In a significant development surrounding the ongoing debate on abortion rights in the United States, the manufacturer of the widely used abortion pill, mifepristone, has requested that the Supreme Court review a lower court's decision limiting access to the drug. Danco Laboratories, the drugmaker, filed a petition with the Supreme Court, hoping to reverse an appellate court ruling that imposed restrictions on the pill's distribution and availability. These restrictions include preventing women from obtaining the drug through mail order and limiting its use to the first seven weeks of pregnancy.
The case arose from a lawsuit filed in Texas by a coalition of four doctors and a group opposed to abortion, following the Supreme Court's decision to overturn Roe v. Wade in June 2022. The plaintiffs requested a federal judge to overturn the Food and Drug Administration's (FDA) approval of mifepristone, which has been on the market for over two decades. In March, a federal judge issued a preliminary ruling suspending the FDA's approval of the drug. However, the Biden administration appealed the decision to the Supreme Court, which issued an order in April ensuring that mifepristone would remain available until the appeals process concludes.
The recent ruling by the Fifth Circuit Court of Appeals upheld the FDA's approval of mifepristone but introduced significant restrictions on its distribution. The ruling prohibited the drug from being sent through mail order or prescribed via telemedicine. This decision was seen as a victory by the Alliance Defending Freedom, the organization that filed the initial lawsuit against the FDA's approval of mifepristone. The group argued that the FDA failed to address important safety concerns when loosening restrictions on the drug. Conversely, the Biden administration and Danco Laboratories contended that the lower court's decision was unprecedented and contradicted the FDA's expert judgment.
Danco Laboratories highlighted the importance of the case, stating that it had wide-ranging implications for women, healthcare providers, and states that rely on the FDA's actions to ensure safe and effective reproductive healthcare. The company also emphasized the potential impact on the pharmaceutical industry as a whole, asserting that allowing judicial second-guessing of the FDA's scientific evaluations would have a destabilizing effect. They argued that the case sought to limit access to abortion rather than evaluate the safety of a drug that had been approved for over 20 years.
Mifepristone, also known by its brand name Mifeprex, is a pill used in a two-drug regimen to terminate pregnancies. It works by depriving an unborn baby of hormones needed for survival and inducing cramps and contractions to expel the fetus from the womb. According to Danco Laboratories, over five million women in the United States have used Mifeprex since its FDA approval in 2000. The drug has been found to be 97% effective in terminating early pregnancies, with a small percentage of women requiring surgical intervention for various reasons.
The Biden administration, through the Department of Justice (DOJ), filed a cert petition alongside Danco Laboratories, urging the Supreme Court to review the lower court's decision. The DOJ lawyers argued that mifepristone is the "best method" for terminating early pregnancies and emphasized that restrictions on access to the drug would harm women and healthcare providers across the country. They pointed to the FDA's previous determination that mifepristone is safe and effective and criticized the lower court's decisions for compelling the FDA to revert to a regulatory regime that the agency had deemed unnecessary and unjustified.
The Supreme Court's decision on whether to hear the case will have a significant impact on the future of abortion rights in the United States. If the Court agrees to hear the case, it could potentially rule on the availability of mifepristone and reignite the national debate on abortion. The outcome of this case could also have implications for the FDA's regulatory authority over other medications and the pharmaceutical industry as a whole. For now, mifepristone remains available in states where abortion is legal under FDA-approved conditions, but its future accessibility hangs in the balance as the case proceeds through the court system.