mifepristone

Supreme Court, over two dissents, upholds abortion pills sent by mail, for now

The Supreme Court on Thursday rejected an antiabortion challenge to federal regulations that permit sending pills through the mail once a patient has consulted a doctor online.

The justices granted an emergency appeal from the makers of mifepristone and set aside an order from a U.S. appeals court in Louisiana that would have made it illegal to send or receive the medication by mail.

Justices Clarence Thomas and Samuel A. Alito Jr. dissented.

“The court’s unreasoned order granting stays in this case is remarkable,” Alito wrote. “What is at stake is the perpetration of a scheme to undermine our decision in Dobbs v. Jackson Women’s Health Organization, which restored the right of each State to decide how to regulate abortions within its borders.”

The decision is a setback for abortion opponents, including Louisiana Atty. Gen. Liz Murrill, who sued and argued that her state’s ban on abortion has been thwarted by abortion pills sent by mail.

Thursday’s order preserves access to the medication under the current rules, but it is not a final decision.

The case will now return to the 5th Circuit Court in New Orleans for further review.

“Today’s ruling buys time, but no peace of mind,” said Nancy Northup, president of the Center for Reproductive Rights. “Mifepristone access remains highly at risk as this case moves forward and the Trump administration conducts a politically motivated review of this pill with the hardly disguised aim of making it harder to get.”

National Right to Life expressed deep disappointment.

“Women facing unexpected pregnancies deserve real medical care and support, not a one-size-fits-all mail-order abortion system that minimizes risks and leaves women isolated during medical emergencies,” said Carol Tobias, the group’s president.

The legal dispute has put the Trump administration in a politically awkward spot.

Critics of abortion, including Republican attorneys general from 23 states, argued that the regulations adopted during the Biden administration have thwarted their state laws and allowed patients to obtain medication from doctors in California and New York.

But the Trump administration has shown no urgency to change the regulations that allow for dispensing the pills by mail.

Alito, who spoke at the 5th Circuit a week ago, said he agreed with the state’s argument.

“Louisiana’s efforts have been thwarted by certain medical providers, private organizations, and States that abhor laws like Louisiana’s and seek to undermine their enforcement,” he wrote. “These medical providers and private organizations have developed an operation enabling women in Louisiana and other States that restrict abortions to place an online order for a pill called mifepristone that induces abortion.”

Thomas said abortion is a crime in Louisiana.

The makers of the abortion pills have no grounds to sue “based on lost profits from their criminal enterprise. They cannot, in any legally relevant sense, be irreparably harmed by a court order that makes it more difficult for them to commit crimes.”

But most of the court’s conservatives refused to go along, even though they had voted to overturn the constitutional right to abortion.

Chief Justice John G. Roberts and Justices Neil M. Gorsuch, Brett M. Kavanaugh and Amy Coney Barrett refused to block the current regulations on a fast-track appeal.

Two years ago, the court handed down a similar decision involving abortion pills and the 5th Circuit Court.

The justices overturned a 5th Circuit ruling on the grounds that the antiabortion doctors who sued had no standing because they did not prescribe or use the medication.

In 2000, the FDA approved the use of mifepristone as safe and effective for ending an early pregnancy or treating a miscarriage. It is used in combination with a second drug misoprostol, which induces cramping.

Since 2016, the FDA has relaxed regulations on its use. They include a requirement that women obtain the pills directly from a doctor or a medical clinic. However, it was understood the medication would be taken later at home.

The agency temporarily suspended this rule in 2021 in response to the COVID-19 pandemic, then lifted it entirely in 2023.

Medication abortions now account for almost two-thirds of abortions in the United States, and telehealth is used in 27% of abortions nationwide. Last year, in response to abortion opponents, the Trump administration agreed to review the safety record of mifepristone.

“Mifepristone is one of the safest and most well-studied drugs on the market,” said Dr. Camille A. Clare, president of the American College of Obstetricians & Gynecologists. “The FDA removed the in-person dispensing requirement after careful evaluation of the data because mifepristone is safe and effective even when distributed by mail.”

But the Louisiana attorney general decided to sue in federal court without waiting for the FDA.

She argued that the mailing of abortion medication, which was approved under the Biden administration, was undermining her state’s strict ban on abortions.

A federal judge in Louisiana said the state appeared to have a strong claim, but he decided not to rule on it until the FDA completed its review.

The 5th Circuit Court of Appeals responded a few days later by ruling the FDA erred by relaxing its regulations to allow for dispensing the pills by mail. The three-judge panel then put its ruling into effect immediately on May 1.

Abortion law experts called out the decision as extreme and unusual.

“To our knowledge, no court has ever ordered the FDA to reimpose on a drug a safety rule the agency has thoroughly studied and deemed unnecessary,” said Melissa Goodman, executive director of UCLA’s Center for Reproductive Health, Law and Policy.

Source link

Supreme Court temporarily extends access to a widely used abortion pill

The Supreme Court is leaving access to a widely used abortion pill untouched until at least Thursday, while the justices consider whether to allow restrictions on the drug, mifepristone, to take effect.

Justice Samuel A. Alito Jr.’s order Monday allows women seeking abortions to continue obtaining the pill at pharmacies or through the mail, without an in-person visit to a doctor. It prevents restrictions on mifepristone imposed by a federal appeals court from taking effect for the time being.

The court is dealing with its latest abortion controversy four years after its conservative majority overturned Roe vs. Wade and allowed more than a dozen states to effectively ban abortion outright.

The case before the court stems from a lawsuit Louisiana filed to roll back the Food and Drug Administration’s rules on how mifepristone can be prescribed. The state claims the policy undermines the ban there, and it questions the safety of the drug, which was first approved in 2000 and has repeatedly been deemed safe and effective by FDA scientists.

Lower courts concluded that Louisiana is likely to prevail, and a three-judge panel of the U.S. 5th Circuit Court of Appeals ruled that mail access and telehealth visits should be suspended while the case plays out.

The drug is most often used for abortion in combination with another drug, misoprostol. Medication abortions accounted for nearly two-thirds of all abortions in the U.S. in 2023, the last year for which statistics are available.

The current dispute is similar to one that reached the court three years ago.

Lower courts then also sought to restrict access to mifepristone, in a case brought by physicians who oppose abortion. They filed suit in the months after the court overturned Roe.

The Supreme Court blocked the 5th Circuit ruling from taking effect over the dissenting votes of Alito and Justice Clarence Thomas. Then, in 2024, the high court unanimously dismissed the doctors’ suit, reasoning they did not have the legal right, or standing, to sue.

In the current dispute, mainstream medical groups, the pharmaceutical industry and Democratic members of Congress have weighed in cautioning the court against limiting access to the drug. Pharmaceutical companies said a ruling for abortion opponents would upend the drug approval process.

The FDA has eased a number of restrictions initially placed on the drug, including who can prescribe it, how it is dispensed and what kinds of safety complications must be reported.

Despite those determinations, abortion opponents have been challenging the safety of mifepristone for more than 25 years. They have filed a series of petitions and lawsuits against the agency, generally alleging that it violated federal law by overlooking safety issues with the pill.

President Trump’s administration has been unusually quiet at the Supreme Court. It declined to file a written brief recommending what the court should do, even though federal regulations are at issue.

The case puts Trump’s Republican administration in a difficult place. Trump has relied on the political support of antiabortion groups but has also seen ballot question and poll results that show Americans generally support abortion rights.

Both sides took the silence as an implicit endorsement of the appellate ruling. Alito is both the justice in charge of handling emergency appeals from Louisiana and the author of the 2022 decision that declared abortion is not a constitutional right and returned the issue to the states.

Sherman, Mulvihill and Perrone write for the Associated Press. Mulvihill reported from Haddonfield, N.J.

Source link

Louisiana urges Supreme Court to block abortion pills sent by mail

Louisiana’s state attorneys on Thursday urged the Supreme Court to stand aside for now and to uphold an appeals court ruling that would stop the mailing of abortion pills nationwide.

They blamed former President Biden for undermining the state’s strict bans on abortion and the Trump administration for slow-walking a study on the federal regulations that permit sending the pills through the mail.

The justices are likely to act soon on emergency appeals filed by two makers of mifepristone. They argued the pills have been shown to be safe and effective for ending an early pregnancy.

But last week, the conservative 5th Circuit Court of Appeals in New Orleans ruled for Louisiana and revived an earlier regulation that would require women to obtain the pills in person from a doctor.

The three-judge panel also took the unusual step for putting its order into effect immediately. On Monday, Justice Samuel A. Alito, who oversees the 5th Circuit, issued an administrative stay that will keep the case on hold through Monday.

The justices have to decide whether Louisiana had standing to sue over the federal drug regulations, and if so, whether judges have the authority to overrule the Food and Drug Administration.

Two years ago, the Supreme Court by a 9-0 vote dismissed a similar challenge to the abortion pills that came from the 5th Circuit. And Chief Justice John G. Roberts has said in the past that judges should usually defer to the federal agency that is responsible fo regulating drugs.

In response to anti-abortion advocates, Trump’s Health and Human Services Secretary Robert F. Kennedy Jr. agreed to have the FDA review the safety record of mifepristone.

It was approved in 2000 as safe and effective for ending early pregnancies. And in the past decade, the agency had relaxed earlier restrictions, including a requirement that pregnant women visit a doctor’s office to obtain the pills.

But the FDA said last month its review is far from complete.

In October, Louisiana Atty. Gen. Liz Murrill decided to bypass the FDA review and went to federal court seeking a ruling that would prevent the pills being sent by mail.

A federal judge refused to decide on the issue while the FDA was undertaking its review. But the 5th Circuit chose to act now. The Louisiana state attorney put the focus on the Biden administration.

When the Supreme Court was considering the Dobbs case, which overruled Roe vs. Wade and the right to abortion, “the Biden Administration was preparing a plan that predictably would undermine that decision,” she wrote in Thursday’s response.

“Although Louisiana law generally prohibits abortion and the dispensing of mifepristone to pregnant women, out-of-state prescribers—freed from the in-person dispensing requirement — are causing approximately 1,000 illegal abortions in Louisiana each month by mailing FDA-approved mifepristone into the state,” she said.

The Trump administration has yet to tell the court of its views on this case.

Source link

Supreme Court puts hold on ruling that would block mailing of abortion pills

The Supreme Court took a first step on Monday to consider anti-abortion challenges to medication that has been commonly used to end early pregnancies for 25 years.

The justices moved quickly to put on hold an appeals court ruling that would block the mailing of abortion pills nationwide. Justice Samuel A. Alito issued a temporary “administrative stay” until May 11.

Three years ago, the court blocked a similar challenge to abortion pills, ruling that anti-abortion doctors had no grounds to sue over medication they did not use or prescribe.

Last year, Louisiana’s state lawyers sued and argued their state ban on abortions is thwarted if women can receive abortion pills through the mail after consulting a doctor online.

They questioned the federal regulation that permits doctors to prescribe the medication without seeing patients in person.

On Friday evening, the conservative U.S. 5th Circuit Court of Appeals in New Orleans jolted abortion rights advocates, first by ruling this claim is likely to succeed and then by putting their order into effect immediately.

Judge Kyle Duncan, a President Trump appointee, said the Food and Drug Administration had “failed to adequately study whether remotely prescribing mifepristone is safe.”

Moreover, women may suffer “irreparable harm” if these mail-order prescriptions are allowed to continue, he said.

If upheld, the order would go far beyond Louisiana and make it illegal for women in California and other states to obtain the pills through a pharmacy or by mail if they did not see a doctor first.

The legal dispute may put the Trump administration in an uncomfortable spot. In response to the abortion critics, the FDA agreed to review the safety of prescribing these commonly used pills without a required trip to a doctor’s office.

Its review is not likely to be completed until after the November elections.

The 5th Circuit judges said they were not prepared to wait for the outcome of that review.

On Saturday, two makers of mifepristone — Danco Laboratories and GenBioPro — filed emergency appeals asking the justices to block the 5th Circuit’s order.

“Never before has a federal court” rejected a long-standing drug approval by the FDA, they said, and restricted its distribution based on claims the agency had rejected.

The justices asked for a response from Louisiana by Thursday.

Mifepristone was approved in 2000 as a safe and effective way to an early pregnancy. It is typically used in combination with a second drug — misoprostol — which is not affected by the court’s decision.

If mifepristone becomes unavailable, women may use misoprostol alone, abortion rights advocates say.

In recent years, the majority of abortions in this country result from the use of medication.

Alito is responsible for emergency appeals from the 5th Circuit, and Monday’s order does not signal what the court will decide.

“This ruling is not final — keep watching,” said Nancy Northup, president of the Center for Reproductive Rights. “Getting abortion pills through telehealth has been a lifeline for women since Roe v. Wade was overturned. Louisiana’s attempt to restrict access is political and not based in science or medicine. Americans deserve access to this critical drug that has been FDA approved for 25 years.”

Carol Tobias, president of National Right to Life, agreed the court’s order did not resolve anything.

“It is a temporary procedural step that leaves unresolved the very real concerns about the safety of these drugs and the decision under the Biden administration’s FDA to recklessly remove longstanding safeguards,” she said.

California Atty. Gen. Rob Bonta joined with 21 other state attorneys in urging the court to block the 5th Circuit’s decision.

“Telehealth has made it easier for women — especially in rural, low-income, and underserved communities — to access mifepristone and obtain reproductive health care,” he said. “We should be guided by science, not politics. The in-person dispensing requirement was eliminated because it was medically unnecessary, and there is still no basis for reinstating it.”

Source link

Mifepristone ruling is biggest obstacle to abortion access since end of Roe

In the biggest jolt to abortion policy in the U.S. since the overturning of Roe vs. Wade, a federal appeals court has restricted access to one of the most common ways to end early pregnancies by blocking the mailing of mifepristone prescriptions.

The unanimous ruling Friday from the New Orleans-based 5th U.S. Circuit Court of Appeals marks a substantial victory for abortion opponents seeking to stem the flow of abortion pills prescribed online that they view as subverting state bans on the procedure.

The ruling, which is expected to be appealed to the U.S. Supreme Court, requires that mifepristone be distributed only in person and at clinics, overruling regulations set by the federal Food and Drug Administration.

Friday’s ruling is in effect while the case works its way through the courts, but a mifepristone maker has asked the appellate court to put its ruling on hold until the Supreme Court weighs in.

Here’s what to know.

Nationwide impact

Frustrated with a lack of federal action against medicated abortions, Louisiana Atty. Gen. Liz Murrill sued the FDA last month, saying its regulations undermined the state’s ban on abortions at all stages of pregnancy.

“The regulation creates an effective way for an out-of-state prescriber to place the drug in the hands of Louisianans in defiance of Louisiana law,” Judge Kyle Duncan, who was appointed by President Trump, wrote in the ruling.

FDA officials have said the agency is conducting a new review of mifepristone’s safety, but the appeals court noted that there was no timeline for its completion.

Friday’s ruling affects all states, even those without abortion restrictions.

There is little precedent for a federal court overruling the scientific regulations of the FDA, and it remains to be seen how the decision could affect how the drug is dispensed long-term.

Murrill, a Republican, celebrated the ruling as a “victory for life,” while other antiabortion advocates cheered the reversal of rules finalized under President Biden that ended a long-standing requirement that the pills be obtained in person at a doctor’s visit.

Representatives for the FDA and the U.S. Department of Justice did not immediately respond to requests for comment.

Long record as safe and effective

Danco Laboratories, a mifepristone manufacturer and defendant in the lawsuit, has asked the appeals court to put its order on hold for one week to give the company time to seek relief from the Supreme Court.

Mifepristone was approved in 2000 as a safe and effective way to end early pregnancies. It is typically used in combination with a second drug, misoprostol, which is not affected by the ruling but is less effective on its own.

Surveys have found that the majority of abortions in the U.S. are administered using pills and that about 1 in 4 abortions nationally are prescribed via telehealth. Providers have suggested that its availability through telehealth is a reason why the number of abortions in the U.S. has not fallen since the Supreme Court overturned Roe in 2022.

As a result, abortion pills and those who prescribe them out of state have become key targets of abortion opponents.

Some Democratic-led states have adopted laws that aim to protect providers who prescribe via telehealth and mail the pills to states with bans. Those so-called shield laws are being tested through civil and criminal cases in Louisiana and Texas.

One telehealth provider in a state with a shield law, Dr. Angel Foster, was working with legal experts to understand how the ruling would affect her organization, the Massachusetts Medication Abortion Project.

“We will do everything in our power to continue providing care to people in all 50 states,” she said.

Midterm politics

The case could make abortion a key issue in this fall’s midterm elections as Democrats aim to take back control of the U.S. House and Senate and Republicans fight to hold on to their narrow majorities.

Recent electoral results suggest that voters seeking to maintain abortion access have the political momentum. Since Roe was overturned, abortion has been on the ballot directly in 17 states. Voters have sided with the abortion rights side in 14 of those results.

Abortion rights supporter Fatima Goss Graves, president and chief executive of the National Women’s Law Center, slammed Friday’s ruling as “deeply out of step with both the public and fact-based science.”

Trump received criticism after the ruling from some antiabortion advocates who expressed frustration that he did not take action himself to block distribution of the pill.

The FDA under Trump approved another generic version of mifepristone last year, which peeved some allies of the president.

“It’s shameful that the Trump administration’s inaction has forced pro-life states to take their battle to the federal courts,” said Marjorie Dannenfelser, president of Susan B. Anthony Pro-Life America, who also applauded the ruling.

Schoenbaum and Mulvihill write for the Associated Press.

Source link

Court restricts mifepristone access nationwide

A federal appeals court has restricted access to one of the most common means of abortion in the U.S. by blocking mailing of mifepristone prescriptions.

Friday’s unanimous ruling from a three-judge panel of the New Orleans-based 5th U.S. Circuit Court of Appeals is requiring that the abortion pill be distributed only in person and at clinics, overruling regulations set by the federal Food and Drug Administration.

The ruling, which is likely to be appealed to the U.S. Supreme Court, is the biggest jolt to abortion policy in the U.S. since the 2022 Supreme Court ruling that overturned Roe vs. Wade and allowed states to enforce abortion bans.

In the ruling, Judge Kyle Duncan, who was appointed by President Trump, agreed with the state of Louisiana’s contention that allowing the drug to be mailed there makes moot the state’s ban on abortion at all stages of pregnancy.

“Every abortion facilitated by FDA’s action cancels Louisiana’s ban on medical abortions and undermines its policy that ‘every unborn child is a human being from the moment of conception and is, therefore, a legal person,’” the ruling states.

Commonplace treatment

Mifepristone was approved in 2000 as a safe and effective way to end early pregnancies. It is typically used in combination with a second drug, misoprostol.

Surveys have found that the majority of abortions in the U.S. are provided via pills and that about 1 in 4 abortions nationally are prescribed via telehealth.

One survey of abortion providers last year estimated that more women in states where abortion is banned obtained abortions that way than by traveling to other states.

Some Democratic-led states have laws that seek to protect providers who prescribe via telehealth to patients in places with bans.

That rise in prominence is why abortion opponents have targeted the pills in legislation and litigation.

Little precedent

There is little precedent for a federal court overruling the scientific regulations of the FDA, and it wasn’t immediately clear how quickly or completely the decision would affect mailing of the drug throughout the country.

Judges have long deferred to the agency’s judgments on the safety and appropriate regulation of drugs.

FDA officials under Trump have repeatedly stated that the agency is conducting a new review of mifepristone’s safety, at the direction of the president.

The judges, all nominated by Republican presidents, noted in their ruling that the FDA “could not say when that review might be complete and admitted it was still collecting data.”

Because of rare cases of excessive bleeding, the FDA initially imposed strict limits on who could prescribe and distribute the pill — only specially certified physicians and only after an in-person appointment where the person would receive the pill.

Both requirements were dropped during the COVID-19 emergency. At the time, FDA officials under President Biden said that after more than 20 years of monitoring mifepristone use, and reviewing dozens of studies involving thousands of women, it was clear that women could safely use the pill without direct supervision.

GenBioPro, which makes generic mifepristone, said in a statement that the court’s decision “ignores the FDA’s rigorous science and decades of safe use of mifepristone in a case pursued by extremist abortion opponents.”

Broader impact

In a court filing, Louisiana’s attorney general and a woman who said she was coerced into taking abortion pills requested that the FDA rules be rolled back to when the pills were allowed to be prescribed and dispensed only in person.

A Louisiana-based federal judge last month ruled that those allowances undermined the state’s abortion ban but stopped short of undoing the regulations immediately.

Friday’s ruling is in effect as the case works its way through the courts and extends beyond Louisiana and other states with abortion bans.

Telehealth prescriptions have become common even in states where abortion is allowed — and the ruling blocks them there, too.

“This is going to affect patients’ access to abortion and miscarriage care in every state in the nation,” said Julia Kaye, an ACLU lawyer. “When telemedicine is restricted, rural communities, people with low incomes, people with disabilities, survivors of intimate partner violence and communities of color suffer the most.”

The National Right to Life Committee said the ruling “restores a critical layer of oversight” in women’s health.

“Women deserve better than an abortion-by-mail system that prioritizes ideology over safety,” said Carol Tobias, the group’s president.

Next step

Friday’s ruling sets up a likely appeal to the Supreme Court.

“I look forward to continuing to defend women and babies as this case continues,” Louisiana Atty. Gen. Liz Murrill, a Republican, said in a statement.

The conservative-majority high court overturned abortion as a nationwide right in 2022 but unanimously preserved access to mifepristone two years later.

That 2024 decision sidestepped the core issues, however, by ruling that the antiabortion doctors behind the case didn’t have legal standing to sue.

Representatives for the FDA and the U.S. Department of Justice did not immediately respond to requests for comment Friday evening.

In the meantime, antiabortion groups are celebrating Friday’s ruling. Marjorie Dannenfelser, president of Susan B. Anthony Pro-Life America, applauded the ruling as “a huge victory for victims and survivors of Biden’s reckless mail-order abortion drug regime.” She also criticized the Trump administration for taking time to conduct its own review of mifepristone, saying its slow movement has forced states to take action.

“Women and children suffer and state sovereignty is violated every day the FDA allows abortion drugs to flood the mail,” Dannenfelser said.

Mulvihill and Schoenbaum write for the Associated Press. AP writers John Hanna, Matthew Perrone and Lindsay Whitehurst contributed to this report.

Source link