Connect with us

HEALTH

Abortion drug mifepristone still legal, Supreme Court rules

Published

on

The Supreme Court ruled Friday that mifepristone, the leading abortion drug, will remain legal for the time being as an appeal moves forward in a case that could have far-reaching implications for reproductive rights and the powers of the Food and Drug Administration. A court ruled by a conservative Donald Trump-appointed judge in Texas to ban the drug as the appeal goes through the U.S. Fifth Circuit Court of Appeals. This is a temporary victory for the Biden administration in its fight to protect access to abortion in the post-conflict period.caviar America. Mifepristone, along with misoprostol, used more than half of all abortions in the US.

The Supreme Court decision is the latest twist in a closely watched legal dispute between Biden’s Justice Department and Alliance Defending Freedom, a conservative legal group that sued the FDA over its 2000 approval of mifepristone. The mifepristone case is one of the most far-reaching anti-abortion efforts to reach the Supreme Court since the judges overturned the decision. Row vs Calf last June.

The trial began in Texas, where Trump-appointed conservative Judge Matthew Kaczmarik earlier this month ruled in the event that the FDA withdrew approval of the drug despite having been on the market for more than two decades. Attorney General Merrick Garland filed an appeal with the US Court of Appeals for the Fifth Circuit within hours. A conservative three-judge panel of the appeals court upheld the FDA’s approval of mifepristone in 2000, arguing that too much time had passed for the plaintiffs to challenge. But this was due to Kaczmarik’s decision to reverse recent FDA changes that began in 2016 that expanded access to mifepristone to allow it to be delivered to patients by mail and extended the drug’s use to 10 weeks’ gestation.

Following the decision of the Fifth Circuit Court, the Department of Justice filed an emergency petition with the Supreme Court to maintain FDA approval of mifepristone. Last Friday, Judge Samuel Alito issued an order lifting the U.S. Court of Appeals for the Fifth Circuit’s restrictions on the drug. While this mifepristone will still remain on store shelves as long as it’s an access victory, reproductive rights activists stress that this lawsuit could still have far-reaching implications.

“We are in the middle of an abortion access crisis…. There is a lot of pressure on states that have access to abortion to take care of patients who are no longer able to access this care within their state. So you’re adding this on top of that, you’re perpetuating and exacerbating an already fragile public health system – it’s dangerous,” the reproductive rights advocate said of this latest anti-abortion campaign.

The person added: “This is another attack on abortion in this country and it is politically motivated, based on neither science nor law.”

This article was originally published Vanity Fair.


HEALTH

The Supreme Court now provides wide access to abortion pills

Published

on

WASHINGTON – Supreme Court said Friday night that the abortion pill mifepristone will remain widely available for the time being, postponing the possibility of abrupt discontinuation of the drug, which is used in more than half of abortions in the United States.

The ruling halted moves that sought to limit the availability of mifepristone as the appeal progressed: a federal judge in Texas ruling to put the drug on the market completely and an appeals court ruling to impose significant barriers to the pill, including blocking access by mail.

The unsigned one-point order, which was issued hours before the restrictions went into effect, marked the second time in a year that the Supreme Court has deemed a serious attempt to drastically limit access to abortion.

Ultimately, this case could have serious implications even for states where abortion is legal, as well as for the FDA’s regulatory body for other drugs.

If the judge’s decision in Texas that quashed the FDA’s approval for the pill after more than two decades stands, it could pave the way for all sorts of problems with the agency’s approval of other drugs and allow health care providers anywhere. challenge government policies that may affect the patient.

The Biden administration asked the Supreme Court to intervene after the U.S. Fifth Circuit Court of Appeals upheld a number of restrictions in the Texas ruling, even as it said it would allow the pill to remain on the market.

In Friday’s ruling, Judges Clarence Thomas and Samuel A. Alito Jr. disagreed.

Judge Thomas did not give reasons, but Judge Alito noted that the Fifth Circuit had already narrowed down the most far-reaching aspects of the Texas decision. He added that the FDA and the manufacturer of the branded version of mifepristone, Danco Laboratories, “did not demonstrate that they could be irreparably harmed” in the appeals court case.

Judge Alito was skeptical of the FDA’s claims that “regulatory ‘chaos'” would ensue if the lower court’s decision went into effect. Citing a rival case filed by the Democratic Attorneys General of Washington, which is seen as a direct challenge to the case in Texas, he accused the FDA of using the judiciary to enforce “desired policies while evading both necessary measures.” departmental procedures and judicial control”.

Most likely, this is not the last word of the judges. After the Fifth Circuit hears the appeal, the case will likely go back to the Supreme Court.

None of the judges appointed by President Donald J. Trump publicly expressed their dissent.

The ruling is, at least temporarily, a victory for the Biden administration.

President Biden welcomed the decision, saying “the administration will continue to protect the FDA’s independent expert authority for reviewing, approving, and regulating a wide range of prescription drugs.”

The Texas ruling, he added, “would undermine the FDA’s medical opinion and endanger women’s health.”

An FDA spokesman declined to comment.

The response from the plaintiffs, a coalition of anti-abortion groups and several doctors, has been muted.

Eric Baptiste, senior adviser to Alliance Defending Freedom, the conservative legal organization that represents the coalition, said the battle will continue.

“The FDA should be held accountable for the damage it has done to the health of countless women and girls and to the rule of law by not examining how dangerous the medical abortion regime is and illegally lifting all meaningful safety measures, even allowing abortions under mail. ‘ said Mr Baptist.

After the Supreme Court overturned the constitutional right to abortion in June, political and legal battles have shifted towards medical abortion, a two-component regimen typically used in the first 12 weeks of pregnancy.

The first drug, mifepristone, blocks the reproductive hormone progesterone, and the second, misoprostol, taken one or two days later, causes contractions and helps the uterus expel its contents.

Over five million women have used mifepristone to terminate pregnancies in the United States, and dozens of other countries have approved its use.

The case came to the judges after a fast-paced and confusing battle over the legal status of the pill.

In November, the plaintiffs filed suit in the Amarillo branch of the federal judiciary in Texas, guaranteeing that the case would be heard by a single judge: Matthew J. Kachsmarik of the US District Court for the Northern District of Texas.

Judge Kaczmarik, appointed by Mr. Trump, is a longtime anti-abortion opponent and joined the court after working for the First Liberty Institute, a conservative legal group that focuses on religious freedom issues.

The coalition that filed the lawsuit, the Hippocratic Medicine Alliance, argued that the FDA misapproved the pill in 2000 and that mifepristone was unsafe. The agency strongly disputed these claims, pointing to studies that show that serious complications are rare and that less than 1 percent of patients require hospitalization.

This month, Judge Kaczmarik, in an interim order, invalidated the drug’s FDA approval and gave both parties a week to seek emergency care before the ruling takes effect.

Less than an hour later, US federal judge Thomas O. Rice, appointed by President Barack Obama, issued a controversial ruling in a separate mifepristone lawsuit. Judge Rice barred the FDA from restricting the availability of the pill in the 17 states and the District of Columbia that were parties to the lawsuit.

Competing rulings meant that the case would almost certainly go to the Supreme Court.

The FDA immediately appealed Judge Kachsmarik’s decision, and a divided three-judge panel of the Fifth Circuit in New Orleans upheld the agency’s approval for the drug, ensuring mifepristone remains on the market.

But the commission erected several barriers to entry, partly siding with Judge Kachmaryk as the suit progressed through the courts. It has blocked a number of steps the FDA has taken since 2016 to increase the availability and distribution of the drug, such as allowing it to be mailed and prescribed by non-physician healthcare professionals.

Adam Liptak another Christina Jewett made a report.

Continue Reading

HEALTH

What’s next for the abortion pill in the US?

Published

on

On Friday, the Supreme Court ruled that mifepristone would remain on the market for the time being.

Continue Reading

HEALTH

Supreme Court retains access to abortion pills for now

Published

on

WASHINGTON. On Friday, the Supreme Court retained women’s access to a drug used in the most common abortion methodoverriding lower court restrictions while the lawsuit continues.

The judges granted emergency requests from the Biden administration and New York-based Danco Laboratories, maker of the drug mifepristone. They are appealing a lower court ruling that would overturn the Food and Drug Administration’s approval of mifepristone.

The drug has been approved for use in the US since 2000 and has been used by over 5 million people. Mifepristone is used in combination with a second drug, misoprostol, in more than half of all abortions in the US.

Friday’s court action will almost certainly leave access to mifepristone unchanged for at least next year as appeals play out, including a potential appeal to the Supreme Court. The case’s next stop is at the US Court of Appeals for the Fifth Circuit in New Orleans, which set out the arguments in the case on May 17.

Two of the nine judges are Samuel Alito, the author of last year’s decision to dismiss Roe v. the United States. Wade and Clarence Thomas – voted for permission restrictions take effect, and Alito posted a four-page dissent. No other judges commented on the court’s one-paragraph decision, and the court did not release the full breakdown of the votes.

President Joe Biden has praised the high court for keeping mifepristone available while the legal battle continues.

“The rates couldn’t be higher for women across America. I will continue to fight politically motivated attacks on women’s health. But let’s be clear: the American people must continue to use their vote as a vote and elect Congress to pass legislation restoring Roe v. USA protection. Wade,” Biden said in a statement.

The Alliance Defending Freedom, which represents anti-abortion opponents challenging the FDA’s approval of mifepristone, downplayed the court’s decision.

“In accordance with normal practice, the Supreme Court has decided to maintain the status quo that existed prior to our lawsuit while our appeal against the FDA’s illegal approval of chemical abortion drugs and the withdrawal of critical warranties for these drugs moves forward,” ADF lawyer Eric Aube Baptista’s message says so.

The judges weighed the arguments that enacting the restrictions contained in the lower courts’ rulings would seriously impair the availability of mifepristone.

The Supreme Court initially said it would decide by Wednesday whether the restrictions could go into effect while the case continues. The one-sentence order, signed by Alito on Wednesday, gave the judges two extra days without explanation.

The call to mifepristone is the first abortion controversy reach the country’s highest court since its the conservative majority overturned Roe v. calf 10 months ago and allowed more than a dozen states to completely ban abortion.

By most accounts, Alito said last June that one of the reasons for Rowe’s resignation was to block federal courts from fighting abortion. “It’s time to listen to the Constitution and return the issue of abortion to the people’s deputies,” he wrote.

But even with their court victory, anti-abortion returned to federal court with a new target: medical abortions, which account for more than half of all abortions in the United States.

Women seeking to terminate their pregnancy in the first 10 weeks without a more invasive surgical abortion may take mifepristone along with misoprostol. The FDA has simplified the conditions for using mifepristone over the years, including allowing it to be mailed in states where access is allowed.

Opponents of abortion filed a lawsuit in Texas in November, arguing that the FDA’s original approval of mifepristone 23 years ago and subsequent changes were wrong.

They won the April 7 decision U.S. District Judge Matthew Kaczmarikappointed by former President Donald Trump, revoking FDA approval of mifepristone. The judge gave the Biden administration and Danco Laboratories a week to appeal and try to uphold his decision.

In response to the swift appeal, two more Trump appointees pleaded in the 5th U.S. Circuit Court of Appeals. initial FDA approval to remain in place for the time being. But Judges Andrew Oldham and Kurt Engelhardt said much of the remainder of Kaczmarik’s ruling could go into effect while the case is in federal courts.

Their decision would effectively invalidate changes made by the FDA since 2016, including extending the pregnancy from seven weeks to 10 weeks, when mifepristone can be safely used. The court would also halt the drug being mailed or sold as a generic drug, and patients seeking it would have to visit the doctor three times in person. Women could also be required to take higher doses of the drug than necessary, according to the FDA.

Administration and Danko declared that chaos would ensue if these restrictions were put in place while the case was ongoing. Potentially adding to the confusion, a federal judge in Washington ordered the FDA to maintain access to mifepristone under current regulations in 17 Democratic-led states and the District of Columbia, which filed a separate lawsuit.

The Biden administration said the rulings conflicted and created an unacceptable situation for the FDA.

Alito questioned the argument that there would be chaos as a result, stating that the administration “has not dispelled any doubt that in these cases it will obey even an unfavorable order.”

And the new legal wrinkle threatened with even greater complications. GenBioPro, which makes the generic version of mifepristone, filed a lawsuit on Wednesday to block the FDA in advance from removing the drug from the market unless the Supreme Court intervenes.

The Supreme Court was asked to block the decisions of the lower court only until the end of the trial.

The Court of Appeal has accelerated the consideration, but there is no deadline for a decision.

Any appeal to the Supreme Court will come within three months of the ruling, but judges have no time limit to decide whether to reconsider the case.

More must-read content from TIME


connect with us emails@time.com.

Continue Reading
Advertisement

Trending