Danco

• 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.

• The administrative stay issued today stops Judge Kacsmaryk's order for the time necessary for the Supreme Court to rule on the requests for a full stay.
• The administrative stay means that the approved status of Mifeprex remains unchanged, including the 2023 revisions to the REMS that allow for dispensing from certified pharmacies and by mail.
• "It is temporary, but we look forward to the careful consideration we know the Court will give to these important issues.
• "  Because of the Court's administrative stay, Mifeprex remains approved for use through 70 days' gestation and with the dosing regimen approved in 2016.

• The lawsuit seeks to overturn FDA's two-plus-decade old approval of Mifeprex and its approval of a generic version of the drug mifepristone.
• The ruling states that the court is "staying" the 2000 approval of Mifeprex and all subsequent challenged actions related to that approval for the duration of the lawsuit.
• Danco is appealing this ruling and feels strongly that the rule of law should prevail in this case, which would result in a reversal of this ruling.
• Over 5 million women have used Mifeprex® in the United States since its approval for the termination of early pregnancy in 2000.

• The hearing laid bare both the unprecedented nature of the plaintiffs' legal theory and the speculative nature of their factual allegations.
• This too would upend the pharmaceutical industry and has no basis in (and in fact contradicts) the statute, FDA's regulations or case law.
• The plaintiffs ultimately were forced to admit that they could point to no precedent consistent with their view of the federal statutes at issue.
• Danco joined this lawsuit in order to ensure that the FDA approval of Mifeprex® remains in force and people continue to have access to this safe and effective product.