The Supreme Court decides on the abortion pill mifepristone

Demonstrators gather in support of abortion rights in front of the US Supreme Court in Washington, DC on April 15, 2023.

Andrew Caballero-Reynolds | AFP | Getty Images

Supreme Court Justice Samuel Alito on Wednesday issued an order allowing the abortion pill mifepristone to remain available by mail and without tightening restrictions on use until at least late Friday night.

Alito last week temporarily blocked restrictions on mifepristone imposed by lower federal courts until 11:59 p.m. Wednesday in response to an emergency request from the Justice Department and Danco Laboratories, distributor of the brand-name version of the drug Mifeprex.

These restrictions will now remain in place until Friday 11:59 p.m. due to his new order.

Alito did not explain the reason for the delay.

But it gives him and the rest of the Supreme Court two more days to consider whether to uphold lower court decisions or put restrictions on mifepristone into effect if a complicated litigation over the drug plays out.

Two separate federal courts have given the Food and Drug Administration conflicting rulings on the drug’s availability.

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

The U.S. Fifth Circuit Court of Appeals partially blocked Kacsmaryk’s sweeping order days later, leaving the FDA approval in place but imposing strict restrictions on the use and distribution of mifepristone. Although this ruling keeps mifepristone on the market, the restrictions are so pervasive that many women would not have access to the drug even in some states where abortion is legal.

Shortly after Kacsmaryk’s ruling, US Judge Thomas Rice of Washington State’s Eastern District barred the FDA from restricting the availability of mifepristone in 17 states and Washington DC

Mifepristone, used in combination with another drug called misoprostol, is the most common method of terminating a 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 marked the first time a federal court overturned an FDA decision that a drug is safe and effective, according to court filings from the Justice Department, former FDA officials and the pharmaceutical industry.

Ex-President Donald Trump appointed Kacsmaryk. Senate Democrats unanimously rejected his nomination over concerns about his position on abortion and LGBTQ rights.

The appeals court’s restrictions included blocking postal delivery of the drug, reintroducing doctor visits as a condition of receiving the drug, and reducing the time women can take the pill until the seventh week of pregnancy. The court also blocked the generic version of mifepristone, which is made by a second company, GenBioPro, which supplies about two-thirds of the drug for the US market.

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The decision by 5th Circuit Justices Kurt Engelhardt and Andrew Oldham, also appointed by Trump, essentially reversed all actions taken by the FDA to make mifepristone easier for women to access.

The Justice Department told the Supreme Court that by complying with the 5th Circuit’s decision, the government would be in violation of Rice’s order to allow access in 18 jurisdictions.

The Alliance Defending Freedom, the anti-abortion group that has filed the lawsuit challenging the FDA’s approval of mifepristone, has asked the Supreme Court to keep restrictions on the drug. It has been argued that the limits provide important safeguards to keep patients safe. The legal organization represents a group of anti-abortion doctors who call themselves the Alliance for Hippocratic Medicine.

The Alliance Defending Freedom says it helped draft the Mississippi law that ultimately led the Supreme Court to rule Roe v. Wade, the landmark 1973 decision that guaranteed abortion as a constitutional right nationwide. The group says it is dedicated “to protecting freedom of religion, freedom of speech, the sanctity of life, parental rights and God’s plan for marriage and the family.”

The Justice Department and Danco said the lower court rulings would effectively take mifepristone off the market for months as the FDA adjusts the drug’s labeling to comply with the appeals court order. This would deny many women access to an FDA-approved drug that offers a safe and effective alternative to surgical abortions, they argued.

Anti-abortion groups have claimed that the way the FDA approved mifepristone was illegal, arguing that the drug is unsafe. These claims have been fiercely disputed by former FDA officials, leading medical associations, the pharmaceutical industry, 23 US states and hundreds of members of Congress.

They say the FDA conducted a rigorous review that found mifepristone to be safe and effective, backed up by decades of subsequent data.

A group of drugmakers, including Pfizer, biotech executives and investors, told the Supreme Court that upholding the lower court’s rulings “would shake the FDA’s gold standard for scientific safety and efficacy testing.” Former FDA officials told the Supreme Court that the agency’s rulings would effectively open an open season allowing it to sue competing drug companies or anyone who claims to have had an adverse reaction to a drug in order to take treatments off the market.

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