Packages of Mifepristone tablets are displayed at a family planning clinic on April 13, 2023 in Rockville, Maryland. A Massachusetts appeals court temporarily blocked a Texas-based federal judge’s ruling that suspended the FDA’s approval of the abortion drug Mifepristone, which is part of a two-drug regimen to induce an abortion in the first trimester of pregnancy in combination with the drug Misoprostol. (Anna Moneymaker/Getty Images)
WASHINGTON — The abortion pill will remain available throughout the United States while a lawsuit over its approval and use works through the appeals process, the U.S. Supreme Court said Friday.
The court issued a stay that ensures access to mifepristone nationwide, reversing lower court rulings about when and how the abortion medication should be available in a case filed by anti-abortion organizations. The case is expected to ultimately be decided by the high court following appeals court deliberations.
Friday’s decision stems from a ruling in the U.S. District Court for the Northern District of Texas, where Judge Matthew Kacsmaryk, in early April, essentially overturned the U.S. Food and Drug Administration’s approval of mifepristone dating back to 2000. Kacsmaryk is a nominee of former President Donald Trump.
The 5th Circuit Court of Appeals in New Orleans then placed a partial hold on the district court ruling, following a request from the U.S. Department of Justice.
The ruling by that three-judge panel would have kept mifepristone on the market, but required use and administration of mifepristone to revert to the FDA’s pre-2016 instructions.
Mifepristone, which blocks a hormone called progesterone that is needed for a pregnancy to continue, is one of two drugs used in a medication abortion. Medical abortions make up more than half of abortions in the U.S., according to research by the Guttmacher Institute.
Friday’s highly anticipated ruling by the high court means the abortion pill will remain on the market for now without the limitations placed on it by the appeals court.
“The April 7, 2023, order of the United States District Court for the Northern District of Texas, case No. 2:22–cv–223, is stayed pending disposition of the appeal in the United States Court of Appeals for the Fifth Circuit,” read the opinion, issued just before 7 p.m. Eastern on Friday.
Dissents from Thomas, Alito
The only noted dissents were from Justices Clarence Thomas and Samuel Alito. Alito wrote that he would not have granted the stay for the lower court decision, arguing that the 5th Circuit Court of Appeals placed the suit on a “fast track.”
“(T)here is reason to believe that they would get the relief they now seek — from either the Court of Appeals or this Court — in the near future if their arguments on the merits are persuasive,” Alito wrote.
In a statement, President Joe Biden said the stay granted by the Supreme Court prevented a lower court from undermining the “FDA’s medical judgment and put women’s health at risk.”
“I continue to stand by FDA’s evidence-based approval of mifepristone, and my Administration will continue to defend FDA’s independent, expert authority to review, approve, and regulate a wide range of prescription drugs,” he said.
In his dissent, Alito argued that the Justice Department did not prove “that they are likely to suffer irreparable harm.”
Regarding a separate, contrary ruling issued by a federal judge in Washington state that preserves full access to the abortion pill in more than a dozen states, Alito said the argument that “chaos” could ensue from the opposite decisions “should not be given any weight.”
That separate case pertaining to access to mifepristone that contradicts the Texas decision came from 17 Democratic state attorneys general — and the District of Columbia — who filed a suit, arguing that the FDA wrongly imposed restrictions on mifepristone. Shortly after the Texas judge’s decision, Washington state judge Thomas Rice, an appointee of former President Barack Obama, ordered the FDA to preserve the status quo for mifepristone for those 17 states and the District of Columbia.
“The Washington District Court enjoined the FDA from altering its current practice regarding mifepristone — something that the FDA had never hinted it was contemplating,” Alito wrote. “The FDA did not appeal that appealable order, and when seven States that might take such an appeal asked to intervene, the FDA opposed their request. This series of events laid the foundation for the Government’s regulatory ‘chaos’ argument.”
Reactions pour in
Following the Friday stay, congressional Democrats acknowledged that the decision to keep mifepristone on the market is a short reprieve.
Senate Majority Leader Chuck Schumer, a New York Democrat, said in a statement that the Supreme Court’s stay is “a temporary victory.”
“Make no mistake, extreme MAGA Republicans will continue to pursue their nationwide abortion ban until they impose their anti-choice agenda on all Americans,” he said.
The co-chair of the House Pro-Choice Caucus, Democratic Rep. Diana DeGette of Colorado, said in a statement that the stay “averted a disaster that not only would have put women’s health at risk, but also threatened to upend our nation’s entire drug-approval process going forward.”
“As the 5th Circuit now prepares to consider this case, I’m hopeful any future decisions regarding Americans’ ability to access this important medication are based solely on science, not politics,” she said.
Alliance Defending Freedom, the organization representing the plaintiffs, maintains the FDA approved the drug without safeguards, despite numerous studies showing the drug’s safety and effectiveness.
“As is common practice, the Supreme Court has decided to maintain the status quo that existed prior to our lawsuit while our challenge to the FDA’s illegal approval of chemical abortion drugs and its removal of critical safeguards for those drugs moves forward,” said the organization’s senior counsel, Erik Baptist, in a statement Friday night.
“Our case seeking to put women’s health above politics continues on an expedited basis in the lower courts. … We look forward to a final outcome in this case that will hold the FDA accountable,” the statement continued.
The 5th Circuit ruling, which will no longer go into effect, was unworkable, said the federal government, the manufacturers of the brand name and generic versions of the drug, and reproductive rights organizations.
It would have meant that mifepristone would no longer have been approved for up to 10 weeks gestation, but seven weeks.
Patients would have to attend three in-person doctor visits instead of one, all adverse events would have to be reported to the FDA, and dosage and administration of the medication would have reverted to pre-2016 instructions.
It would have prevented doctors from prescribing mifepristone via telehealth and prohibited delivery of the medication through the mail.
The generic version of mifepristone would no longer have been approved.
Oral arguments in the appeals court are scheduled for mid-May.
Ariana Figueroa contributed to this report.
Our stories may be republished online or in print under Creative Commons license CC BY-NC-ND 4.0. We ask that you edit only for style or to shorten, provide proper attribution and link to our web site. Please see our republishing guidelines for use of photos and graphics.