Supreme Court Petitioned by Justice Department to Review Landmark Abortion Pill Case

The Justice Department has submitted a request to the Supreme Court to hear a case concerning the availability of mifepristone, a commonly used abortion pill. This move raises the possibility of the justices making a ruling on the future of the drug.

The case revolves around access to mifepristone, which is utilized in more than half of all pregnancy terminations in the United States. It also has broader implications for the pharmaceutical industry and the regulatory authority of the Food and Drug Administration (FDA) over other medications.

The request was prompted by a ruling from a federal appeals court last month, which upheld the legality of the abortion pill but imposed significant restrictions on its distribution. These restrictions would prevent the pill from being delivered via mail or prescribed via telemedicine.

Currently, the pill remains accessible due to a previous decision in April by the Supreme Court, which stated that access to the drug would remain unchanged until the appeals process is complete.

The Supreme Court is likely to take action on the case in the coming months. They have the option to decline the case, thereby leaving the lower court’s decision in place, or to agree to hear it.

In its filing, the Justice Department referred to the appeals court’s ruling as an “unprecedented decision” that would have severe implications for the pharmaceutical industry and hinder the FDA from fulfilling its obligations. They also defended the safety and effectiveness of mifepristone based on studies showing rare serious adverse events.

The government lawyers emphasized the importance of access to mifepristone for patients who may prefer it over surgical abortion due to medical necessity, privacy concerns, or past trauma.

The implications for the pharmaceutical industry were highlighted in the brief, stating that the lower court’s decisions marked the first time a court restricted access to an FDA-approved drug based on disagreement with the FDA’s expert judgment.

Danco Laboratories, the manufacturer of mifepristone, also submitted a similar request, highlighting the significance of the case and the wide-ranging effects of any decision.

According to Danco, the case is crucial for women, teenage girls, health care providers, and states that rely on the FDA’s actions to ensure safe and effective reproductive health care. They argued that permitting judicial second-guessing of the FDA’s scientific evaluations would have a destabilizing effect on the pharmaceutical and biotechnology industry.

Danco further claimed that the case aimed to limit access to abortion rather than assess the safety of a drug that has been approved for over two decades. They contended that the lower court’s decision was influenced by plaintiffs who oppose all forms of abortion, despite not prescribing or using the drug themselves.

The case originated from a lawsuit filed in federal court in Amarillo, Texas, following the Supreme Court’s overturning of Roe v. Wade in June 2022. The plaintiffs, a coalition of doctors and an anti-abortion group, sought to overturn the FDA’s approval of mifepristone. The pill is part of a two-drug regimen for terminating pregnancies.

In March, Judge Matthew J. Kacsmaryk of the Northern District of Texas, known for his anti-abortion views, issued a preliminary ruling to suspend the FDA’s approval of the drug, effectively removing mifepristone from the market. The Biden administration appealed to the Supreme Court, which allowed widespread access to mifepristone until the appeals process was concluded.

Pam Belluck contributed reporting.