Key Highlights :
The U.S. Court of Appeals for the 5th Circuit issued a ruling on Wednesday regarding an order from a federal district court in Texas that challenged the Food and Drug Administration's (FDA) 23-year-old approval of the widely used abortion pill, mifepristone. The court agreed with the lower court that the FDA's moves since 2016 to relax the rules for mifepristone's use should be reversed, but declined to suspend the underlying approval of the medication.
The ruling will not affect the availability of the drug, since the Supreme Court of the lower court's order as the appeals process plays out. The order issued by the high court in April ensured the drug will remain accessible until the justices either agree to take up the case and rule, or turn down a request to do so. The panel also said the FDA's 2019 approval of a generic version of mifepristone, made by the company GenBioPro, should be left in place and "will also be available under the same conditions as Mifeprix."
The challenge to the FDA's approval of mifepristone was brought last November by a group of physicians and medical associations opposed to abortion rights. The group argued the agency failed to adequately consider the drug's safety and "chose politics over science" when it approved the pill in 2000. In addition to urging the court to withdraw the FDA's approval, the challengers sought to roll back the series of steps taken by the agency since 2016 to make mifepristone easier to obtain.
Under the tighter rules that the 5th Circuit said it would reinstate, the drug can be taken up to seven weeks into a pregnancy, rather than 10, and can only be prescribed by physicians. It must also be dispensed in person, instead of by mail. The FDA has argued that years of research show the rates of serious adverse events associated with mifepristone are low, and the drug has been taken by more than 5 million women seeking to end a pregnancy.
The panel of judges noted its decision is subject to the earlier ruling from the Supreme Court. The ongoing court fight has also injected more confusion into a legal landscape upended by the Supreme Court's decision last June to . Since then, roughly half of the states have imposed near-total bans on abortion or implemented stringent rules restricting access. Some have sought to make it more difficult for people to obtain mifepristone, including through the mail.
The Justice Department's appeal of the district court's decision was heard on May 17 by the three-judge panel. Elrod was appointed by former President George W. Bush, while Ho and Wilson were named to the 5th Circuit by former President Donald Trump. In addition to contesting claims about mifeprstone's safety, the Biden administration argued that the medical associations and physicians who brought the case did not have the legal standing to do so, as they failed to show they would suffer a concrete harm if the FDA's approval and actions increasing access remained intact.
The appellate court panel's decision, which itself is likely to be appealed, narrows an from U.S. District Judge Matthew Kacsmaryk that suspended the FDA's 2000 approval of mifepristone. The challenge involving access to mifepristone has been closely watched, as a decision curbing its availability would be far-reaching and impact states where abortion is legal.
Joined by former FDA officials and Democrats in Congress, lawyers for the Justice Department warned that if the district court's ruling is upheld, it would open the door to more challenges of FDA-approved drugs. But attorneys with the Alliance Defending Freedom, a conservative organization representing the medical groups and doctors, can be harmed if they're forced to complete surgical abortions due to incomplete medication abortions in violation of their conscience rights.
In the majority opinion written by Elrod, the 5th Circuit panel disagreed with the Biden administration on the question of whether the doctors and medical groups have legal standing to bring their case, a topic that was. Ultimately, the court upheld the 23-year-old approval of mifepristone, but said the FDA's actions since 2016 to make it easier to obtain went too far. This decision will not affect the availability of the drug, but will instead put the pre-2016 restrictions back in place. The court fight continues to inject confusion into a legal landscape upended by the Supreme Court's decision last June to . As the appeals process plays out, mifepristone will remain available to the public under the conditions for use that existed in 2016.