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☆ Supreme Court says abortion pill mifepristone will remain broadly available during legal battle
▼ + stars: | 2023-04-21 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

Demonstrators rally in support of abortion rights at the US Supreme Court in Washington, DC, April 15, 2023. The Supreme Court on Friday ordered the abortion pill mifepristone to remain broadly available as litigation plays out in a lower court. The appeals court has scheduled oral arguments for Wednesday, May 17 at 1 pm CT. Mifepristone has become the central flashpoint in the legal battle over abortion since the Supreme Court last summer overturned Roe v. Wade, the landmark 1973 decision that guaranteed abortion as a constitutional right nationwide. The appeals court judges also suspended the 2019 approval of the generic version of mifepristone.

The Supreme Court, which has a 6-3 conservative majority, is expected to act before the deadline to either grant or reject the requests or further pause the litigation. The Food and Drug Administration (FDA), the U.S. agency that signs off on the safety of food products, drugs and medical devices, approved mifepristone in 2000. Circuit Court of Appeals on April 12 declined to block the curbs ordered by Kacsmaryk. Anti-abortion groups led by the recently formed Alliance for Hippocratic Medicine and four anti-abortion doctors sued the FDA in November. The plaintiffs contend that the agency used an unlawful process to approve the drug, which they consider to be dangerous.

It is the second time in a year that the Supreme Court has considered a major effort to sharply curtail access to abortion. Less than an hour later, a federal judge in Washington State, Thomas O. The competing rulings meant that the matter was almost certainly headed to the Supreme Court. But the panel imposed several barriers to access, siding in part with Judge Kacsmaryk, while the lawsuit moved through the courts. Seeking emergency relief, the Biden administration asked the Supreme Court to intervene while a fast-tracked appeal moved forward.

☆ Opinion | The Abortion Pill Case Could Throw Our Health Care System Into Chaos
▼ + stars: | 2023-04-20 | by ( Jack Resneck Jr. | ) www.nytimes.com time to read: +2 min

Against this backdrop, the Supreme Court faces a decision that lays bare the threat to facts, evidence and the health of America’s patients. — in which anti-abortion organizations and doctors who have never prescribed the pill mifepristone argue, absurdly, that 23 years ago the F.D.A. If the lower courts’ rulings on mifepristone are not reversed entirely, it could also upend the Food and Drug Administration’s drug regulatory process. This would throw our health care system into chaos in ways that extend far beyond the specific fight over mifepristone, a highly effective drug that has been used safely by millions of patients for medication abortions and for miscarriage care for more than two decades. In seeking to restrict access to abortion across the United States, the plaintiffs in this case have, intentionally or not, seriously jeopardized our nation’s 85-year-old drug regulatory system.

HOW DID IT REACH THE SUPREME COURT? Whether or not the Supreme Court decides to stay Kacsmaryk's order, it will not decide the merits of the case. The Biden administration said in its petition to the Supreme Court that the FDA cannot comply with both orders. WHAT HAPPENS AFTER THE SUPREME COURT RULES? Once it does come, the losing side will again have the chance to appeal to the 5th Circuit and, eventually, the Supreme Court.

☆ Anti-abortion groups urge US Supreme Court to restrict abortion pill
▼ + stars: | 2023-04-18 | by ( Andrew Chung | ) www.reuters.com time to read: +4 min

WASHINGTON, April 18 (Reuters) - The U.S. Supreme Court should restrict the availability of the abortion pill mifepristone, anti-abortion groups challenging the medication's federal regulatory approval told the justices in a filing on Tuesday, urging them to implement curbs ordered by a conservative federal judge in Texas. Mifepristone is taken with another drug called misoprostol to perform medication abortion, which now accounts for more than half of all U.S. abortions. The Supreme Court has a 6-3 conservative majority. Anti-abortion groups led by the recently formed Alliance for Hippocratic Medicine and four anti-abortion doctors sued the FDA in November seeking to reverse approval of mifepristone. Since last year's Supreme Court decision, 12 U.S. states have put in place outright bans while many others prohibit abortion after a certain length of pregnancy.

☆ Anti-abortion group asks Supreme Court to keep mifepristone restrictions
▼ + stars: | 2023-04-18 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

Anti-abortion demonstrators celebrate outside the United States Supreme Court as the court rules in the Dobbs v Women's Health Organization abortion case, overturning the landmark Roe v Wade abortion decision in Washington, U.S., June 24, 2022. An anti-abortion group on Tuesday asked the Supreme Court to keep restrictions on the abortion pill mifepristone in place while the battle over the medication's legal status plays out. Supreme Court Justice Samuel Alito on Friday temporarily blocked those restrictions until 11:59 p.m. The anti-abortion organization also said the court should consider whether the FDA properly approved mifepristone in 2000 if it takes the case. If the lower court rulings against mifepristone ultimately stand, access to abortion could face restrictions even in some states where the procedure remains legal.

☆ Supreme Court lifts abortion pill restrictions for now
▼ + stars: | 2023-04-14 | by ( Spencer Kimball | ) www.cnbc.com time to read: +1 min

U.S. Supreme Court Justice Samuel Alito on Friday temporarily blocked lower court rulings that imposed tighter restrictions on the abortion pill mifepristone. U.S. Judge Matthew Kacsmaryk of the U.S. Northern District of Texas suspended the Food and Drug Administration's approval of mifepristone last week. The U.S. 5th Circuit Court of Appeals blocked that part of Kacsmaryk's order and kept the FDA approval in place. But the appeals court temporarily re-imposed tighter restrictions on how mifepristone is used and distributed, which would make it more difficult for women to access the drug. She said the lower court rulings are the first time judges have repealed the conditions of an FDA drug approval based on a disagreement over the agency's judgement about safety.

☆ Biden administration asks US Supreme Court to stop abortion pill limits
▼ + stars: | 2023-04-14 | by ( Andrew Chung | ) www.reuters.com time to read: +5 min

Danco Laboratories, the manufacturer of mifepristone, also asked the U.S. Supreme Court for similar relief on Friday. The Supreme Court has a 6-3 conservative majority. The administration said the lower court orders would have "sweeping consequences" for women who need access to mifepristone and the FDA's scientific judgment authority over drug safety. "The resulting disruption would deny women lawful access to a drug FDA deemed a safe and effective alternative to invasive surgical abortion," the Justice Department told the justices. Since last year's Supreme Court decision, 12 U.S. states have put in place outright bans while many others prohibit abortion after a certain length of pregnancy.

☆ Explainer: U.S. Supreme Court presses pause on abortion pill case for 5 days, What happens next?
▼ + stars: | 2023-04-14 | by ( Brendan Pierson | Thomson Reuters | Brendan Pierson Reports On Product Liability Litigation | ) www.reuters.com time to read: +6 min

HOW DID IT REACH THE SUPREME COURT? Circuit Court of Appeals for an emergency stay putting his injunction on hold. Whether or not the Supreme Court decides to stay Kacsmaryk's order, it will not decide the merits of the case. WHAT HAPPENS AFTER THE SUPREME COURT RULES? Once it does come, the losing side will again have the chance to appeal to the 5th Circuit and, eventually, the Supreme Court.

[1/2] 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. However, the appeals court declined to block portions of Kacsmaryk's order, effectively reinstating restrictions on the pill's distribution that had been lifted since 2016. The FDA and lawyers for the groups suing to block the drug could not immediately be reached for comment. The lawsuit before Kacsmaryk was filed against the FDA in November by four anti-abortion groups led by the recently formed Alliance for Hippocratic Medicine and four anti-abortion doctors. Reporting By Brendan Pierson in New York, Editing by Alexia Garamfalvi, Bill Berkrot and William MallardOur Standards: The Thomson Reuters Trust Principles.

An appeals court put part of that decision on hold late Wednesday, preserving access to the pill for now, with significant restrictions the Justice Department will ask the Supreme Court to lift. Neither Kacsmaryk's order, known as a preliminary injunction, nor the 5th Circuit's emergency stay is a final ruling on the merits of the case. REUTERS/Evelyn HocksteinThe Biden administration said on Thursday it will appeal to the Supreme Court for an emergency stay of Kacsmaryk's order in full. If the FDA wins a stay from the Supreme Court blocking the injunction, mifepristone will remain available with no new restrictions. Once it does come, the losing side will again have the chance to appeal to the 5th Circuit and, eventually, the Supreme Court.

☆ Abortion pill ruling puts 'judge shopping' concerns back in spotlight
▼ + stars: | 2023-04-12 | by ( Kevin Breuninger | ) www.cnbc.com time to read: +6 min

The Alliance For Hippocratic Medicine wants Judge Kacsmaryk to nullify the FDA's medical approval of mifepristone, which would effectively ban the abortion pill across the US. They argue plaintiffs are skirting the usual process of assigning cases randomly — which is mainly intended to "avoid judge shopping," as one federal court explains. Medication abortion is the most common form of the procedure in the U.S.An attorney for the ADF has rebuffed accusations of judge shopping. Trump was accused of judge shopping for Florida federal Judge Aileen Cannon, whom he appointed, when he filed a sweeping lawsuit in 2022 against his former political rival Hillary Clinton in Cannon's division in Florida. Ziegler echoed the view that even the appearance of judge shopping can erode trust in the courts.

April 12 (Reuters) - Abortion opponents on Tuesday urged a U.S. appeals court to allow the suspension of Food and Drug Administration's approval of the abortion pill mifepristone, in a case with potentially far-reaching impact on how the government regulates medicine. The abortion opponents' requests came one day after the U.S. Department of Justice urged the appeals court to put U.S. District Judge Matthew Kacsmaryk's April 7 order voiding the FDA's approval on hold through the appeals process. It is not clear when the 5th Circuit will rule on extending the stay. Twelve of the 16 5th Circuit judges who hear cases are Republican appointees. Circuit Court of Appeals, No.

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.)

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.

☆ A Texas judge's abortion pill ruling was 'extraordinary' because it let doctors ban a drug they neither use nor prescribe, the DOJ said in a bid to reverse the decision
▼ + stars: | 2023-04-10 | by ( Charles R. Davis | ) www.businessinsider.com time to read: +5 min

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.'"

☆ Texas judge's ruling to ban mifepristone nationwide cites Wikipedia, contains pro-life talking points, and gets basic facts about abortion wrong: Experts say it's 'completely flawed'
▼ + stars: | 2023-04-08 | by ( Katherine Tangalakis-Lippert | Hannah Getahun | ) www.businessinsider.com time to read: +7 min

"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."

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.

☆ Federal judge stays FDA abortion pill approval, gives Biden administration time to appeal
▼ + stars: | 2023-04-07 | by ( Spencer Kimball | ) www.cnbc.com time to read: +1 min

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.

April 7 (Reuters) - A federal judge on Friday halted federal regulators' approval of the abortion pill mifepristone while a legal challenge proceeds, partially granting a request by anti-abortion groups and dealing another setback to abortion rights in the United States. A White House official said they are reviewing the abortion ruling. Kacsmaryk's ruling is a preliminary injunction that would essentially ban sales of mifepristone while the case before him continues. Some abortion providers have said that if mifepristone is unavailable, they would switch to a regimen using only misoprostol for a medication abortion. During the hearing in the case, the judge raised questions about the regulatory process used by the FDA.

Adding to the volatile legal landscape around abortion, a federal judge in Washington state on Friday issued a seemingly conflicting injunction that prevented federal regulators from altering access to the same abortion drug. Kacsmaryk's ruling is a preliminary injunction that would essentially ban sales of mifepristone while the case by anti-abortion groups before him continues. By choosing to sue in Amarillo, the plaintiffs ensured that the case would go before Kacsmaryk, a conservative former Christian activist. Circuit Court of Appeals, which has a conservative reputation, with more than two-thirds of its judges appointed by Republican presidents. The FDA in January said that the government for the first time will allow mifepristone to be dispensed at retail pharmacies.

Any impact on the FDA will depend on details of the judge's ruling in the case known as Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration. The challenge was brought by a coalition of anti-abortion groups and doctors seeking withdrawal of the FDA's mifepristone approval before U.S. District Judge Matthew Kacsmaryk of the Northern District of Texas, a conservative former Christian activist. The court could order mifepristone pulled from the market while it considers a final ruling. It would call into question the entire drug approval process, said Laurie Sobel, associate director for Women's Health Policy at the Kaiser Family Foundation. 'SO MUCH UNCERTAINTY'The possibility of its approvals being overruled would likely see the FDA become more cautious, Lee said.

Here is a snapshot of pending and passed legislation seeking to restrict or protect access in 2023. KANSAS: Although Kansans voted in favor of state abortion rights on a ballot measure last year, the Republican-led state Senate has passed a prohibition on prescribing abortion pills via telemedicine. The Republican-led state is currently enforcing a total abortion ban, with exceptions for rape, incest or the life of the mother. MONTANA: The Republican-led state Senate has passed a bill seeking to overturn a 1999 state Supreme Court ruling that found that the state constitution protected a right to abortion. SOUTH CAROLINA: Despite the fact that the state Supreme Court recently struck down a six-week abortion ban in a 3-2 vote, Republicans have introduced a near-total abortion ban and a six-week ban this year.

Small icons of scientific papers are lined up in a grid, each representing a study of medication abortion. Studies of abortion pills Each icon represents one study that reported serious complications after medication abortion. For pregnant women considering medication abortion, the alternatives would be childbirth or procedural abortion. Almost all patients will experience bleeding and pain during a medication abortion, because the pills essentially trigger a miscarriage. But the study itself notes that bleeding is expected, serious complications are rare and medication abortion is safe.

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