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Analysis-Abortion pills over the counter? Experts see major hurdles in widening U.S. access

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© Reuters. FILE PHOTO: A pill of Misoprostol, used to terminate early pregnancies, is displayed in a pharmacy in Provo, Utah, U.S. May 12, 2022. REUTERS/George Frey

By Ahmed Aboulenein

WASHINGTON (Reuters) – A pill used to terminate early pregnancies is unlikely to become available without a prescription for years, if ever, experts say, as the conservative-leaning U.S. Supreme Court is expected to dramatically curb abortion rights in the coming weeks.

The Biden administration is considering several options to increase access to so-called medication abortions, which can be administered at home, to help women in the many U.S. states that are expected to severely limit or outright ban abortions following the upcoming Supreme Court ruling.

The pill, mifepristone, is used in combination with a second drug called misoprostol to induce an abortion up to 10 weeks into a pregnancy and is heavily restricted – only available through a certified doctor’s prescription. Abortion rights activists have stepped up calls to make it available for anyone to buy at pharmacies without a prescription.

    Medical and regulatory experts interviewed by Reuters say the process could take years. Drugmakers would need to conduct new studies showing that a consumer can safely use the product based on directions on its packaging, without the guidance of a doctor or other provider.

    The two companies that make the pill for the U.S. market have shown no interest in doing so. Should they choose to conduct the research, any approval from the U.S. Food and Drug Administration (FDA) would become a target for lawsuits from abortion opponents that could delay implementation for years, they say.

     “The hard part that I see is getting the evidence or the agreement that no prescriber is needed at all,” said Susan Wood, a former Assistant Commissioner for Women’s Health at the FDA.

    “I personally don’t see it happening in the next couple of years,” said Wood, now director of George Washington University’s Jacobs Institute of Women’s Health.

    The Supreme Court is due to decide on a new case that could overturn the landmark Roe v. Wade ruling that made abortion legal in the country in 1973. Last month, a leaked draft ruling suggested that a majority of justices back reversing the decision. Should that happen, nearly half of the 50 U.S. states are expected to ban or heavily restrict the procedure – which would dramatically limit access for millions of women.

THE NEXT BATTLE

    Access to abortion pills is expected to become the next big battle, as their use is harder to track. The FDA has already made it easier for certified doctors to prescribe the pills by relaxing some restrictions.

The agency now allows doctors certified to prescribe mifepristone to do so after a telehealth visit rather than in-person and patients can receive it by mail, making it easier for women in U.S. states that already restrict its use.

The White House has already considered making abortion pills available online and from pharmacies abroad, with a prescription. However, the importation possibility has already been curtailed by Congress in broader legislation about drug regulation.

    An over-the-counter designation would make it much easier for pregnant women to access the pills in states that seek to restrict their use. For example, they could more easily be mailed to a patient from a friend or supporter in a state where they are not banned.

An FDA spokesperson declined to comment on whether over-the-counter use of abortion pills has been considered. A spokesperson for Danco Laboratories, a manufacturer of mifepristone, said that it does not plan to seek over-the-counter approval. GenBioPro, the second maker of mifepristone for the U.S. market, did not respond to requests for comment.

    ARE THEY SAFE?

Medication abortion involves two drugs, taken over a day or two. The first, mifepristone, blocks the pregnancy-sustaining hormone progesterone. The second, misoprostol, induces uterine contractions.

When taken together, the pills halt the pregnancy and prompt cramping and bleeding to empty the uterus, in a process similar to miscarriage.

    Abortion rights activists say the pills have a long track record of being safe and effective, with no risk of overdose or addiction. In several countries, including India and Mexico, women can buy mifepristone and misoprostol without a prescription to induce abortion.

    “Medication abortion really does meet all the FDA criteria for an over-the-counter switch,” said Antonia Biggs, associate professor at the University of California, San Francisco’s Obstetrics, Gynecology and Reproductive Sciences department.

    A study by Biggs and colleagues found that the majority of participants would understand a medication abortion over-the-counter label. Biggs said she was not in talks with drugmakers over her research.

The Charlotte Lozier Institute and Susan B. Anthony List, which advocate against abortion, have said that the FDA decision to relax restrictions on mifepristone ignored data on complications and put women at risk.

    Others point to the decade-long legal fight for over-the-counter Plan B, a form of emergency contraception taken within days of sexual intercourse to prevent a pregnancy. Approval for women 18 and over was granted in 2006 and for use by women of all ages in 2013.

    “There was very strong support that you did not need a prescriber,” said Wood, who resigned from the FDA in 2005 over the delay.

    “Everybody under the sun agreed except for a small group of people who somehow had an enormous political influence.”

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U.S. Supreme Court overturns Roe v. Wade, ends constitutional right to abortion

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9/9

© Reuters. Demonstrators gather in front of Planned Parenthood after the United States Supreme Court ruled in the Dobbs v. Jackson Women’s Health Organization Abortion case, overturning the landmark Roe v Wade abortion decision, in St. Louis, Missouri, U.S. June 24,

2/9

By Lawrence Hurley and Andrew Chung

WASHINGTON (Reuters) -The U.S. Supreme Court on Friday overturned the landmark 1973 Roe v. Wade ruling that recognized women’s constitutional right to abortion, a decision condemned by President Joe Biden that will dramatically change life for millions of women in America and exacerbate growing tensions in a deeply polarized country.

The court, in a 6-3 ruling powered by its conservative majority, upheld a Republican-backed Mississippi law that bans abortion after 15 weeks of pregnancy. The vote was 5-4 to overturn Roe, with conservative Chief Justice John Roberts writing separately to say he would have upheld the Mississippi law without taking the additional step of erasing the Roe precedent altogether.

The reverberations of the ruling will be felt far beyond the court’s high-security confines – potentially reshaping the battlefield in November’s elections to determine whether Biden’s fellow Democrats retain control of Congress and signaling a new openness by the justices to change other long-recognized rights.

The decision will also intensify debate over the legitimacy of the court, once an unassailable cornerstone of the American democratic system but increasingly under scrutiny for its more aggressively conservative decisions on a range of issues.

The ruling restored the ability of states to ban abortion. Twenty-six states are either certain or considered likely to ban abortion. Mississippi is among 13 states with so-called trigger laws to ban abortion with Roe overturned. (For related graphic click https://tmsnrt.rs/3Njv3Cw)

In a concurring opinion that raised concerns the justices might roll back other rights, conservative Justice Clarence Thomas urged the court to reconsider past rulings protecting the right to contraception, legalizing gay marriage nationwide, and invalidating state laws banning gay sex.

The justices, in the ruling written by conservative Justice Samuel Alito, held that the Roe decision that allowed abortions performed before a fetus would be viable outside the womb – which occurs between 24 and 28 weeks of pregnancy – was wrongly decided because the U.S. Constitution makes no specific mention of abortion rights.

Women with unwanted pregnancies in large swathes of America now may face the choice of traveling to another state where the procedure remains legal and available, buying abortion pills online, or having a potentially dangerous illegal abortion.

Justice Brett Kavanaugh, in a concurring opinion, appeared to nix an idea advocated by some anti-abortion advocates that the next step is for the court to declare that the Constitution outlaws abortion. “The Constitution neither outlaws abortion nor legalizes abortion,” Kavanaugh wrote.

Kavanaugh also said that the ruling does not let states bar residents from traveling to another state to obtain an abortion, or retroactively punish people for prior abortions.

‘SAD DAY’

Biden condemned the ruling as taking an “extreme and dangerous path.”

“It’s a sad day for the court and for the country,” Biden said at the White House. “The court has done what it has never done before: expressly take away a constitutional right that is so fundamental to so many Americans.”

Empowering states to ban abortion makes the United States an outlier among developed nations on protecting reproductive rights, the Democratic president added.

Biden urged Congress to pass a law protecting abortion rights, an unlikely proposition given its partisan divisions. Biden said his administration will protect women’s access to medications approved by the U.S. Food and Drug Administration including pills for contraception and medication abortion, while also combating efforts to restrict women from traveling to other states to obtain abortions.

Britain, France and some other nations called the ruling a step backward, although the Vatican praised it, saying it challenged the world to reflect on life issues.

New Zealand Prime Minister Jacinda Ardern said the decision was “a loss for women everywhere”. “Watching the removal of a woman’s fundamental right to make decisions over their own body is incredibly upsetting,” she said in a statement.

U.S. companies including Walt Disney Co, AT&T (N:T) and Facebook (NASDAQ:META) parent Meta Platforms Inc said they will cover employees’ expenses if they now have to travel for abortion services.

‘DAMAGING CONSEQUENCES’

A draft version of Alito’s ruling indicating the court was ready to overturn Roe was leaked in May, igniting a political firestorm. Friday’s ruling largely tracked this leaked draft.

“The Constitution makes no reference to abortion, and no such right is implicitly protected by any constitutional provision,” Alito wrote in the ruling.

Roe v. Wade recognized that the right to personal privacy under the Constitution protects a woman’s ability to terminate her pregnancy. The Supreme Court in a 1992 ruling called Planned Parenthood of Southeastern Pennsylvania v. Casey reaffirmed abortion rights and prohibited laws imposing an “undue burden” on abortion access. Friday’s ruling overturned the Casey decision as well.

“Roe was egregiously wrong from the start. Its reasoning was exceptionally weak, and the decision has had damaging consequences. And far from bringing about a national settlement of the abortion issue, Roe and Casey have enflamed debate and deepened division,” Alito added.

The court’s three liberal justices – Stephen Breyer, Sonia Sotomayor and Elena Kagan – issued a jointly authored dissent.

“Whatever the exact scope of the coming laws, one result of today’s decision is certain: the curtailment of women’s rights, and of their status as free and equal citizens,” they wrote.

As a result of Friday’s ruling, “from the very moment of fertilization, a woman has no rights to speak of. A state can force her to bring a pregnancy to term, even at the steepest personal and familial costs,” the liberal justices added.

The ruling empowered states to ban abortion just a day after the court’s conservative majority issued another decision limiting the ability of states to enact gun restrictions.

The abortion and gun rulings illustrated the polarization in America on a range of issues, also including race and voting rights.

Overturning Roe was long a goal of Christian conservatives and many Republican officeholders, including former President Donald Trump, who as a candidate in 2016 promised to appoint justices to the Supreme Court who would reverse Roe. During his term he named three to the bench, all of whom joined the majority in the ruling.

Asked in a Fox News interview whether he deserved some credit for the ruling, Trump said: “God made the decision.”

Crowds gathered outside the courthouse, surrounded by a tall security fence. Anti-abortion activists erupted in cheers after the ruling, while some abortion rights supporters were in tears.

“I’m ecstatic,” said Emma Craig, 36, of Pro Life San Francisco. “Abortion is the biggest tragedy of our generation and in 50 years we’ll look back at the 50 years we’ve been under Roe v. Wade with shame.”

Hours later, protesters angered by the decision still gathered outside the court, as did crowds in cities from coast to coast including New York, Atlanta, Chicago, Denver, Los Angeles and Seattle.

House of Representatives Speaker Democrat Nancy Pelosi, a Democrat, denounced the decision, saying that a “Republican-controlled Supreme Court” has achieved that party’s “dark and extreme goal of ripping away women’s right to make their own reproductive health decisions.”

The number of U.S. abortions increased by 8% during the three years ending in 2020, reversing a 30-year trend of declining numbers, according to data https://www.guttmacher.org/article/2022/06/long-term-decline-us-abortions-reverses-showing-rising-need-abortion-supreme-court released on June 15 by the Guttmacher Institute, a research group that supports abortion rights.

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New York judge rules law allowing non-citizens to vote is unconstitutional

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© Reuters. FILE PHOTO: People take part in a rally ‘Victory Rally’ to allow non-citizen NYC residents to vote in local elections, at the steeps of the New York City Hall, in New York, U.S., December 9, 2021. REUTERS/Eduardo Munoz

By Jonathan Allen

NEW YORK (Reuters) – A New York state judge struck down a new law on Monday that gave hundreds of thousands of non-citizen residents of New York City the right to vote in municipal elections.

Judge Ralph Porzio, of New York State Supreme Court for Staten Island, ruled the law violated the state constitution, which says that ” (e)very citizen” is entitled to vote.

The City Council, which is controlled by Democrats, passed the law last December, and it went into effect after both Mayor Bill de Blasio and his successor, Eric Adams, declined to either sign it or veto it.

The law allowed an estimated 800,000 to 1 million non-citizens living in the city as lawful permanent residents of the United States or with U.S. authorization to work here to vote in elections for city-wide office, but not in state-wide or federal elections. There are currently about 6.7 million people of voting age in New York City.

The law required that a person must have been a resident of the city for at least 30 days prior to the election they wished to vote in, which critics of the law said was too short. Republicans opposed the law in part on the belief that a majority of immigrants are more likely to vote Democrat.

Proponents of the law said it enfranchised the city’s huge population of non-citizens who pay taxes and contribute to the life and culture of a city that has long been a beacon for immigrants, as symbolized by the Statue of Liberty in New York Harbor.

Opponents, including the Republican Party and New York lawmakers who sued the city, said the law unfairly and unconstitutionally diluted the power of citizens’ votes and would harm politicians by forcing them to restructure their election strategies.

There was no immediate comment from the City Council or the mayor’s office, who could challenge the ruling in a higher court.

Michael Tannousis, a Republican who represents parts of Staten Island and Brooklyn in the New York State Assembly, was one of the plaintiffs who accused the council of trying to manipulate the electoral system.

“As the son of immigrants that came to this country legally and worked tirelessly to become citizens, I consider voting to be a sacred right bestowed on American citizens,” he said in a statement. “The idea that a person can move to New York City and register to vote after 30 days is preposterous and ripe for fraud.”

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West pledges unwavering support for Ukraine as missiles strike shopping centre

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5/5

© Reuters. FILE PHOTO: A smoke rises over remains of a building destroyed by a military strike, as Russia’s attack on Ukraine continues, in Lysychansk, Luhansk region, Ukraine June 17, 2022. REUTERS/Oleksandr Ratushniak

2/5

By Pavel Polityuk and Max Hunder

KYIV (Reuters) -Western nations on Monday pledged unwavering support for Ukraine in the war with Russia, including more sanctions on Moscow and air-defence systems, as Russian forces closed in on the last big city still held by Ukrainian troops in eastern Luhansk province.

Two Russian missiles struck a crowded shopping centre in the Ukrainian city of Kremenchuk, southeast of Kyiv, killing at least 10 people and wounding 40, senior Ukrainian officials said.

“It’s useless to hope for decency and humanity from Russia,” Ukrainian President Volodymyr Zelenskiy wrote on Telegram.

Leaders of the Group of Seven major democracies, meeting at a German alpine resort, said they would keep sanctions on Russia for as long as necessary and intensify international pressure on President Vladimir Putin’s government and its ally Belarus.

“Imagine if we allowed Putin to get away with the violent acquisition of huge chunks of another country, sovereign, independent territory,” British Prime Minister Boris Johnson told the BBC.

“The lessons for that would be absolutely chilling. The point I would make to people is I think that sometimes the price of freedom is worth paying.”

The United States said it was finalising a weapons package for Ukraine that would include long-range air-defence systems – arms that Zelenskiy specifically requested when he addressed the leaders by video link on Monday.

Despite the boost from its allies, Ukraine was enduring another difficult day on the battlefront following the loss of the now-ruined city of Sievierodonetsk after weeks of bombardment and street fighting.

Russian artillery was pounding Lysychansk, its twin just across the Siverskyi Donets River, which Luhansk province governor Serhiy Gaidai said was suffering “catastrophic” damage. He urged civilians to evacuate urgently.

The General Staff of Ukraine’s Armed Forces said the Russians were trying to cut off Lysychansk from the south. Russian war planes had also struck near the city, the general staff said in its daily update.

Russian reports on Sunday that troops had already entered Lysychansk could not be confirmed by Reuters.

A Reuters reporter in Kremenchuk saw the charred husk of the shopping centre with a caved-in roof. Firefighters and soldiers were pulling out mangled metal and other debris as they searched for survivors.

Dmytro Lunin, the regional governor, said it was unlikely many survivors would be found in the smouldering rubble, because “it was a big fire and there was a lot of smoke”.

He said there was no military target nearby that Russia could have been aiming at, adding: “It’s an act of terrorism against civilians.”

Luhansk and neighbouring Donetsk province make up the Donbas region, Ukraine’s industrial heartland and a prime target for the Kremlin after Russian troops failed to take the capital Kyiv early in the war, now in its fifth month.

Russian forces also control territory in the south, including the port city of Mariupol, which fell after a long siege that left it in ruins.

A senior U.S. defence official, speaking on condition of anonymity, said that Russia had carried out about 60 strikes against Ukraine over the weekend.

The official said a weekend strike in Kyiv that hit apartments was close to a factory that made munitions for Ukrainian forces.

“AS LONG AS IT TAKES”

In his address to the G7 leaders, Zelenskiy had pleaded for more arms, U.S. and European officials said. He asked for help to export grain from Ukraine and for more sanctions on Russia.

U.S. National Security Adviser Jake Sullivan said Washington was in the process of finalising a package that included long-range air-defence systems and would meet Ukraine’s artillery ammunition needs.

The G7 nations promised to tighten the squeeze on Russia’s finances with sanctions, including a deal to cap the price of Russian oil that a U.S. official said was “close”, and promised up to $29.5 billion more for Ukraine.

“We will continue to provide financial, humanitarian, military and diplomatic support and stand with Ukraine for as long as it takes,” a G7 statement said.

NATO Secretary-General Jens Stoltenberg said its troops on high readiness would be massively boosted to over 300,000, with the Western alliance set to adopt a new strategy describing Moscow as a direct threat.

“They have chosen confrontation instead of dialogue. We regret that – but of course, then we need to respond to that reality,” he told reporters.

Russia rejected claims that it had defaulted on its external debt for the first time in more than a century, telling investors to go to Western financial agents for the cash which was sent but bondholders did not receive.

The White House said Russia had defaulted as sweeping sanctions have effectively cut the country off from the global financial system.

The war has created difficulties for countries way beyond Russia’s borders, with disruptions to food and energy exports hitting the global economy.

Russia invaded Ukraine on Feb. 24 in what the Kremlin calls a “special military operation” to rid the country of far-right nationalists and ensure Russian security. It denies targeting civilians in a conflict that has killed thousands, sent millions fleeing and laid waste to cities.

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