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☆ US Supreme Court faces self-imposed deadline to act on abortion pill curbs
▼ + stars: | 2023-04-19 | by ( Andrew Chung | ) www.reuters.com time to read: +3 min

WASHINGTON, April 19 (Reuters) - The U.S. Supreme Court on Wednesday faces a self-imposed deadline to act before significant limits on access to the abortion pill mifepristone take effect in a challenge by anti-abortion groups to the drug's federal regulatory approval. 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. In a case that could undercut federal regulatory authority over drug safety, the New Orleans-based 5th U.S. The 5th Circuit did halt a part of Kacsmaryk's order that would have suspended the U.S. Food and Drug Administration (FDA) approval of the drug in 2000 and effectively pull it off the market. Some 56% of respondents said they have an unfavorable view of the Supreme Court.

☆ Supreme Court maintains full access to abortion pill mifepristone until at least Friday
▼ + stars: | 2023-04-19 | 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. Supreme Court Justice Samuel Alito on Wednesday issued an order allowing the abortion pill mifepristone to remain available by mail delivery and without tighter restrictions on how it is used until at least late Friday night. Although that ruling keeps mifepristone on the market, the restrictions are so sweeping that many women would not have access to the medication even in some states where abortion is legal. The appeals court restrictions included blocking mail delivery of the medication, re-imposing doctor visits as a requirement to obtain the drug, and shortening the length of time women can use the pill to the seventh week of pregnancy. The court also blocked the generic version of mifepristone made by a second company, GenBioPro, which supplies about two-thirds of the medication for the U.S. market.

☆ Abortion pill company GenBioPro asks U.S. court to keep generic mifepristone on market
▼ + stars: | 2023-04-19 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

GenBioPro asked the U.S. District Court for Maryland to preemptively block the FDA from pulling the company's 2019 approval to distribute the company's version of mifepristone. GenBioPro has said in court filings that it supplies two-thirds of the mifepristone used in the U.S. for abortions. "GenBioPro will use all regulatory and legal tools to protect access to mifepristone for patients and providers." The Supreme Court last week temporarily put the appeal's court rulings on hold. But the Supreme Court as early as Wednesday could move to lift that ban or leave it in place pending further legal challenges to the rulings

☆ 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.

☆ 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.

☆ Abortion providers rush to make backup plans as Supreme Court decides whether to keep limits on mifepristone
▼ + stars: | 2023-04-14 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +6 min

Some in-person clinics in New York, California and Kansas will offer mifepristone for now, but are preparing to provide an alternative abortion pill if a subsequent decision essentially bans the drug. U.S. abortion pill providers are scrambling to make backup plans as the Supreme Court decides whether to keep restrictions on the key drug mifepristone. Those restrictions will limit access to mifepristone even in states where abortion is legal. Some in-person abortion clinics in states where the procedure is legal told CNBC that operations will remain largely the same. Other clinics in states where abortion is legal can prescribe mifepristone off-label beyond the first seven weeks of pregnancy, according to Hill.

CNN —Supreme Court Justice Samuel Alito on Friday extended a hold on a lower court ruling that would have imposed restrictions on access to an abortion drug, a temporary move meant to give the justices more time to consider the issue. The case is the most important abortion-related dispute to reach the high court since the justices overturned Roe v. Wade last term. Alito issued a so-called administrative stay on the ruling while the high court considers an emergency appeal filed by the Biden administration and a manufacturer of the drug, mifepristone. Alito issued the order because he has jurisdiction over the federal appeals court involved in the case. Prelogar, the solicitor general, argued in her filing to the Supreme Court that the FDA’s expert judgment should not be challenged.

☆ 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.

☆ 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.

☆ Supreme Court asked to block ruling that threatens access to abortion pill mifepristone
▼ + stars: | 2023-04-14 | by ( Spencer Kimball | ) www.cnbc.com time to read: +1 min

The Justice Department and the abortion pill distributor Danco Laboratories on Friday asked the Supreme Court to block an order that threatens access to mifepristone, an escalation of a legal fight that could make it harder to undergo the procedure nationwide. But the appeals court voted 2-1 to temporarily reimpose restrictions on mifepristone, which will significantly limit access to the drug even in states where abortion is legal. Mifepristone, used in combination with another drug called misoprostol, is the most common method to terminate a pregnancy in the U.S., accounting for about half of all abortions. Misoprostol, which is used a standalone abortion drug in other parts of the world, is not impacted by the lower court rulings. Prelogar said the lower court rulings would immediately make all doses of mifepristone misbranded because their labelling would not be consistent with the FDA's original approval.

☆ Ron DeSantis knows his 6-week abortion ban could come back to haunt him — that's why he's doing it under the radar
▼ + stars: | 2023-04-14 | by ( Madison Hall | ) www.businessinsider.com time to read: +4 min

Ron DeSantis signed a new law banning abortion after 6 weeks of pregnancy. He signed with almost no fanfare, especially compared to the crowd for his 15-week ban in 2022. Ron DeSantis enacted a 15-week abortion ban for people who are pregnant in April 2022, it was to much fanfare, with the governor surrounded by supporters and television crews. The 15-week abortion ban is still heading before the Florida Supreme Court, and if it's struck down, the six-week ban won't go into effect either. Seeing the recent backlash against Kacsmaryk, it makes sense why DeSantis would choose to avoid publicly signing the six-week ban in order to avoid a similar fate.

☆ Half of Republicans say politics drove US abortion-pill court ruling, Reuters/Ipsos poll shows
▼ + stars: | 2023-04-13 | by ( ) www.reuters.com time to read: +3 min

WASHINGTON, April 13 (Reuters) - Half of U.S. Republicans think a federal court was motivated by politics when it ordered the suspension of government approval for a widely used abortion pill, a Reuters/Ipsos poll completed on Wednesday found. Fifty-one percent of self-identified Republicans in the poll said they agreed that the ruling last week - which would essentially make sales of the abortion pill mifepristone illegal - was politically motivated. Fifty-one percent of Republicans in the poll, and 73% of Democrats, opposed state-level restrictions on access to abortion pills. Forty-three percent of Republicans said they were less likely to vote for a politician who supports limiting access to abortion. The Reuters/Ipsos poll gathered responses from 995 adults nationwide, including 433 self-described Democrats and 379 Republicans.

☆ U.S. appeals court allows abortion pill mifepristone to stay on the market but blocks mail delivery
▼ + stars: | 2023-04-13 | by ( Spencer Kimball | ) www.cnbc.com time to read: +4 min

A federal appeals court has allowed the abortion pill mifepristone to remain on the U.S. market for now, but it imposed major restrictions on the medication that will significantly limit access. The order bars mail delivery of the abortion pill. "If allowed to stand, the consequences of this decision will be catastrophic not just for medication abortion access, but the entire drug approval system." The Alliance Defending Freedom, the anti-abortion group that sued the FDA, said the appeals court decision restores critical safeguards while the litigation proceeds. The order does not impact misoprostol, which is commonly used as a standalone abortion medication in other parts of the world.

☆ Blocking FDA approval of abortion pill could stifle innovation in the biopharma industry, experts say
▼ + stars: | 2023-04-13 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +6 min

A messy legal fight over the Food and Drug Administration's approval of the abortion pill mifepristone poses risks to the biopharma industry that go beyond the single drug. If a subsequent decision tosses out the pill's approval, it could potentially stifle innovation in the sector and deter investments in the development of life-changing drugs, biopharma companies and experts in law and economics say. More than 200 biopharma companies made a similar claim Monday in an open letter calling for the reversal of Kacsmaryk's decision. But Hastings said biopharma companies still respect the FDA when the agency turns down their drugs. Suliman offered a more hopeful take on how the legal fight could affect biopharma innovation.

[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.

☆ Appeals court partially blocks ruling that imperils access to key abortion pill
▼ + stars: | 2023-04-13 | by ( Lawrence Hurley | Laura Jarrett | ) www.cnbc.com time to read: +6 min

A federal appeals court late on Wednesday blocked part of a ruling issued last week by a Trump-appointed judge that endangers access to the abortion pill mifepristone. The Justice Department can still ask the Supreme Court to intervene in an attempt to completely block Kacsmaryk's ruling. The Justice Department has filed a motion in the federal district court in Washington state, asking for clarification on Friday's ruling. Kacsmaryk's ruling, if allowed to stand, would not mean that access to mifepristone would immediately be cut off nationwide. The agency has broad power to do so, with the Supreme Court in a 1985 ruling saying that such decisions generally cannot be challenged in court.

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.

☆ A wide majority of Americans back abortion pills, including 71% of young women. The issue could destroy GOP election chances for a generation.
▼ + stars: | 2023-04-12 | by ( Brent D. Griffiths | ) www.businessinsider.com time to read: +5 min

Unless this trend reverses, abortion rights and other culture war issues could doom GOP candidates in general elections for decades. State Supreme Court Justice-elect Janet Protasiewicz won a double-digit victory on a platform that was explicitly built on abortion rights. The first signs that midterms would be upended by abortion came in Nebraska and Kansas, the latter of which was the first state to vote on abortion rights after Dobbs. Kansas voters ended up rejecting an amendment that would have eliminated the right to abortion from the state constitution. By the end of November, abortion rights advocates went six for six in ballot measures that either enshrined protections into law or stopped further limitations — an incredible streak that reversed years of losses.

☆ Antiabortion group says appeals court lacks authority to block Texas abortion pill ruling
▼ + stars: | 2023-04-12 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

The Alliance Defending Freedom's lead attorney, Erik Baptist, argued in a new filing to the U.S. 5th Circuit Court of Appeals late Tuesday that the court lacks authority to grant the Justice Department's request to block the decision. His decision is set to take effect a 12 a.m. central time on Saturday if the 5th Circuit does not block it. Baptist made a technical argument that Kacsmaryk's decision to suspend the approval date cannot be appealed to the 5th Circuit under federal law, in contrast to an injunction or a final court decision. He argued the case should continue to play out in the U.S. District Court for the Northern District of Texas. They called on the 5th Circuit to immediately block the judge's order from going into effect early Saturday.

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.

But even if those legal efforts fail and last Friday's order by U.S. District Judge Matthew Kacsmaryk in Amarillo, Texas goes into effect, essentially rendering the drug unapproved, the U.S. Food and Drug Administration could nonetheless continue to allow access to the drug, legal experts say. The FDA, which has said it stands behind it determination that mifepristone is safe and effective, declined to comment. CONTRADICTORY RULINGSThe FDA approved mifepristone, which is the first of a two-drug regimen to terminate a pregnancy within the first 10 weeks, in 2000. Kacsmaryk put his ruling on hold until Friday to give the Biden administration, which supports access to abortion, time to pursue its appeal. 1985 PRECEDENTBut, even if the abortion pill's approval remains suspended, the FDA has precedent on its side to do nothing, legal experts said.

☆ 5 things the Supreme Court will take into account in medication abortion case
▼ + stars: | 2023-04-12 | by ( Ariane De Vogue | ) edition.cnn.com time to read: +10 min

CNN —As the Supreme Court prepares for yet another controversial abortion case to come its way, the justices will pore over District Court Judge Matthew Kacsmaryk’s ruling last week to block the government’s approval of the key medication abortion drug at issue. “There are serious questions on whether the Supreme Court is willing to endorse the district’s court’s very broad approach to those questions,” he said. As he often does, Supreme Court Justice Brett Kavanaugh wrote separately last June to explain his thinking in voting to overturn Roe v. Wade. The Supreme Court might also take issue with the relief that Kacsmaryk ordered. None other than the liberals on the Supreme Court who dissented in Dobbs.

☆ 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.

☆ House Democrats call for immediate hearing on Texas abortion pill ruling
▼ + stars: | 2023-04-12 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

Abortion rights advocates gather in front of the J Marvin Jones Federal Building and Courthouse in Amarillo, Texas, on March 15, 2023. Democrats on the U.S. House Committee on Energy and Commerce on Wednesday requested an immediate hearing on a federal judge's order suspending the Food and Drug Administration's approval of the abortion pill mifepristone. All 23 Democrats on the committee wrote in a letter to Chair Cathy McMorris Rodgers, R-Wash., arguing that the ruling undermines the FDA's authority over the drug approval process. They alleged that the FDA failed to follow Congress' "statutorily prescribed drug approval process" by approving mifepristone in 2000. "The FDA's lawless actions ultimately endanger women and girls seeking chemical abortions," the lawmakers wrote.

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