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WASHINGTON, April 20 (Reuters) - Use of the drug misoprostol on its own to terminate pregnancies is on the rise in the United States as providers seek a preemptive alternative while a ban on abortion pill mifepristone is being considered in court. Misoprostol is already part of the only medication abortion protocol approved by the U.S. Food and Drug Administration, but only when taken in combination with mifepristone. The drug, which the FDA first approved in 1988 for gastric ulcers, is often prescribed off-label to treat miscarriages or induce abortions. "If providers are forced to stop providing mifepristone, misoprostol alone is also safe and effective," said Dr. Ushma Upadhyay, a public health professor at the University of California, San Francisco. Because misoprostol is approved for medication abortion in the United States as part of the two-drug combination, prescribing it alone to terminate pregnancies would also be considered off-label.

☆ 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.

☆ 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.

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.

☆ Supreme Court extends suspension of Texas ruling limiting access to abortion pill mifepristone
▼ + stars: | 2023-04-19 | by ( Associated Press | ) www.businessinsider.com time to read: +5 min

The Supreme Court gave itself more time to consider whether to allow restrictions on abortion pill mifepristone to take effect. Legal challenges to mifepristone's FDA approval continue. The justices had given themselves a deadline on Wednesday in a fast-moving case from Texas in which abortion opponents are seeking to roll back FDA approval mifepristone. 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. Mifepristone has been available for use in medication abortions in the United States since the FDA granted approval in 2000.

☆ 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.

☆ 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.

☆ 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.

☆ 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.

☆ 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.

☆ 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.

☆ 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.

April 13 (Reuters) - U.S. telehealth abortion providers scrambled on Thursday to keep their services available after a federal appeals court ruled that the abortion pill mifepristone could be distributed amid ongoing litigation but with significant restrictions. Mifepristone is used with another drug called misoprostol to perform medication abortion, which accounts for more than half of U.S. abortions. Jayaram Brindala, founder of Abortion Telemedicine, said the provider would "no longer be able to send the mifepristone medication by mail anywhere." Brindala added the company would still send the misoprostol-only regimen to states that allow it. Other telehealth practices that provide abortion medication said they were waiting to see what happens next in court before announcing any changes in policy.

☆ 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.

☆ 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.

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.

☆ Inside the Online Market for Overseas Abortion Pills
▼ + stars: | 2023-04-13 | by ( Allison Mccann | ) www.nytimes.com time to read: +17 min

A selection of abortion pill kits available online from overseas sellers. A chart of the estimated number of abortion pills provided outside the U.S. health care system from July through December 2022. For most patients, the cost of the service remains the most important factor in deciding where to get pills online. A chart showing the minimum, average and maximum cost of abortion pills from overseas providers: Aid Access, Las Libres and for-profit online sellers. A chart showing the minimum, average and maximum delivery speeds of abortion pills from overseas providers: Aid Access, Las Libres and for-profit online sellers.

☆ 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.

☆ 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.

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.

☆ New York and California are stockpiling alternative abortion pill misoprostol
▼ + stars: | 2023-04-11 | by ( Spencer Kimball | ) www.cnbc.com time to read: +1 min

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.

☆ Abortion pill alternative: The drug that could be used if Texas ban on mifepristone upheld
▼ + stars: | 2023-04-11 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

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.

☆ States where abortion is legal warn appeals court about Texas mifepristone ruling
▼ + stars: | 2023-04-11 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

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."

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.

☆ 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."

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