Anti-abortion groups have submitted a filing urging the United States Supreme Court to restrict the availability of the abortion pill mifepristone, challenging the medication’s federal approval and asking the justices to implement the curbs ordered by a conservative judge in Texas.
On Tuesday, the challengers called on the Supreme Court to reject emergency requests by Democratic President Joe Biden’s administration and the pill’s manufacturer to halt the preliminary injunction issued on April 7 by US District Judge Matthew Kacsmaryk.
That injunction, issued in a federal court in Amarillo, Texas, would greatly limit mifepristone’s distribution while litigation proceeds.
In a ruling on April 12, the New Orleans-based Fifth US Circuit Court of Appeals declined to block certain restrictions but halted a part of Kacsmaryk’s order that would have suspended approval of the drug by the US Food and Drug Administration (FDA), effectively pulling it off the market.
The FDA is the US agency that signs off on the safety of food products, drugs and medical devices. It approved mifepristone in 2000.
“The only effect of the lower court’s order is to restore a modicum of safety for the women and girls who use the drug, including supervision and oversight by a physician,” lawyers at the Alliance Defending Freedom, a conservative religious rights group representing the pill’s challengers, wrote in the filing.
The FDA and mifepristone maker Danco Laboratories have for years disregarded “holes and red flags” in their safety data, “demonstrating callous disregard for women’s well-being, unborn life and statutory limits”, the lawyers said.
The FDA asserts that mifepristone is safe and effective, a record that it has said is conclusively demonstrated over decades of use by millions of Americans. Adverse effects of mifepristone are exceedingly rare, it says.
The case poses another major threat to abortion rights in the US, after the Supreme Court’s decision last June to overturn the landmark 1973 Roe v Wade ruling that had legalised the procedure nationwide. Mounting abortion bans and restrictions have been enacted by Republican-led states since then.
Mifepristone is taken with another drug called misoprostol to perform medication abortion, which now accounts for more than half of all US abortions.
Conservative Justice Samuel Alito, who authored the June ruling, temporarily blocked the restrictions on mifepristone last Friday in order to give the Supreme Court time to weigh the requests by the administration and Danco, along with the challengers’ arguments. The Supreme Court has a 6-3 conservative majority.
Alito, who handles emergency matters arising in a group of states including Texas, delayed the restrictions from taking effect until 11:59pm ET (03:59 GMT) on Wednesday. The court would be expected to issue another order on the mifepristone case by that time.
The case could undercut federal regulatory authority over drug safety. The Biden administration and Danco said on Friday that mifepristone might not be available for months if the restrictions are allowed to take effect.
“This administration continues to stand by the FDA’s evidence-based approval of mifepristone and the agency’s independent expert authority to review, approve and regulate a wide range of prescription drugs,” White House spokesperson Karine Jean-Pierre told reporters on Tuesday.
“If the district court’s decision or the 5th Circuit’s decision is upheld, it would put women’s health at risk and undermine the FDA’s ability to keep safe and effective medications available for people who need them,” she added. “And it could open the flood gates of attacks against any FDA-approved medication that Americans rely on for care.”
Kacsmaryk’s decision also conflicted with an order also issued April 7 in a separate case from Washington state, directing the FDA to keep mifepristone available in 17 states and the District of Columbia.
The two rulings raise questions over how the FDA would manage contradictory commands from the judiciary if the Supreme Court denies the administration’s bid for relief.
Anti-abortion groups led by the recently formed Alliance for Hippocratic Medicine and four anti-abortion doctors sued the FDA in November seeking to reverse its approval of mifepristone.
The restrictions set by the lower courts would restore curbs on mifepristone that had been lifted since 2016 as the FDA steadily expanded access. These restrictions would include a requirement for three in-person doctor visits to obtain mifepristone and would limit its use to the first seven weeks of pregnancy, down from the current 10.
Since last year’s Supreme Court decision, 12 US states have put in place outright bans on abortion, while many others prohibit the procedure after a certain length of pregnancy. The latest Republican-led move came in Florida, where Governor Ron DeSantis on April 13 signed a new law that bans most abortions after six weeks of pregnancy.
