Danco Laboratories

• The decision is temporary, however, buying time as an appeals court weighs the challenge to mifepristone brought by a Texas judge in early April 2023.
• That ruling blocked the use of the drug in medication abortions and sought to remove it from the market altogether, questioning its safety.
• Days later, a U.S. appeals court reversed the suspension on mifepristone but placed tighter restrictions on it, including preventing it from being sent through the mail.

1. What led up to the Supreme Court’s ruling on mifepristone?

• The doctors brought the case in Texas, where a federal district judge ordered that, while the case was pending, mifepristone should be off the market.
• The FDA appealed to the 5th Circuit, asking it for an emergency “stay,” or a hold on, the district court’s order.
• The FDA, along with mifepristone’s manufacturer Danco Laboratories, immediately asked the Supreme Court to stay the 5th Circuit’s order.

2. What comes next in the courts?

• The Supreme Court’s decision means that mifepristone will remain available until there is a final decision in this case.
• Depending on the outcome of that case, either the plaintiffs or the defendants may ask the Supreme Court to hear the case.
• If the Supreme Court decides to hear the case, then the final decision on whether mifepristone should be taken off the market or have stricter requirements for use will come from the Supreme Court.

3. What does this mean for abortion access moving forward?

• The Supreme Court’s decision to preserve full access to mifepristone until the case concludes leaves the FDA’s current rules in place.
• Misoprostol, which is approved for use in the treatment of gastric ulcers, also causes uterine contractions and ends the pregnancy.
• These procedures would exacerbate harms to those electing or experiencing abortion, including risks to subsequent pregnancies.
• Even Supreme Court justices ambivalent about legal rights to abortion have expressed a desire for abortions to occur as early as possible.

4. What are the implications for other medications?

• The FDA did review multiple studies that showed lifting these individual restrictions was indeed safe for those taking mifepristone.
• Second-guessing the agency’s scientific determination in this way challenges the nuts and bolts of the FDA’s process and certainty in the drug manufacturing market.
• This is particularly true for medicine that may have higher risks but can be lifesaving for patients.
• Leaders from across the scientific, pharmacologic and business world have sounded the alarm at the implications of these decisions on approved drugs and those in development.