deciding whether women will face restrictions in getting a drug used in the most common method of abortion in the United States, while a lawsuit continues.</p>
<p><strong><em>Video above: Get the Facts: 1873 Comstock Act Used in Abortion Pill Decision</em></strong></p>
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<p>The justices are expected to issue an order on Wednesday in a fast-moving case from Texas in which abortion opponents are seeking to roll back Food and Drug Administration approval of the drug, mifepristone.</p>
<p>The drug first won FDA approval in 2000, and conditions on its use have been loosened in recent years, including making it available by mail in states that allow access.</p>
<p>The Biden administration and New York-based Danco Laboratories, the maker of the drug, want the nation’s highest court to reject limits on mifepristone’s use imposed by lower courts, at least as long as the legal case makes it way through the courts. They say women who want the drug and providers who dispense it will face chaos if limits on the drug take effect. Depending on what the justices decide, that could include requiring women to take a higher dosage of the drug than the FDA says is necessary.</p>
<p>Alliance Defending Freedom, representing anti-abortion doctors and medical groups in a challenge to the drug, is defending the rulings in calling on the Supreme Court to let the restrictions take effect now.</p>
<p><strong><em>Video below: Doctor explains how medical abortion drug mifepristone works</em></strong></p>
<p>The legal fight over abortion comes less than a year after conservative justices reversed Roe v. Wade and allowed more than a dozen states to effectively ban abortion outright.</p>
<p>Even as the abortion landscape changed dramatically in several states, abortion opponents set their sights on medication abortions, which make up more than half of all abortions in the United States.</p>
<p>The abortion opponents filed suit in November in Amarillo, Texas. The legal challenge quickly reached the Supreme Court after a federal judge issued a ruling on April 7 that would revoke FDA approval of mifepristone, one of two drugs used in medication abortions.</p>
<p>Less than a week later, a federal appeals court modified the ruling so that mifepristone would remain available while the case continues, but with limits. The appeals court said that the drug can’t be mailed or dispensed as a generic and that patients who seek it need to make three in-person visits with a doctor, among other things.</p>
<p><strong><em>Video below: Ex-FDA commissioner on mifepristone ruling</em></strong></p>
<p>The generic version of mifepristone makes up two-thirds of the supply in the United States, its manufacturer, Las Vegas-based GenBioPro Inc., wrote in a court filing that underscored the perils of allowing the restrictions to be put into effect. </p>
<p>The court also said the drug should only be approved through seven weeks of pregnancy for now, even though the FDA since 2016 has endorsed its use through 10 weeks of pregnancy.</p>
<p>Complicating the situation, a federal judge in Washington has ordered the FDA to preserve access to mifepristone under the current rules in 17 Democratic-led states and the District of Columbia that filed a separate lawsuit. </p>
<p>The Biden administration has said the rulings conflict and create an untenable situation for the FDA.</p>
<p>In an order issued last Friday by Justice Samuel Alito, the court put the restrictions on hold through Wednesday to give the court time to consider the emergency appeal. </p>
<p>If the justices aren't inclined to block the ruling from taking effect for now, the Democratic administration and Danco have a fallback argument, asking the court to take up the challenge to mifepristone, hear arguments and decide the case by early summer.</p>
<p>The court only rarely takes such a step before at least one appeals court has thoroughly examined the legal issues involved.</p>
<p>The 5th U.S. Circuit Court of Appeals in New Orleans already has ordered an accelerated schedule for hearing the case, with arguments set for May 17.</p>
<p>Mifepristone has been available for use in medication abortions in the United States since the FDA granted approval in 2000. Since then, more than 5 million women have used it, along with another drug, misoprostol, to induce abortions.</p>
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		<title>A look at abortion debates this week in US courts, statehouses</title>
		<link>https://cincylink.com/2023/05/25/a-look-at-abortion-debates-this-week-in-us-courts-statehouses/</link>
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		<pubDate>Thu, 25 May 2023 04:10:15 +0000</pubDate>
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					<description><![CDATA[Lawmakers in South Carolina passed an abortion ban while a judge in Montana was weighing restrictions there in the latest developments in the shifting landscape of law since the U.S. Supreme Court last year overturned Roe v. Wade and the nationwide right to abortion.Here's what to know.BACK TO THE SENATE IN SOUTH CAROLINAIn conservative South &#8230;]]></description>
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<p>
					Lawmakers in South Carolina passed an abortion ban while a judge in Montana was weighing restrictions there in the latest developments in the shifting landscape of law since the U.S. Supreme Court last year overturned Roe v. Wade and the nationwide right to abortion.Here's what to know.BACK TO THE SENATE IN SOUTH CAROLINAIn conservative South Carolina, Republicans have been butting heads — sometimes dramatically — on how far to go with abortion bans.The state Senate on Tuesday passed the latest effort to impose a ban on abortion after about six weeks of pregnancy, before many women know they're pregnant. The vote sent the bill to the governor, who has promised to sign it.The three Republican women in the Senate joined all Democrats in voting against the bill. The House approved the ban last week, after an earlier effort narrowly fell short on procedural votes.Lawmakers in conservative-dominated Nebraska have taken a similar path, with intraparty disputes until a 12-week ban was passed last week as part of a bill that would also ban gender-affirming care for those under 19. Republican Gov. Jim Pillen signed the bill Monday, and the abortion restrictions took effect immediately.COURTS STEP IN AGAIN IN MONTANAMontana Republican Gov. Greg Gianforte signed a ban last week on dilation and evacuation abortions, which are normally performed in the second trimester of pregnancy. Within days, a judge temporarily blocked enforcement of the ban. On Tuesday, the judge issued a preliminary injunction, which blocks the law while the case moves its way through the courts.The judge on Tuesday also granted to preliminary injunctions to one rule and several other laws.   The rule and one of the laws require prior authorization before Montana's Medicaid will pay for abortions. Another law says public funds cannot be used to pay for most abortions. And another requires an ultrasound before performing an abortion, which opponents say effectively blocks telehealth medication abortions in the state.Those are not the only abortion restrictions in the state before the courts.Montana in 2021 adopted a broader ban on abortions after 20 weeks of pregnancy, but the state Supreme Court ruled that it will not enforce it pending a court challenge. That left some abortions legal until viability, around the 24th week.GROUPS REACT TO SHIFTING TERRAINPlanned Parenthood and Susan B. Anthony Pro-Life America, groups on opposite sides of the abortion policy debates, both announced initiatives Tuesday.The national Planned Parenthood group, a federation of regional organizations that share the name and provide abortion care, sexually transmitted infection tests, cancer screenings and other health services, announced a strategy shift. It is laying off 10% to 15% of its national staff and sending more money to its affiliates. The plan is to improve health equity for Black people and to bolster services both in states with bans and those that are serving more abortion-seeking patients traveling from places with bans.The group's political arm also expects to focus on state politics.Susan B. Anthony, a major opponent of abortion, announced it's working with Kellyanne Conway, a former adviser to President Donald Trump, to "get pro-life candidates on offense in the 2024 election cycle."Last year, abortion access advocates prevailed on all six abortion-related statewide ballot initiatives in the U.S.PURPLE STATE POLICYSince the Supreme Court's Dobbs ruling, tighter abortion restrictions have been enacted in most Republican-controlled states and protections of abortion access have gone into effect in most that are dominated by Democrats.In the 11 states where government control is divided between Republicans and Democrats, the story has not been so uniform. Virginia has kept its status quo, for instance, while Vermont has adopted a constitutional amendment to preserve abortion access and Louisiana and Kentucky have bans in place.Video below: North Carolina GOP overrides veto of 12-week abortion limitChange came quickly in North Carolina in April when one state lawmaker flipped from Democrat to Republican, giving the GOP enough votes to override gubernatorial vetoes.Lawmakers promptly passed a ban that's less restrictive than most — allowing abortion for the first 12 weeks of pregnancy. Democratic Gov. Roy Cooper vetoed it. But lawmakers on May 16 overrode that veto, so the ban will take effect July 1. The new law includes several other provisions that medical experts have criticized, including more medical and paperwork requirements for physicians, new licensing requirements for abortion clinics and increasing how many times patients must make an in-person visit to a physician ahead of obtaining the abortion pill.COURT ARGUMENTS ON AN ABORTION PILLMost of the legal battles on abortion since the Dobbs decision in 2022 have centered on whether individual state constitutions protect the right to abortion.But at least one lawsuit has implications nationally.An anti-abortion group sued seeking to rescind the U.S. Food and Drug Administration's 2000 approval of mifepristone, one of two drugs used in combination in most medication-induced abortions in the U.S.A federal judge in Texas agreed. The New Orleans-based 5th U.S. Circuit Court of Appeals heard arguments last week. In the meantime, the U.S. Supreme Court has said that mifepristone can remain on the market. It is already barred from being used in abortions, with some exceptions, in states with bans in place.It's not clear when the appeals court will rule. The case is expected to return to the nation's top court eventually. The Texas-based case could be merged with one in Washington, where another federal judge ruled last month that mifepristone restrictions cannot be rolled back in a group of Democrat-led states that filed lawsuits.THE TALLYFourteen states currently have bans on abortion at all stages of pregnancy, one when cardiac activity can be detected around six weeks, and three at 12 to 15 weeks. Of those 17 states with the tightest restrictions, 12 do not have exceptions in cases of rape or incest. They all have exceptions to save the life of the woman in at least some circumstances.Video below: Nebraska's governor signed abortions and transgender youth restrictions into lawAt least six states have bans that courts have paused.One more state, North Carolina, has a ban after 12 weeks of pregnancy that doesn't take effect until July 1.The abortion bans also apply to prescribing pills to induce abortions. But only in South Carolina and Texas is it illegal to self-manage abortions.
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<div>
<p>Lawmakers in South Carolina passed an abortion ban while a judge in Montana was weighing restrictions there in the latest developments in the shifting landscape of law since the U.S. Supreme Court last year overturned Roe v. Wade and the nationwide right to abortion.</p>
<p>Here's what to know.</p>
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<h2 class="body-h2">BACK TO THE SENATE IN SOUTH CAROLINA</h2>
<p>In conservative South Carolina, Republicans have been butting heads — sometimes dramatically — on how far to go with abortion bans.</p>
<p>The state Senate on Tuesday passed the latest effort to impose a ban on abortion after about six weeks of pregnancy, before many women know they're pregnant. The vote sent the bill to the governor, who has promised to sign it.</p>
<p>The three Republican women in the Senate joined all Democrats in voting against the bill. The House approved the ban last week, after an earlier effort narrowly fell short on procedural votes.</p>
<p>Lawmakers in conservative-dominated Nebraska have taken a similar path, with intraparty disputes until a 12-week ban was passed last week as part of a bill that would also ban gender-affirming care for those under 19. Republican Gov. Jim Pillen signed the bill Monday, and the abortion restrictions took effect immediately.</p>
<h2 class="body-h2">COURTS STEP IN AGAIN IN MONTANA</h2>
<p>Montana Republican Gov. Greg Gianforte signed a ban last week on dilation and evacuation abortions, which are normally performed in the second trimester of pregnancy. Within days, a judge temporarily blocked enforcement of the ban. On Tuesday, the judge issued a preliminary injunction, which blocks the law while the case moves its way through the courts.</p>
<p>The judge on Tuesday also granted to preliminary injunctions to one rule and several other laws.   </p>
<p>The rule and one of the laws require prior authorization before Montana's Medicaid will pay for abortions. Another law says public funds cannot be used to pay for most abortions. And another requires an ultrasound before performing an abortion, which opponents say effectively blocks telehealth medication abortions in the state.</p>
<p>Those are not the only abortion restrictions in the state before the courts.</p>
<p>Montana in 2021 adopted a broader ban on abortions after 20 weeks of pregnancy, but the state Supreme Court ruled that it will not enforce it pending a court challenge. That left some abortions legal until viability, around the 24th week.</p>
<h2 class="body-h2">GROUPS REACT TO SHIFTING TERRAIN</h2>
<p>Planned Parenthood and Susan B. Anthony Pro-Life America, groups on opposite sides of the abortion policy debates, both announced initiatives Tuesday.</p>
<p>The national Planned Parenthood group, a federation of regional organizations that share the name and provide abortion care, sexually transmitted infection tests, cancer screenings and other health services, announced a strategy shift. It is laying off 10% to 15% of its national staff and sending more money to its affiliates. The plan is to improve health equity for Black people and to bolster services both in states with bans and those that are serving more abortion-seeking patients traveling from places with bans.</p>
<p>The group's political arm also expects to focus on state politics.</p>
<p>Susan B. Anthony, a major opponent of abortion, announced it's working with Kellyanne Conway, a former adviser to President Donald Trump, to "get pro-life candidates on offense in the 2024 election cycle."</p>
<p>Last year, abortion access advocates prevailed on all six abortion-related statewide ballot initiatives in the U.S.</p>
<h2 class="body-h2">PURPLE STATE POLICY</h2>
<p>Since the Supreme Court's Dobbs ruling, tighter abortion restrictions have been enacted in most Republican-controlled states and protections of abortion access have gone into effect in most that are dominated by Democrats.</p>
<p>In the 11 states where government control is divided between Republicans and Democrats, the story has not been so uniform. Virginia has kept its status quo, for instance, while Vermont has adopted a constitutional amendment to preserve abortion access and Louisiana and Kentucky have bans in place.</p>
<p><strong><em>Video below: North Carolina GOP overrides veto of 12-week abortion limit</em></strong></p>
<p>Change came quickly in North Carolina in April when one state lawmaker flipped from Democrat to Republican, giving the GOP enough votes to override gubernatorial vetoes.</p>
<p>Lawmakers promptly passed a ban that's less restrictive than most — allowing abortion for the first 12 weeks of pregnancy. Democratic Gov. Roy Cooper vetoed it. But lawmakers on May 16 overrode that veto, so the ban will take effect July 1. </p>
<p>The new law includes several other provisions that medical experts have criticized, including more medical and paperwork requirements for physicians, new licensing requirements for abortion clinics and increasing how many times patients must make an in-person visit to a physician ahead of obtaining the abortion pill.</p>
<h2 class="body-h2">COURT ARGUMENTS ON AN ABORTION PILL</h2>
<p>Most of the legal battles on abortion since the Dobbs decision in 2022 have centered on whether individual state constitutions protect the right to abortion.</p>
<p>But at least one lawsuit has implications nationally.</p>
<p>An anti-abortion group sued seeking to rescind the U.S. Food and Drug Administration's 2000 approval of mifepristone, one of two drugs used in combination in most medication-induced abortions in the U.S.</p>
<p>A federal judge in Texas agreed. The New Orleans-based 5th U.S. Circuit Court of Appeals heard arguments last week. In the meantime, the U.S. Supreme Court has said that mifepristone can remain on the market. It is already barred from being used in abortions, with some exceptions, in states with bans in place.</p>
<p>It's not clear when the appeals court will rule. The case is expected to return to the nation's top court eventually. The Texas-based case could be merged with one in Washington, where another federal judge ruled last month that mifepristone restrictions cannot be rolled back in a group of Democrat-led states that filed lawsuits.</p>
<h2 class="body-h2">THE TALLY</h2>
<p>Fourteen states currently have bans on abortion at all stages of pregnancy, one when cardiac activity can be detected around six weeks, and three at 12 to 15 weeks. Of those 17 states with the tightest restrictions, 12 do not have exceptions in cases of rape or incest. They all have exceptions to save the life of the woman in at least some circumstances.</p>
<p><strong><em>Video below: Nebraska's governor signed abortions and transgender youth restrictions into law</em></strong></p>
<p>At least six states have bans that courts have paused.</p>
<p>One more state, North Carolina, has a ban after 12 weeks of pregnancy that doesn't take effect until July 1.</p>
<p>The abortion bans also apply to prescribing pills to induce abortions. But only in South Carolina and Texas is it illegal to self-manage abortions.</p>
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