In the most recent contentious legal dispute regarding reproductive rights in the United States, the Supreme Court on April 21 reversed new constraints placed on a common abortion pill, giving President Joe Biden's administration a win while defending the drug's open accessibility.
"As a result of the Supreme Court's stay, mifepristone remains available and approved for safe and effective use while we continue this fight in the courts," says President Joe Biden in a statement delivered by the White House.
Mifepristone was authorized in 2000 by the Food and Drug Administration (FDA), a federal agency responsible for determining the safety of drugs and medicines. But in early April 2023, a conservative Texas court issued an injunction forbidding the sale of mifepristone beginning on April 7.
"The only medication at issue in this litigation is Mifepristone, which is one drug in a two-drug protocol for abortion care within the physician-patient relationship. This medication, combined with Misoprostol, is used at the direction of a physician to support a pregnant person’s decision to terminate a pregnancy consistent with FDA regulations. A patient ingests Mifepristone to block the hormones necessary for pregnancy development. The patient then takes Misoprostol thereafter to shed the uterine contents and end the pregnancy," shares Jamie R. Abrams from American University.
Mifepristone is one of two abortion pills used in medication abortions, which account for more than half of pregnancies terminated in the U.S. A lawsuit was brought by a number of conservative groups disputing whether the FDA followed the right processes and took scientific data into account.
While this decision is not a forward-looking victory for women’s health, it allows Mifepristone to remain legally accessible to the degree it was before one judge in the Northern District of Texas unilaterally overrode the long-established federal drug approval process. This decision is really a procedural one letting the ordinary process play out at the lower court, not a substantive one. This opinion shifts the focus back to the Fifth Circuit. The ruling does not provide analyses or rationales from which to speculate regarding what’s next at the Supreme Court. Justice Alito, however, does dissent from letting the ordinary appellate process payout. This is a worrisome – although not surprising – reality when considering that Alito insisted in Dobbs that the Court was overturning Roe because it short-circuited the democratic process.- Jamie R. Abrams
Abrams continues that, as of now, the decision will "preserve the availability of medication abortion consistent with FDA oversight."
The organizations claim that the drug should never have been made available to American consumers as it is hazardous. Based on two decades' worth of accumulated scientific data, prominent medical institutions vigorously contest these statements. In the lawsuit, it is demanded that the FDA rescind its approval of mifepristone, removing it from U.S. pharmacy shelves.
The Justice Department, independent health advocates, and pharmaceutical companies have all aggressively opposed the case, claiming that it would establish a dangerous precedent for a court to interfere with the FDA's regulatory authority despite mifepristone being safe.
Roe v Wade, the 1973 Supreme Court case which says the government was forbidden from banning abortion, was overturned in June 2022, limiting many states' abortion rights.
The stakes could not be higher for women across America. I will continue to fight politically-driven attacks on women’s health. But let’s be clear – the American people must continue to use their vote as their voice and elect a Congress who will pass a law restoring the protections of Roe v Wade.- President Joe Biden
Conservative groups initially filed the lawsuit in Amarillo, Texas, before Trump nominee and U.S. District Judge Matthew J. Kacsmaryk, who has strong anti-abortion views. Kacsmaryk ruled in favor of the NGOs and ordered the FDA to revoke its approval of mifepristone.
In anticipation of the outcome of the Biden administration's appeal to the U.S. Court of Appeals for the Fifth Circuit, the Kacsmaryk ruling was put on hold.
The Fifth Circuit denied Kacsmaryk's effort to have the FDA rescind its clearance of the drug, despite the Biden administration's urging that public access to mifepristone be protected. Instead, it severely limited the drug's accessibility and application. Among them are the drug's existing ten-week usage limit being shortened to seven weeks and its inability to be ordered by mail or distributed by anybody other than doctors with a prescription.
Following an appeal of the Kacsmaryk ruling, the Biden administration asked the Supreme Court to put the ruling on hold and restore full access to the drug.
The decision was supposed to arrive by 11:59 pm on Wednesday but was postponed by Justice Samuel Alito. With no further explanation, the court announced they would make a decision before midnight on April 21.
- White House. Statement from President Joe Biden on the Supreme Court’s Decision in Alliance for Hippocratic Medicine v. FDA
- The Guardian. US supreme court expected to rule on abortion pill access lawsuit – live
- FDA. Questions and Answers on Mifepristone for Medical Termination of Pregnancy Through Ten Weeks Gestation