The US Supreme Court is seen in Washington, DC on May 25, 2023

The Supreme Court upholds the validity of the abortion medication mifepristone, so permitting its continued sale

In a decision that will keep the abortion pill mifepristone available for mail order, the Supreme Court on Thursday dismissed a lawsuit contesting the Food and Drug Administration’s method of policing the medication.

In the first substantial issue involving reproductive rights to reach the Supreme Court since the conservative majority overturned Roe v. Wade in 2022, the decision represents a huge blow for the anti-abortion movement.

Justice Brett Kavanaugh wrote the opinion for a unanimous court.

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The physicians and anti-abortion organizations who had contested the drug’s availability were found not to have the legal standing to file a lawsuit. The court’s rationale, while technical, is significant because it may pave the way for other mifepristone challenges in the road.

“We acknowledge that a significant number of individuals, including the plaintiff physicians present, hold genuine apprehensions and disapprovals towards others utilizing mifepristone and undergoing abortions,” wrote Kavanaugh. “However, the mere fact that others are permitted to partake in a particular activity does not give citizens and doctors the right to sue—at least not unless the plaintiffs can show how their interests would be harmed by the government’s purported underregulation of others.”

The pharmaceutical industry fiercely opposed the drug’s challenge, stating that a decision that called into question the legality of mifepristone’s rules could pave the way for legal challenges aimed at other drugs.

“A plaintiff’s desire to make a drug less available for others does not establish standing to sue,” Kavanaugh said, citing the Constitution.

“Doctors and citizens who disagree with what the law permits others to do can always bring their concerns to the attention of the Executive and Legislative Branches and seek stronger legislative or regulatory limitations on specific activities,” the author stated.

Kavanaugh’s judgment mostly addressed the different legal standards that a plaintiff must meet in order for the courts to properly become involved in a dispute. Referring to the medical associations and anti-abortion doctors who had sued the federal government over the drug’s present regulatory framework, Kavanaugh wrote that the plaintiffs had not sustained the kind of physical or financial harm necessary to establish standing. He pointed out that individual medical professionals who are morally opposed to providing abortions are already protected by federal law.

“To put it succinctly, the plaintiffs have not demonstrated — and cannot demonstrate — that the FDA’s actions will cause them to suffer any conscience injury, given the broad and comprehensive conscience protections guaranteed by federal law,” Kavanaugh said.

In his concurrence, Justice Clarence Thomas raised additional concerns he had with the standing claims of the anti-abortion organizations.

The Justice Department refrained from commenting on the decision right away, as it was defending the abortion pill’s present regulations. Manufacturer of mifepristone Danco expressed its satisfaction with the Supreme Court’s ruling in this crucial case. Danco had intervened to support medicine access as well.

The decision “maintained the stability of the FDA drug approval process, which is based on the agency’s expertise and on which patients, healthcare providers, and the US pharmaceutical industry rely,” according to Danco spokesperson Abigail Long.

According to Long’s statement, “the decision also safeguards access to a drug that has decades of safe and effective use.”

The anti-abortion doctors’ legal group, Alliance Defending Freedom, expressed disappointment that the Supreme Court did not address the FDA’s unlawful removal of reasonable safety standards for abortion drugs. However, the group hinted that additional plaintiffs may join the legal battle for the regulations.

One of the medical groups challenging the FDA is Ingrid Skop, an OB-GYN who opposes abortion. She expressed her disappointment that the FDA was not held responsible for its careless judgments today.

Originated in Texas with Trump-appointed judge

The FDA regulations were initially contested by anti-abortion doctors and medical groups, who claimed mifepristone was dangerous and should be taken off the market. However, major medical organizations have since disputed these claims.

The conservative state legislation that drastically restricted abortion over a large portion of the nation served as a backdrop for that endeavor. Mifepristone was a natural target for the anti-abortion movement because those bans contributed to the rise in the demand for pharmaceutical abortion. Some estimates place the number of medication abortions performed in the US at close to two thirds of all abortions.

Matthew Kacsmaryk, a federal judge nominated by former President Donald Trump to the United States, sided with anti-abortion organizations; however, his ruling was never implemented.

The drug’s underlying two-decade-old approval would remain in place, according to the 5th US Circuit Court of Appeals, which overturned part of that decision. However, the appeals court took the side of the physicians who contested later agency rulings that increased access to the medication, including the capacity to prescribe it via mail.

The Supreme Court intervened last year and ordered that the mifepristone status quo remain in place until the justices considered the case, so none of those lower court orders came into force. Arguments were heard by the Supreme Court in March.

While this was going on, a number of states run by Republicans entered the case at the trial court level, indicating that the legal battle over access to abortion pills may not end even if the Supreme Court denied the anti-abortion doctors’ complaint.

Referring to the initiatives of those Republican states, Steve Vladeck, a professor at the University of Texas School of Law and CNN Supreme Court commentator, stated that Thursday’s decision “doesn’t cut off the potential of future challenges against mifepristone.”

“The rationale behind the case should lessen the likelihood of those challenges succeeding, as it will be difficult for those plaintiffs and others to demonstrate that they suffered harm as a result of the FDA’s actions,” Vladeck stated.

Mifepristone was approved by the FDA in 2000 as a component of a two-drug combination to stop a pregnancy. The agency relaxed the initial restrictions on the drug’s use during a 20-year period. In 2016, the medication was made available to women who were seven weeks along in their pregnancies and beyond. It also made it possible for non-medical professionals to prescribe it, such nurse practitioners. The FDA declared that it will no longer enforce the rule for in-person dispensing during the Covid-19 pandemic.

The FDA formally made that decision last year, following the filing of the doctors’ complaint, enabling the medication to be sent out by mail.

The FDA informed the Supreme Court that mifepristone is safe, as did a number of medical associations, including the American Medical Association.

However, the physicians, many of whom have a history of being connected to the anti-abortion movement, asserted that they ran the danger of having to treat patients who had drug-related side effects, like heavier-than-expected bleeding. They asserted that their procedures were significantly impacted by the women’s triaging. In addition, others said they had been asked to carry out post-medication abortion procedures, which went against their religious convictions.

During the Supreme Court hearing earlier this year, a number of justices, notably those from the conservative bloc, voiced skepticism about the doctors’ ability to meet the standing requirement, which calls on plaintiffs to demonstrate that their activities had caused them injury.

The Alliance for Hippocratic Medicine, the primary medical group involved in the complaint, was incorporated in Amarillo, Texas, some months before to filing the lawsuit. This gave them the option to select a court where Kacsmaryk, a former President Donald Trump appointee, would undoubtedly be assigned.

The Biden administration contended that since the anti-abortion doctors were not writing prescriptions for the medication, it was inappropriate for them to contest the rules, in conjunction with a mifepristone producer who intervened on behalf of the FDA.

The ruling came at a time when the Supreme Court’s abortion precedent was already having a significant impact on the outcome of the presidential race. The Dobbs v. Jackson Women’s Health Organization decision in 2022 put an end to the Roe v. Wade constitutional right to an abortion, which was established in 1973. As a result of the ruling, conservative states tightened restrictions on the process, sparking more legal action and assisting Democrats in organizing. Throughout the campaign trail this year, President Joe Biden has criticized the choice numerous times.

This month, the Supreme Court was deliberating over two abortion issues, one of which was the appeal of mifepristone. The other addresses Idaho’s stringent prohibition on the technique. In response, the Biden administration filed a lawsuit against the state, claiming that a federal statute mandates that hospitals receiving Medicare funds perform stabilization care in emergency departments, including abortions, when the health of the expectant mother is in jeopardy.

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