A patient prepares to take the first of two combination pills, mifepristone, for a medical abortion during a 2024 visit to a clinic in Kansas City, Kansas (AP Photo)
The Supreme Court said on Friday that it will temporarily maintain federal rules for the use of an abortion drug while it takes time to fully consider the issues raised in a lawsuit. In an order signed by Judge Samuel Alito, the court halted five days for the fast-moving case so that the justices could decide whether to allow trial court rulings restricting FDA approval of mifepristone. short term effect. Judges at this point are only required to determine which parts of the April 7 ruling by US District Judge Matthew Kaksmarek in Texas, as amended by Wednesday’s appellate ruling, could be in effect while the case continues. The order expires as late as Wednesday, suggesting the court will rule on the matter by then. The court finds itself embroiled in a new battle involving abortion less than a year after conservative justices overturned Roe v. Wade and allowed more than a dozen states to ban abortion outright. President Joe Biden’s administration and New York-based Danco Laboratories, the maker of the pills, have asked the judges to step in. White House press secretary Karen Jean-Pierre said in a statement Friday night that the administration is continuing “To stand by evidence-based FDA approval of mifepristone, we will continue to support the FDA’s independent expert authority for the review, approval and regulation of a broad range of prescription drugs.”
she added, “The stakes of this fight could not be higher in the face of the continued attacks on women’s health, and we will continue to fight to restore Roe v. Wade protection.”
An attorney for anti-abortion doctors and the medical organizations suing the drug mifepristone said Friday’s court action was standard operating procedures He urged the justices to allow the changes ordered by the appeals court to take effect by the middle of next week. The type of order the court issued on Friday, an administrative stay, is not usually an indication of what the justices will do in the future. It is signed by Alito as it handles emergency deposits from Texas. Alito is also the author of last year’s opinion that overturned Roe v. Wade. The Ministry of Justice and Danko warned of “organizational chaos” And harm to women if the Supreme Court does not block lower court decisions that had the effect of toughening the Food and Drug Administration’s rules under which the drug, mifepristone, can be prescribed and dispensed with. The new limits were in effect on Saturday if the court took no action.
“This application relates to unprecedented lower court orders overturning the FDA’s scientific judgment and unleashing regulatory chaos by suspending the FDA-approved terms of use for mifepristone.” Solicitor General Elizabeth Prilogar, the chief Supreme Court attorney in the Biden administration, wrote Friday, less than two days after the appeal ruling. The Biden and Danko administrations now want a more permanent system that would keep the existing rules in place as long as the legal fight over mifepristone continues. As a precaution, they have asked the court to take up the case, hear the arguments and make a decision by early summer on the legal challenge to Mifepristone that was filed by anti-abortion doctors and medical organizations last year. Rarely does a court act so quickly to grant a full review of cases before at least one appeals court has thoroughly examined the legal issues involved. A ruling by the 5th US Court of Appeals late Wednesday would prevent birth control pills, used in the most common method of abortion, from being mailed or prescribed without a doctor’s in-person visit. It would also withdraw FDA approval for the use of mifepristone after the seventh week of pregnancy. The FDA says it is safe within 10 weeks. However, the appeals court has not completely withdrawn the FDA’s approval of mifepristone while the fight over it continues. The Fifth Circuit narrowed down an April 7 ruling by U.S. District Judge Matthew Kacsmarek whose far-reaching and almost unprecedented order blocked the FDA’s approval of the birth control pill. He gave the administration one week to appeal.
“As far as the government is aware, this is the first time any court has overturned the FDA’s conditions for approval of a drug based on a disagreement with the agency’s ruling on safety — let alone done so after those conditions had been in place for years,” Prelogar Books. Erin Holley, an attorney for the competitors, said in a statement that the FDA has put policy ahead of health concerns in its procedures for medical abortion.
“The Fifth Circuit rightly asked the agency to prioritize women’s health by restoring critical safeguards, and we will urge the Supreme Court to keep that accountability in place.” said Holley, a senior counsel for Alliance Defending Freedom, a conservative legal group that also argued for Roe v. Wade to be overturned. Mifepristone was approved by the Food and Drug Administration more than two decades ago, and is used in combination with a second drug, misoprostol. Adding to the uncertainty, a separate federal judge in Washington on Thursday clarified his own order from last week to make clear that the Food and Drug Administration wouldn’t do anything that might block the availability of mifepristone in 17 states led by Democrats to keep it on the market. It’s unclear how the Food and Drug Administration (FDA) can comply with court orders in either case, a situation that Prilogar on Friday called untenable. The use of medical abortion jumped dramatically after the FDA’s 2016 rule expansion, according to data collected by the Guttmacher Institute, a research group that supports abortion rights. In 2017, medical abortion accounted for 39% of all abortions, but by 2020 it has increased to be the most common method, accounting for 53% of all abortions. Experts said the use of chemical abortions has increased since the court overturned Roe. When the drug was initially approved, the FDA limited its use to up to seven weeks of pregnancy. It also required three in-person office visits: the first to administer mifepristone, the first to administer the second drug, misoprostol, and the third to address any complications. It also required a physician’s supervision and reporting system for any serious drug consequences. If the Court of Appeal proceeding proceeds, these will again be the conditions under which mifepristone can be dispensed with for the time being. The crux of the Texas lawsuit is the claim that the FDA’s initial approval of mifepristone was flawed because the agency did not adequately review safety risks. Mifepristone has been used by millions of women over the past 23 years. While less draconian than revoking a drug’s approval entirely, the latest ruling still represents a stark challenge to the Food and Drug Administration’s (FDA) authority that oversees how prescription drugs are used in the United States. Common side effects of mifepristone include cramping, bleeding, nausea, headache, and diarrhea. In rare cases, women can experience excessive bleeding that requires stopping surgery. However, regulators cited the FDA as easing restrictions on mifepristone “Extremely low rates of serious adverse events.”
More than 5.6 million women in the United States had used the drug as of June 2024, according to the Food and Drug Administration. In that period, the agency received 4,200 reports of complications in women, or less than a tenth of 1% of women who took the drug.