The Supreme Court will decide on the FDA's approval of the abortion drug mifepristone.

The Supreme Court is set to rule on a contentious appeal regarding nationwide access to abortion, despite its controversial decision to end the constitutional right to the procedure just two years ago.

The federal government's approval process for the drug mifepristone, which is used to terminate pregnancies, is currently being contested. Oral arguments are set for Tuesday, and a ruling is expected in approximately three months, coinciding with the ongoing race for the next president.

The appeal, with significant legal, social, and political consequences, will center on reproductive rights and have a high-stakes outcome following the Court's landmark ruling that overturned Roe v. Wade.

NATIONWIDE IMPACT

Nearly two-thirds of all abortions in the U.S. in 2023 are performed using mifepristone, according to new research from the Guttmacher Institute. Abortion rights groups argue that the drug is safe and that the Supreme Court's decision could harm 40 million women nationwide. However, anti-abortion organizations contend that the U.S. Food and Drug Administration has been promoting a nationwide regime of on-demand abortion for two decades, in violation of several state health and safety laws.

The Supreme Court has granted the FDA permission to maintain control over the drug during the appeals process, which allows for the continuation of telemedicine prescriptions and retail pharmacy dispensing.

"Thomas Dupree, a former top official in the justice department of former President George W. Bush, believes that it was premature to say that the court would completely exit the abortion business. He states that the justices are aware of the election year but it won't influence their decisions."

Nearly two years after the Supreme Court overturned the nationwide constitutional right to abortion, states have been given individual discretion to regulate the procedure, resulting in various issues being presented.

The Court's 5-4 conservative majority ruled that unelected judges would not interfere with the democratic process of legislators and mandate national abortion policy.

APPROVAL PROCESS

Anti-abortion groups have recently challenged the FDA's 2000 approval process for a drug used to terminate early pregnancies, including recent revisions.

The combination of mifepristone and misoprostol is referred to as medication abortion or the "abortion pill." A federal agency revised regulations for mifepristone in 2016, but lower courts found that the agency did not fully consider the potential health risks to women.

The FDA has made several changes to the recommended use of the drug, including reducing the dose, allowing it to be used up to 10 weeks of pregnancy (from seven weeks), approving a generic version, and allowing it to be mailed (eliminating in-person doctor visits).

This month, Walgreens and CVS were certified to provide the abortion drugs under the new regulations.

According to Planet Chronicle research, 21 states allow full access to mifepristone, while 15 states allow restricted access. In contrast, 14 states completely ban abortion, including medication abortion, except for a few exceptions.

The Supreme Court received an appeal from Danco Laboratories regarding the drug's merits.

In recent weeks, numerous advocacy groups, congressional members, and state coalitions have submitted legal briefs in support of various positions.

THE ARGUMENTS

The four national medical associations of anti-abortion doctors, linked to the conservative advocacy group Alliance Defending Freedom, led the plaintiffs in a lawsuit against the FDA shortly after the Dobbs ruling, which ADF also spearheaded, in an effort to build momentum on further abortion restrictions through litigation.

"Erin Hawley, ADF Senior Counsel, stated that the FDA's removal of original safeguards, such as in-person doctor visits, has resulted in women suffering serious complications alone. She will argue this case before the Court, stating that it is appalling that the FDA would eliminate even the initial in-person visit to check for life-threatening conditions like ectopic pregnancy based on studies they said were not adequate. Women deserve better."

Anti-abortion groups were successful in convincing lower courts that the FDA failed to adequately assess the health risks to women when modifying mifepristone guidelines eight years ago.

The Supreme Court will discuss whether the original 24-year-old approval process for the drugs was similarly flawed under the federal Administrative Procedures Act.

The FDA's authority is being challenged by those who lack the capacity to sue, as they have never prescribed mifepristone. Additionally, the court will assess whether the plaintiffs, who are doctors, would suffer harm from using the drug.

"President Joe Biden stated this month that the stakes are at their highest for women in America due to the ongoing attacks on reproductive freedom by Republican elected officials. Vice President Harris and he will continue to fight to ensure women receive the necessary healthcare, protect the Food and Drug Administration's approval and regulation of mifepristone, and restore Roe v. Wade's protections in federal law."

The FDA's authority to regulate mifepristone is crucial for continued access to abortion, and any ruling limiting this authority could have far-reaching consequences for healthcare.

"The lower court decision's logic, if allowed to stand, would disrupt the pharmaceutical industry and prevent the FDA from fulfilling its duties to the American people. This would be a significant shift in drug testing and market entry, potentially denying individuals access to life-saving medications."

ONGOING CONTROVERSY

The Supreme Court is also facing other abortion issues.

In the upcoming month, the justices will hear oral arguments on a challenge to Idaho's restrictions and whether they violate federal laws mandating hospitals to treat patients in life-threatening crises.

Idaho's Defense of Life Act, which restricts abortions to instances where the mother's life is at risk, was blocked by a federal court due to a conflict with the federal Emergency Medical Treatment and Labor Act. The state's near-total abortion ban imposes criminal penalties on doctors who perform the procedure, except in very limited circumstances.

The Biden administration argues that federal law mandates emergency rooms to offer "stabilizing care," including abortions, for a wider range of situations than just when a mother's life is at risk, such as when a patient's health is in "serious jeopardy."

Other potential court challenges that may arise include the legality of federal Title X funding for abortion referrals and the constitutionality of state bans for those whose religious beliefs support abortion access.

If the Court resolves these disputes, the political consequences could be immediate and significant in the November election. Many progressives, despite criticizing the 2022 Dobbs decision that abolished the federal right to abortion, acknowledged the controversy's ability to galvanize the base and sway undecided voters. The midterm elections yielded better-than-anticipated results for Democrats, while exposing a strategic weakness for Republicans and preventing them from achieving the "red wave" they had hoped for.

The Supreme Court's decision on the abortion pill case in June could have a similar impact, with nine appointed justices in robes set to reignite a divisive referendum on a highly controversial social issue.

The FDA v. Alliance for Hippocratic Medicine cases (23-235) and Danco Laboratories, LLC v. Alliance for Hippocratic Medicine (23-236) involve mifepristone.