The Department of Justice filed an emergency request on Friday asking the Supreme Court justices to put on hold a ruling by US District Judge Matthew Kacsmaryk in Texas.

That decision would significantly restrict the distribution of mifepristone while litigation in the challenge by anti-abortion rights groups to the pill’s regulatory approval proceeds.

Danco Laboratories, the manufacturer of mifepristone, also asked the US Supreme Court for similar relief on Friday.

“The resulting disruption would deny women lawful access to a drug [the US Food and Drug Administration] deemed a safe and effective alternative to invasive surgical abortion,” the Department of Justice wrote in its filing (PDF).

Kacsmaryk’s order – a preliminary injunction – was set to take effect at 12am CDT (05:00 GMT) on Saturday, according to the department.

In a case that could also undercut the US Food and Drug Administration’s authority to decide on the safety of drugs, the New Orleans-based 5th US Circuit Court of Appeals on Wednesday declined the administration’s request to block the restrictions ordered by Kacsmaryk on April 7.

The 5th Circuit halted another part of Kacsmaryk’s order that would have suspended the FDA’s approval of the drug, effectively pulling it off the market.

The lower courts’ orders could have “sweeping consequences for the pharmaceutical industry, women who need access to the drug, and FDA’s ability to implement its statutory authority”, the Department of Justice said on Friday.

Abortion battles

The battle over mifepristone has come nearly a year after the US Supreme Court, which has a conservative majority, overturned a landmark 1973 abortion ruling that had guaranteed the constitutional right to abortion in the US.

Since the overturning of Roe v Wade, Republican-led states across the country have quickly moved to impose severe restrictions or outright bans on the procedure.

Mifepristone, which was approved by the FDA in 2000, is used in combination with another drug called misoprostol to perform medication abortion, which accounts for more than half of all US abortions.

The restrictions set by the lower courts would restore curbs on the medication that had been lifted since 2016 as the FDA steadily expanded access.

These revived restrictions include a requirement for three in-person doctor visits in order to obtain mefipristone and limiting its use to the first seven weeks of pregnancy, down from the current 10.

Attorney General Merrick Garland said on Thursday that the 5th Circuit did not go far enough to “protect Americans’ access to safe and effective reproductive care”.

Adding to the uncertainty, a separate federal judge in Washington state that same day clarified his own order from last week to make clear that the FDA is not to do anything that might block mifepristone’s availability in 17 Democrat-led states suing to keep it on the market.

It is unclear how the FDA can comply with court orders in both cases.

Danco Laboratories said Friday it may have to halt operation if the Supreme Court does not lift the lower court limits on distribution.

‘Far beyond abortion’

Meanwhile, the American Civil Liberties Union (ACLU) said this week that if the 5th Circuit appeals court’s decision is allowed to stand, it “will dramatically affect our access to medication abortion”.

“The implications of this decision also go far beyond abortion — they could deny people access to other critical, life-saving drugs,” the group wrote on Twitter. “It’s a loss for all who need to access abortion care, and critical life-saving drugs.”

The Texas lawsuit was filed by the Alliance Defending Freedom, a conservative legal group that also argued to overturn Roe v Wade, and is representing doctors and medical organisations opposed to abortion rights.

ADF lawyers said on Thursday that they did not plan to seek an appeal that might restore the Texas court’s full ruling at this point.

“The 5th Circuit’s decision is a significant victory for the doctors we represent, women’s health, and every American who deserves an accountable federal government acting within the bounds of the law,” said Erin Hawley, a lawyer for the group.

The challengers to mifepristone have called the new limits critical safeguards to a medication they consider dangerous.

The implications of this decision also go far beyond abortion — they could deny people access to other critical, life-saving drugs.

Last night’s ruling ignores both the law and science. It’s a loss for all who need to access abortion care, and critical life-saving drugs.

— ACLU (@ACLU) April 13, 2023

The Department of Justice has said the challengers have no basis for second-guessing the FDA’s scientific judgement and that when used as directed, adverse effects of mifepristone are exceedingly rare “just as they are for many common drugs like ibuprofen”.

More than 5.6 million people in the US had used the drug as of June 2022, according to the FDA.

In that period, the agency received 4,200 reports of complications in women, or less than one-tenth of 1 percent of women who took the drug.