Supreme Court allows abortion pill to remain on market for now; Alito dissents
The U.S. Supreme Court will temporarily allow the abortion pill to stay on the market until appeals against a Texas federal judge's suspension of the Food and Drug Administration approval of the drug can be adjudicated.
In an unsigned ruling Friday night, the court granted the request by the FDA and the abortion pill's manufacturer Danco Laboratories for a stay of Trump-appointed Judge Matthew Kacsmaryk's April 7 suspension of the FDA's 2000 approval of mifepristone pending disposition of the appeal in the U.S. 5th Circuit Court of Appeals and petition for a writ of certiorari for review by the nation's high court. The 5th Circuit will hear oral arguments in the case next month.
Mifepristone is the first drug in the chemical abortion regimen, which destroys the environment in the uterus and starves an unborn baby to death. Also known as chemical abortion or the abortion pill, mifepristone has emerged as a source of safety concerns for the pro-life movement. Chemical abortions represent about half of all abortions in the United States.
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Two justices, Clarence Thomas and Samuel Alito, indicated they would have denied the requests.
In dissent, Justice Samuel Alito accused the court of "shadow-docket decisionmaking," suggesting that the appellants "are not entitled to a stay because they have not shown that they are likely to suffer irreparable harm in the interim."
"The applicants claim that regulatory 'chaos' would occur due to an alleged conflict between the relief awarded in these cases and the relief provided by a decision of the United States District Court for the Eastern District of Washington," he wrote. "It is not clear that
there actually is a conflict because the relief in these cases is a stay, not an injunction, but even if there is a conflict, that should not be given any weight."
On the same day as Kacsmaryk's ruling, Judge Thomas Rice in Washington, an Obama appointee, issued a preliminary injunction prohibiting the FDA from "altering the status quo and rights as it relates to the availability of mifepristone." His ruling came after 17 states and Washington, D.C., asked the court to prevent the FDA from "reducing mifepristone's availability." The plaintiffs argued that it is "fair and equitable for FDA to not act with respect to the Mifepristone REMS Program until a determination is made on the merits."
Alito contends that the Supreme Court should not issue a say "if the moving party has not acted equitably, and that is the situation here."
"The Food and Drug Administration (FDA) has engaged in what has become the practice of 'leverag[ing]' district court injunctions 'as a basis' for implementing a desired policy while evading both necessary agency procedures and judicial review," he wrote.
"The Washington District Court enjoined the FDA from altering its current practice regarding mifepristone — something that the FDA had never hinted it was contemplating. 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."
Alito continued by saying that the applicant's argument for "irreparable harm" is primarily based on the claim "Danco could not continue to market mifepristone because the drug would be mislabeled" and "distribution could not resume until Danco jumped through a series of regulatory steps that would be largely perfunctory under present circumstances."
"That would not take place, however, unless the FDA elected to use its enforcement discretion to stop Danco, and the applicants' papers do not provide any reason to believe the FDA would make that choice," he wrote.
Jason Yates, CEO of My Faith Votes, expressed disappointment with the court's temporary stay.
"Our hearts break to consider how many more innocent human lives will be ended," responded Jason Yates of My Faith Votes.
"The fact remains that the FDA approved the drug in defiance of science and standard safety protocol in service of Big Abortion and political interests. While disappointed in this decision, we take solace tonight knowing the underlying lawsuit will eventually receive a full review by the Supreme Court Justices, and we trust that this evil drug will ultimately be off the market."
NARAL Pro-Choice America President Mini Timmaraju said in a statement praising the order that its "crucial" for people to have access to chemical abortion pills.
"The fight, however, is far from over," Timmaraju said. "Once again, anti-abortion extremists will use the courts to push their deeply unpopular agenda and once again, we will organize the tens of millions of people who believe in safe, legal abortion to fight back."
Carol Tobias, president of National Right to Life, said that her organization hopes that the 5th Circuit will "confirm the fact that these drugs are dangerous to women."
"The U.S. Supreme Court gives the full 5th Circuit the opportunity to evaluate the case on its merits and review the materials presented to them in a timely fashion," said Tobias. "What the courts will see is a drug that does not cure a disease or alleviate the symptoms of a disease. It was developed to take the life of an unborn child and always has the potential to harm the mother."
The FDA-approved chemical abortion regimen consists of a two-drug combination of mifepristone and misoprostol. After the FDA eased longstanding restrictions in recent years, women can use the drugs for chemical abortion up to 10 weeks gestation, previously limited to seven weeks. The pills can now be prescribed following a telemedicine consultation without requiring an in-person appointment with a healthcare provider, which critics warn could put the health of women with ectopic pregnancies at risk.
Alito asserted that if the Supreme Court rejected a request for a stay, it would "not eliminate mifepristone from the market" but would have stayed the 5th Circuit's decision to allow the lower court's block on the distribution of the pill by mail and other restrictions to go into effect.
The Alliance for Hippocratic Medicine, the American Association of Pro-Life Obstetricians & Gynecologists, the Christian Medical & Dental Associations and four individual doctors filed a lawsuit seeking an overturning of the FDA's 2000 approval of mifepristone and the Biden administration's more recent lifting of restrictions, such as allowing the drug to be distributed by mail.
While proponents of easing restrictions on the abortion pill argue that data shows the drug is relatively safe compared to other approved drugs, the 5th Circuit panel earlier this month ruled that the FDA "failed to 'examine the relevant data' when it made the 2016 major [Risk Evaluation and Mitigation Strategies] changes."
"That's because FDA eliminated REMS safeguards based on studies that included those very safeguards," the 5th Circuit ruling states. "Imagine that an agency compiles studies about how cars perform when they have passive restraint systems, like automatic seatbelts. For nearly a decade, the agency collects those studies and continues studying how cars perform with passive safety measures. Then one day the agency changes its mind and eliminates passive safety measures based only on existing data of how cars perform with passive safety measures."
The ruling included a picture of a "Black Box" warning on mifepristone that informs users that it can cause "serious and sometimes fatal infections or bleeding," including the possibility of "prolonged heavy bleeding." Additional potential side effects listed on the "Black Box" warning include "sustained fever, severe abdominal pain" as well as "abdominal pain or discomfort, or general malaise (including weakness, nausea, vomiting or diarrhea)."
