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Pills of Misoprostol, used to terminate early pregnancies, are displayed in a pharmacy in Provo, Utah, May 12, 2022. New York and California are stockpiling massive quantities of an alternative abortion medication in case a federal judge's order suspending the Food and Drug Administration's approval of the main drug mifepristone goes into effect later this week. Kathy Hochul on Tuesday ordered the state health department to immediately start purchasing 150,000 doses of misoprostol, a five-year supply of the pill. Gavin Newsom said California has secured 2 million pills of misoprostol. The second pill is used as a standalone abortion medication in parts of the world.
A Texas judge on Friday issued a ruling overturning FDA approval of an abortion medication. The 67-page document, written by right-wing Judge Matthew Kacsmaryk, cited Wikipedia and is full of inaccuracies and falsehoods about the health effects of medical abortion, experts told Insider on Friday. Julia Steinberg, an expert on mental health and abortion, told Reuters in 2012 that most women in the study who experienced mental health issues after having an abortion had also experienced them before the abortion. The study also did not note whether or not the abortions had been done for health reasons or were elective abortions. So he is really outside of his lane making, in essence, a medical judgment that was informed by really, really bad information."
CNN —Dueling decisions in two federal district courts last week are likely to set up a showdown at the Supreme Court over the fate of the abortion pill mifepristone. When the Supreme Court upheld the federal Partial-Birth Abortion Ban Act in 2007, dubious scientific arguments became even more central to anti-abortion advocacy. In Gonzales v. Carhart, the court held that in circumstances of scientific uncertainty, legislators would have more latitude to regulate abortion. Implausible scientific claims are now visible on social media, in lawsuits and in congressional hearings. (By taking this position, abortion opponents can still defend bans with no or few exceptions by claiming that abortion is never necessary.)
Attorneys general for nearly half of U.S. states in a new court filing warn that a federal judge's decision to suspend the Food and Drug Administration's 23-year-old approval of mifepristone across the country "presents devastating risks to millions of people," including those in states where abortion remains legal. The attorneys general in their filing Monday called on the U.S. 5th Circuit Court of Appeals to keep mifepristone on the market as litigation over the legality of the pill plays out. Judge Matthew Kacsmaryk of U.S. District Court in Amarillo, Texas, on Friday effectively revoked the FDA approval of mifepristone. The Department of Justice on Monday asked the 5th Circuit to rule on its request to halt Kacsmaryk's decision by noon Thursday "to enable the government to seek relief in the Supreme Court if necessary." Danco Laboratories, the distributor of mifepristone, also has asked the appeals court to pause Kacsmaryk's decision for at least 14 days so the company has the opportunity to "seek emergency relief from the Supreme Court."
A federal judge's ruling could take the abortion pill mifepristone off the market — but there is another medication that could provide an alternative for people seeking to terminate their pregnancies. Two states in reaction to that ruling already are stockpiling supplies of misoprostol, the drug that doctors typically prescribe with mifepristone to induce an abortion. That leaves misoprostol available as a safe and effective treatment for women who want to end their pregnancies. Some U.S. abortion providers are prepared to offer misoprostol as a stand-alone treatment, according to Jenny Ma, senior staff attorney at the Center for Reproductive Rights, a legal advocacy group that represents abortion providers worldwide. A study released in February by abortion researchers at the University of Texas in Austin found that misoprostol was 88% effective at causing an abortion.
[1/4] A pack of birth control pills is displayed in this illustration picture taken in Philadelphia, Pennsylvania, U.S., July 11, 2022. REUTERS/Hannah Beier/IllustrationApril 10 (Reuters) - Over 300 biotech and pharmaceutical industry executives, including Pfizer Inc (PFE.N) CEO Albert Bourla, signed an open letter on Monday calling for reversal of a federal judge's decision to suspend sales of the abortion pill mifepristone. Last week's ruling by Judge Matthew Kacsmaryk undermines the FDA's authority, the letter's authors wrote, adding that it ignores decades of scientific evidence and legal precedent. The ruling could open the possibility to the banning of vaccines and contraception for women, said Levin. "It's the single worst threat to the industry in over 50 years."
Democrats for Defying Court Orders
  + stars: | 2023-04-10 | by ( The Editorial Board | ) www.wsj.com   time to read: 1 min
One depressing sign of the political times is that partisans on the left and right are willing to trash political norms and institutions to get their way. The latest example comes from Democrats urging the Biden Administration to ignore last week’s federal court order concerning the abortion drug mifepristone. His national injunction is also excessive before the merits are even considered. But the judge delayed the enforcement of his order for a week to give the Biden Administration time to appeal. The Fifth Circuit Court of Appeals will weigh in on the national injunction and the legal merits of the case.
Abortion-Pill Ruling Draws Muted Response From GOP
  + stars: | 2023-04-10 | by ( Michelle Hackman | ) www.wsj.com   time to read: 1 min
Former Vice President Mike Pence was one of a few Republicans to publicly comment on the decision. Republican lawmakers’ muted reaction to a federal judge’s ruling to suspend access to the abortion pill is the latest sign that the GOP’s legal success in limiting access to abortions is causing the party political headaches. Friday’s ruling, issued by U.S. District Judge Matthew Kacsmaryk, suspends the Food and Drug Administration’s approval of the pill, known as mifepristone, which is now used in a majority of abortions in the U.S. The judge, a Trump appointee who sits in Amarillo, Texas, delayed the impact of his decision for a week while the Biden administration appeals.
The Justice Department filed an emergency motion seeking a stay on last week's abortion pill ruling. Anti-abortion activists lacked standing to challenge FDA approval of the drug, the department says. But anti-abortion doctors are neither in a position to use nor prescribe mifepristone, the DOJ said. Feds criticize anti-abortion studyIn their filing, Justice Department lawyers also took aim at the sources Judge Kacsmaryk cited to justify his decision. The Justice Department, in turn, described the source as "an article" that was "based entirely on fewer than 100 anonymous blog posts submitted to a website titled 'Abortion Changes You.'"
WASHINGTON, April 10 (Reuters) - A federal judge's decision last week to suspend the U.S. Food and Drug Administration's (FDA) approval of abortion pill mifepristone could severely weaken the agency if allowed to stand, health policy and legal experts said. The FDA approved mifepristone, part of a two-drug regimen that accounts for more than half of U.S. abortions, over 20 years ago. Banning its sale calls into question the FDA's power to regulate all drugs nationwide, the experts said. The challenge was brought by a coalition of anti-abortion groups and doctors seeking withdrawal of the FDA's mifepristone approval before Kacsmaryk, who is himself a conservative former Christian activist. Plaintiffs are arguing that the FDA in its 2000 approval did not adequately consider the drug's safety when used by girls under age 18 to terminate a pregnancy.
Boxes of mifepristone, the first pill given in a medical abortion, are prepared for patients at Women's Reproductive Clinic of New Mexico in Santa Teresa, U.S., January 13, 2023. The DOJ asked the U.S. 5th Circuit Court of Appeals to block U.S. Judge Matthew Kacsmaryk's unprecedented decision by noon Thursday "to enable the government to seek relief in the Supreme Court if necessary." Kacsmaryk's suspension of the FDA's approval of mifepristone is set to take effect on Friday. "If allowed to take effect, that order will irreparably harm patients, healthcare systems, and businesses," the Justice Department lawyers wrote in a court filing. When asked whether Danco will stop distributing mifepristone if Kacsmaryk's decision takes effect this Friday, Ellsworth said the company will consult with the FDA about how to proceed.
Pfizer 's CEO signed on to an industry letter in support of the Food and Drug Administration's authority to regulate drugs after a federal judge in Texas suspended the agency's approval of the abortion pill mifepristone. Albert Bourla was among the more than 200 pharmaceutical company executives who signed the letter after U.S. Judge Matthew Kacsmaryk's controversial ruling on Friday. Kacsmaryk sided with an anti-abortion group, arguing that the FDA rushed its approval process and violated federal standards. Kacsmaryk's decision conflicts with a ruling by a federal judge in Washington state. The dueling orders by two federal judges create a complicated legal standoff that could potentially escalate to the Supreme Court.
Rice's decision came just 20 minutes after U.S. District Judge Matthew Kacsmaryk of the U.S. Northern District of Texas suspended the FDA's approval of mifepristone nationwide. The Justice Department on Monday asked the 5th Circuit Court of Appeals to block Kacsmaryk's decision from taking effect as litigation plays out. The government's lawyers indicated they may ask the Supreme Court to get involved. The Justice Department asked Rice to clarify its obligations on the legality of mifepristone by Friday. Kacsmaryk's decision goes into effect at midnight CT on Saturday if the 5th Circuit doesn't block the order out of Texas.
Kacsmaryk, an appointee of Republican former President Donald Trump, stayed his ruling for seven days to allow the Biden administration time to appeal. The Justice Department asked that a stay be entered by April 13, and that it remain in place until all appeals, including if necessary to the Supreme Court, are resolved. Lawyers for the anti-abortion groups that challenged the FDA's approval of mifepristone did not immediately respond to requests for comment. The conflicting rulings could foreshadow a resolution by the Supreme Court, which last June overturned the 1973 Roe v. Wade decision that eliminated a constitutional right to abortion. The Supreme Court has a 6-3 conservative majority.
"We are discussing ways to offer them legal support," one of the sources said of manufacturers and retail pharmacies. Major U.S. manufacturers of abortion pills include GenBioPro Inc and Danco Laboratories. Walgreens said in March it would not dispense abortion pills in the 20 states where it risked breaking the law. Discussions between the Biden administration and pill manufacturers and pharmacies over the issue have been ongoing for months, sources said, but Friday's decision brings fresh urgency. It is unclear whether the administration is considering following in California Governor Gavin Newsom's footsteps by withholding federal contracts from chains that suspend abortion pill sales.
Texas Abortion-Pill Ruling Ignites New National Battle
  + stars: | 2023-04-09 | by ( Laura Kusisto | ) www.wsj.com   time to read: 1 min
Photo: Michael Noble Jr. for The Wall Street JournalMifepristone is sold under the brand name Mifeprex and in a generic version. A ruling by a Texas judge suspending approval of the abortion pill sets off a new national fight over women’s access to abortion less than a year after the Supreme Court withdrew constitutional protections for the procedure. In a 67-page ruling on Friday, U.S. District Judge Matthew Kacsmaryk, a Trump appointee who sits in Amarillo, said the U.S. Food and Drug Administration made a series of legal errors in approving the pill, known as mifepristone, for sale. He delayed the impact of his decision for a week while the Biden administration appeals and seeks an emergency stay.
April 7 (Reuters) - The federal judge who on Friday suspended approval of the abortion pill mifepristone is a former Christian legal activist whose small courthouse in Amarillo, Texas, has become a go-to destination for conservatives challenging Biden administration policies. U.S. District Judge Matthew Kacsmaryk, an appointee of former Republican President Donald Trump, had a long track record of opposing abortion and LGBTQ rights before the U.S. Senate confirmed him in 2019 to a life-tenured position as a federal judge. FAVORED VENUESince then, his courthouse has become a favored venue for conservative legal activists and Republican state attorneys general pursuing lawsuits seeking to halt aspects of Democratic President Joe Biden's agenda - often with success. In October, Kacsmaryk vacated Biden administration guidance requiring employers to allow transgender workers to dress and use bathrooms consistent with their gender identities. Reporting by Nate Raymond in Boston, Editing by Alexia Garamfalvi, Bill Berkrot and Diane CraftOur Standards: The Thomson Reuters Trust Principles.
The Biden administration is seeking an emergency stay of Kacsmaryk's order from the New Orleans-based 5th U.S. The 5th Circuit has a conservative reputation, with 12 of its 16 active judges appointed by Republican presidents. The FDA could then petition the U.S. Supreme Court for an emergency stay. Regardless of whether it wins an emergency stay of the injunction, the FDA will continue its appeal of Kacsmaryk's preliminary injunction. Once it does come, the losing side will again have the chance to appeal to the 5th Circuit and, eventually, the Supreme Court.
"So many of the things in this ruling I would say are completely flawed," a researcher told Insider. But an OB-GYN told Insider the judge's interpretation of what the drug does is medically inaccurate. Mifepristone and misoprostol are used before we can even see an embryo on ultrasound," Grossman told Insider. Spreading such misinformation through an official judicial ruling, Biggs said, is "inappropriate, unethical, and jarring." It's definitely not going to help or prevent mental health harm or physical harm as it claims – it's going to do the opposite."
Dueling court rulings on the abortion pill mifepristone have further ignited passions on the issue. Ipsos polling reveals that Americans don't want to see an end to the legality of medication abortion. And the level of support for the continued legalization of medication abortion in the United States remains high. The Ipsos survey revealed that 65% of respondents wanted to see medication abortion remain available as an option, with 84% support among Democrats and 67% support among Independents. DeSantis, who has thrown his support behind a six-week abortion ban also embraced by the Republican-controlled Florida legislature, may have the most at stake, though.
That gives the Biden administration time to appeal, and means the abortion pill is still available. The future legal status of the drug was also complicated by a contradictory ruling issued in Washington state also on Friday. However, the judge gave seven days before the ruling would take effect, giving the Biden administration time to appeal the decision and request emergency relief. For now, the drug is still legal and available in states in which it was legal and available prior to Friday's ruling. It's unclear what will happen next, but the Biden administration is very likely to appeal.
Pool via REUTERSApril 8 (Reuters) - The federal judge who on Friday suspended approval of the abortion pill mifepristone is a former Christian legal activist whose small courthouse in Amarillo, Texas, has become a go-to destination for conservatives challenging Biden administration policies. U.S. District Judge Matthew Kacsmaryk, an appointee of former Republican President Donald Trump, had a long track record of opposing abortion and LGBTQ rights before the U.S. Senate confirmed him in 2019 to a life-tenured position as a federal judge. When anti-abortion groups in November filed a lawsuit challenging the U.S. Food and Drug Administration's more than two-decade old approval of the abortion pill mifepristone, they filed in Amarillo, guaranteeing the case would be heard by Kacsmaryk. FAVORED VENUESince then, his courthouse has become a favored venue for conservative legal activists and Republican state attorneys general pursuing lawsuits seeking to halt aspects of Democratic President Joe Biden's agenda - often with success. While the district's chief judge could order cases be reallocated, he has not.
A federal judge on Friday suspended approval of the abortion pill, in a preliminary ruling against the Food and Drug Administration that could limit women’s access to the most common method for ending a pregnancy. U.S. District Judge Matthew Kacsmaryk of Amarillo, Texas, said in a 67-page ruling that the FDA made a series of legal errors in approving the pill for sale in the U.S. The judge suspended approval of the pill but delayed the impact of his decision for a week to give the Biden administration a chance to appeal.
Texas Judge Matthew Kacsmaryk issued a ruling Friday that jeopardizes the availability of a key abortion drug. An antiabortion legal group had sought to revoke or suspend the FDA's approval of the drug mifepristone. In the ruling, Judge Matthew Kacsmaryk, who was appointed by former President Donald Trump, imposed a stay on the Food & Drug Administration's approval of the drug, arguing that it was unlawful. Revoking the FDA's approval of mifepristone could immediately upend abortion access for countless women across the country. The medication mifepristone typically works as part of a two-medication regimen to terminate pregnancies.
Abortion rights advocates gather in front of the J Marvin Jones Federal Building and Courthouse in Amarillo, Texas, on March 15, 2023. A federal judge in Texas on Friday stayed the Food and Drug Administration's approval of the abortion pill mifepristone, but delayed the ruling taking effect for a week, giving the Biden administration time to appeal. The Food and Drug Administration, abortion pill maker Danco Laboratories and the anti-abortion group Alliance Defending Freedom presented their arguments before the court. The alliance represents a coalition of physicians opposed to abortion called the Alliance for Hippocratic Medicine, which sued the FDA in November over its approval of mifepristone. It took more than four years from the filing of the initial application until the pill was approved.
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