December 11, 2023

Demonstrators rally in support of abortion rights at the U.S. Supreme Court in Washington, DC, April 15, 2023.

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Supreme Court Justice Samuel Alito issued an order Wednesday allowing the abortion drug mifepristone to continue to be available by mail until at least late Friday night, with no stricter restrictions on how it can be used .

Alito last week temporarily blocked a restriction on mifepristone imposed by a lower federal court until 11:59 p.m. Wednesday in response to an emergency motion from the Justice Department and Danco Laboratories, a distributor of branded versions of the drug Mifeprex.

Thanks to his new order, those restrictions will now remain in place until 11:59 p.m. on Friday.

Alito did not explain the reason for the delay.

But it gave him and others Supreme Court There are still two days to consider whether to uphold the lower court ruling or allow restrictions on mifepristone to take effect in a complex drug legal dispute.

Two separate federal courts have issued conflicting rulings to the FDA on the drug’s availability.

U.S. Judge Matthew Kacsmaryk of the Northern District of Texas earlier this month suspended the FDA’s approval of mifepristone and all subsequent decisions by the agency to regulate the drug.

A few days later, the U.S. Court of Appeals for the Fifth Circuit partially blocked Kacsmaryk’s sweeping order, keeping the FDA approval in effect but imposing severe restrictions on how mifepristone can be used and distributed. While the ruling keeps mifepristone on the market, the restrictions are so broad that many women are unable to obtain the drug, even in some states where abortion is legal.

Shortly after Kacsmaryk’s ruling, U.S. Judge Thomas Rice for the Eastern District of Washington banned the FDA from restricting the availability of mifepristone in 17 states and Washington, D.C.

Mifepristone, in combination with another drug called misoprostol, is the most commonly used method of terminating pregnancy in the United States, accounting for about half of all abortions, according to the Centers for Disease Control and Prevention and the Guttmacher Institute.

Kacsmaryk’s unprecedented ruling is the first time a federal court has invalidated an FDA decision that a drug is safe and effective, according to court documents filed by the Justice Department, former FDA officials and the pharmaceutical industry.

Former President Donald Trump appointed Kacsmaryk. Senate Democrats were unanimous in opposing his nomination amid concerns about his stance on abortion and LGBTQ rights.

The appeals court’s restrictions include blocking the mailing of the drug, reintroducing a doctor’s visit as a requirement to get the drug and reducing the time women can use the drug until the seventh week of pregnancy. The court also blocked generic mifepristone made by a second company, GenBioPro, which supplies about two-thirds of the drug in the U.S. market.

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Judges Kurt Engelhardt and Andrew Oldham, also appointed by Trump, ruled in the 5th Circuit that essentially overturned the FDA’s efforts to make it easier for women to All actions taken to obtain mifepristone.

The Justice Department told the Supreme Court that complying with the Fifth Circuit ruling would put the government in violation of Rice’s order to preserve access in 18 jurisdictions.

The anti-abortion group Alliance Defending Freedom filed a lawsuit against the FDA’s approval of mifepristone, asking the Supreme Court to uphold restrictions on the drug. It believes that these restrictions provide important protections that can ensure the safety of patients. The legal organization represents a group of doctors who oppose abortion, known as the Hippocratic League of Medicine.

League for the Defense of Freedom say it helped draft mississippi law That culminated in the Supreme Court last summer overturning Roe v. Wade, the landmark 1973 decision that guaranteed abortion a constitutional right nationwide.this group says it’s dedicated “Protect religious freedom, free speech, the sanctity of life, parental rights, and God’s design for marriage and the family.”

The lower court’s ruling would essentially take mifepristone off the market for months as the FDA adjusts the drug’s label to comply with an appeals court order, the Justice Department and Danco said. This, they argue, will deny many women access to the FDA-approved drug, which is a safe and effective alternative to surgical abortion.

Anti-abortion groups have argued that the way the FDA approved mifepristone was illegal and that the drug is unsafe. The claims have been vigorously contested by former FDA officials, major medical societies, the pharmaceutical industry, 23 US states and hundreds of members of Congress.

They say the FDA conducted a rigorous review to determine that mifepristone is safe and effective, as has been borne out by decades of data.

A group of drugmakers including Pfizer, biotech executives and investors told the Supreme Court that allowing the lower court’s ruling would “break the FDA’s gold standard of scientific safety and efficacy review.” Former FDA officials told the high court that the rulings would effectively create open season for the agency, allowing competing drug companies or anyone claiming side effects from the drugs to sue to have treatments pulled from the market.