Global Courant 2023-04-19 00:08:13
Anti-abortion groups have filed a complaint urging the United States Supreme Court to limit the availability of the abortion pill mifepristone, challenging the drug’s federal approval and asking judges to enforce curbs ordered by a conservative judge in Texas.
On Tuesday, the challengers called on the Supreme Court to deny emergency requests from the administration of Democratic President Joe Biden and the pill maker to stop U.S. District Judge Matthew Kacsmaryk’s preliminary injunction on April 7.
That order, issued by a federal court in Amarillo, Texas, would significantly limit the distribution of mifepristone as the lawsuit continues.
In a ruling on April 12, the New Orleans-based Fifth U.S. Circuit Court of Appeals refused to block certain restrictions, but stopped part of Kacsmaryk’s order that would have suspended the drug’s approval by the U.S. Food and Drug Administration (FDA). take it off the market.
The FDA is the US agency that signs the safety of foods, drugs and medical devices. It approved mifepristone in 2000.
“The only effect of the lower court order is to restore a measure of safety to the women and girls taking the drug, including supervision and supervision by a physician,” said lawyers for the Alliance Defending Freedom, a conservative group. for religious rights that the pill represents. challengers, wrote in the submission.
The FDA and mifepristone maker Danco Laboratories have ignored “holes and red flags” in their safety data for years, “showing callous disregard for women’s welfare, unborn life and legal limits,” the lawyers said.
The FDA maintains that mifepristone is safe and effective, a record it says has been conclusively proven over decades of use by millions of Americans. Side effects from mifepristone are exceedingly rare, it says.
The case poses another major threat to abortion rights in the US, following the Supreme Court’s decision last June to overturn the groundbreaking 1973 Roe v Wade ruling that had legalized the procedure nationwide. Since then, more and more abortion bans and restrictions have been enacted by Republican-led states.
Mifepristone is taken with another drug called misoprostol to perform drug-induced abortion, which now accounts for more than half of all U.S. abortions.
Conservative Judge Samuel Alito, author of the June ruling, temporarily blocked restrictions on mifepristone last Friday to give the Supreme Court time to weigh the administration’s and Danco’s requests, along with the challengers’ arguments. The Supreme Court has a conservative majority of 6 to 3.
Alito, which handles emergencies that arise in a group of states, including Texas, has postponed the entry into force of the restrictions until 11:59 p.m. ET (03:59 GMT) on Wednesday. The court is expected to issue another injunction on the mifepristone case by then.
The case could undermine the federal regulatory authority over drug safety. The Biden administration and Danco said on Friday that mifepristone may not be available for months when restrictions go into effect.
Kacsmaryk’s decision violated an order also issued April 7 in a separate Washington state case directing the FDA to keep mifepristone available in 17 states and the District of Columbia.
The two rulings raise questions about how the FDA would handle conflicting judicial orders if the Supreme Court denies the government’s request for relief.
Anti-abortion groups led by the recently formed Alliance for Hippocratic Medicine and four anti-abortion doctors sued the FDA in November to overturn mifepristone’s approval.
Lower court restrictions would reinstate curbs on mifepristone that had been lifted since 2016 when the FDA steadily expanded access. These restrictions include a requirement of three in-person doctor visits to obtain mifepristone and would limit its use to the first seven weeks of pregnancy, rather than the current 10.
Since last year’s Supreme Court ruling, 12 US states have completely banned abortion, while many others have banned 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 banning most abortions after six weeks of pregnancy.
