Supreme Court Contemplates Nationwide Restrictions on Abortion Medication

On Wednesday, the Supreme Court announced that it will review the potential limitations on access to a popular abortion drug, even in states where the procedure is legal. The case in question involves mifepristone, a widely used drug in combination with another for abortions, and is one of the most prevalent methods in the country.

The conservative-leaning court's decision will once again delve into the abortion debate following the overturning of Roe v. Wade last year. This has drastically changed the landscape of abortion rights nationwide, leading to over half of the states outlawing or severely restricting the procedure. The new case may be resolved by July, putting the Supreme Court at the center of the presidential election, with abortion access once again being a crucial issue.

Mifepristone is currently available and not subject to the restrictions ordered by the lower courts. The Supreme Court decided in April that access to the drug would continue until the appeals process is completed. The Biden administration and the drug's manufacturer are urging the justices to overturn a federal appeals court ruling that would limit access to the drug. Conversely, anti-abortion groups and doctors are pushing the justices to rule that the drug's initial approval in 2000 was also unlawful, going even further than the conservative federal appeals court decision.

Behind the challenge

At the heart of the disagreement lies the extent of the US Food and Drug Administration's power to oversee mifepristone, a medication that has been determined to be safe and efficient by the medical community. It has been utilized by countless women nationwide during the over twenty years it has been available.

The drug was first approved by the FDA in 2000, and then in 2016, 2019, and 2021, the FDA implemented changes to expand accessibility to the drug by addressing dosing and in-person dispensing requirements. These modifications also extended the drug's use later in pregnancy. However, challengers, including doctors and anti-abortion groups, contend that the FDA did not adequately study the safety implications of the drug when initially approving and making it more accessible in subsequent years.

The legal battle began in the spring when US District Judge Matthew Kacsmaryk, an appointee of former President Donald Trump, issued a ruling that would have halted the FDA's 2000 approval of the drug.

The judge argued that the FDA had failed to take into account "the intense psychological trauma and post-traumatic stress women often experience from chemical abortion." Throughout his ruling, the judge used terms such as "chemical abortion," "abortionist," and "unborn human," which are preferred by abortion opponents.

Kacsmaryk also implied that the FDA's data was minimizing how frequently the drug was mistakenly given to those with an ectopic pregnancy. He echoed the challengers' claims that the FDA's approval process had been influenced by improper political pressure. The 5th US Circuit Court of Appeals, a conservative court, partially reversed its decision, stating that while it was too late for the challengers to challenge the initial 2000 approval of the drug, it would halt the changes made in 2016 and 2021 that made the drug more accessible, while upholding the 2019 approval of a generic version of the drug.

Erin Hawley, representing the conservative Alliance Defending Freedom, stated in court documents that the agency approved the drug with numerous restrictions for safety reasons. In 2016, the FDA removed many of these safeguards without providing a proper explanation or evidence showing that it was safe to do so.

Although the justices agreed to review a court decision limiting access to the drug, they rejected a separate appeal regarding the legality of the FDA's 2000 approval of the drug.

Steve Vladeck, CNN Supreme Court analyst and professor at the University of Texas School of Law, said that the denial of the cross-petition may appear technical, but it is a strong indication that the Court is solely focused on the challenges from the Biden administration and Danco laboratories. Specifically, the lower courts' conclusion that the plaintiffs could bring this case in the first place. As a result, it is now less likely that the court will address the merits of whether the FDA lawfully approved and expanded access to mifepristone. Instead, the case is more likely to be resolved on procedural grounds that will not directly impact access to mifepristone in the future.

In September, Solicitor General Elizabeth Prelogar made an appeal to the Supreme Court, stating in legal briefs that over half of American women who opt for abortion rely on mifepristone, and multiple studies have demonstrated that its proper use rarely results in serious adverse effects. Prelogar warned that allowing the lower court decision to stand would disrupt the regulatory framework for mifepristone, causing harm to women seeking legal abortions and the healthcare system that depends on the drug being available under the current guidelines.

She stated that the "unprecedented decision" would also "pose a significant threat to disrupting the pharmaceutical industry and hinder the FDA from fulfilling its statutory obligations based on its scientific judgment.

She argued that the court should intervene in the dispute as it impacts the availability of a drug with lawful uses in multiple states and raises concerns about one federal court's ability to restrict abortion access in states that protect it.

According to Ellsworth, the 5th Circuit's decision is creating instability in the pharmaceutical and biotechnology industries by casting doubt on the sufficiency of scientific studies accepted by the FDA to support conditions of use.

Critics of the drug dismissed the government's stance and contended that if the judges ruled in their favor and limited the drug, it would still be accessible.

Hawley stressed that the lower court ruling wouldnt necessarily take the drug off the market, but it would restore "common sense safeguards."