Explanation: the US Supreme Court retains access to the abortion pill, for now: what’s next?

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By RockedBuzz 7 Min Read
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By Brendan Pierson

(RockedBuzz via Reuters) – The US Supreme Court on Friday blocked, for now, lower court orders that would have imposed new restrictions on the abortion pill mifepristone as a lawsuit filed by anti-abortion groups and doctors seeking to ban it proceeds.

But the legal battle over the drugs is far from over. Here’s what you need to know about the case as it unfolds further:

WHAT IS MEDICAL ABORTION?

Medical abortion is a two-drug regimen consisting of mifepristone followed by misoprostol used to terminate a pregnancy within the first 10 weeks. It accounts for more than half of abortions in the United States.

Two companies sell mifepristone for medical abortion in the United States: Danco Laboratories, which sells the brand name version of Mifeprex, and GenBioPro Inc, which sells a generic version.

WHAT IS THE LEGAL DISPUTE?

Last year anti-abortion medical associations led by the Texas-based Alliance for Hippocratic Medicine sued the US Food and Drug Administration in federal court in Amarillo, Texas, arguing that the agency approved mifepristone for abortion in 2000 using an illegal process and did not adequately consider the drug’s safety They asked US District Judge Matthew Kacsmaryk, presiding over the lawsuit, to revoke the drug’s approval, effectively withdrawing it from the market .

The FDA, along with major US medical associations, strongly dispute the claims. Danco intervened in the case to defend his drugs.

HOW DID THE CASE GET TO THE SUPREME COURT?

Kacsmaryk on April 7 issued a temporary order, known as a preliminary injunction, suspending the drug’s approval while the lawsuit progresses. The injunction was not a final ruling, but Kacsmaryk reasoned that the anti-abortion plaintiffs were likely to win on the merits.

The Biden and Danco administrations appealed the injunction to the New Orleans-based US 5th Circuit Court of Appeals and asked for an emergency stay order barring it from going into effect until the appeal will not have been heard and decided.

The 5th Circuit last week granted a limited stay, allowing the pill to remain on the market but with significant restrictions, including the requirement to be dispensed by a doctor in person and a limit on its use to the first seven weeks of pregnancy , down from 10. The ruling also revoked approval for the generic sold by GenBioPro.

The Biden and Danco administration immediately asked the Supreme Court to overturn the 5th Circuit and impose an emergency suspension.

WHAT DID THE SUPREME COURT DO?

The Supreme Court granted the request and stayed all of Kacsmaryk’s injunction until the 5th Circuit decides the Biden and Danco administration’s appeal, and the Supreme Court itself considers any appeals of the decision. 5th Circuit.

That means both brand-name and generic mifepristone will remain available without new restrictions until those appeals resolve, which could take months or even longer.

The Supreme Court has not ruled on the merits of the case, meaning mifepristone could still be restricted or banned at a later stage of the case.

WHAT ABOUT THE JUDGMENT FROM THE STATE OF WASHINGTON?

Minutes after Kacsmaryk’s April 7 ruling, US District Judge Thomas Rice in Spokane, Washington issued a preliminary injunction preventing the FDA from placing new restrictions on mifepristone. That ruling applies only in 17 Democratic-led states and the District of Columbia, which had argued the government should relax special safety restrictions around the pill.

The injunction was not under discussion before the Supreme Court and remains in effect. It would be in direct conflict with any future ruling restricting mifepristone, which would likely need to be resolved in another round of appeals.

ARE THERE OTHER CAUSES ABOUT THE APPROVAL OF MIFEPRISTONE?

YES. GenBioPro sued the FDA on Wednesday in federal court in Baltimore, seeking an order preventing the agency from pulling the drug from the market without going through a formal process that gives the company a chance to be heard.

GenBioPro argues that the FDA can’t just hold approval without such a process, “regardless of outside attempts to interfere.” If successful, the lawsuit would create another potential conflict with any future orders limiting mifepristone.

WHAT HAPPENS NEXT?

A panel of three 5th Circuit judges will hear the appeal arguments on May 17 and decide whether to uphold some or all of Kacsmaryk’s injunctions, potentially banning or restricting mifepristone again.

After the court ruled, the losing party could petition all 5th Circuit justices for rehearing, known as en banc rehearing, and also petition the Supreme Court a second time.

WHEN WILL THE CASE FINALLY BE DECIDED?

Once all appeals against the preliminary injunction are concluded, the case can proceed to trial on the merits before Kacsmaryk, giving both parties an opportunity to present evidence. This could include evidence about the process the FDA uses for approving mifepristone and the drug’s safety.

Kacsmaryk could then decide the case without trial, known as a summary judgment, or hold a trial including witness testimony.

Kacsmaryk’s final judgment could take months or even years. Once there, the losing side will again have the option to appeal to the 5th Circuit and possibly the Supreme Court.

(Reporting by Brendan Pierson in New York, editing by Alexia Garamfalvi, Bill Berkrot and Leslie Adler)

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