The Supreme Court has decided to stay the order of the District Court from Texas. Justice Alito wrote that he would deny the stay along with Justice Thomas and his reasoning for denying the stay is found in his brief opinion on the order granting a stay. The District Court order would have halted the FDA approval of the drug Mifepristone manufactured by Danco and would have essentially withdrawn it from the market; the appeals court placed the 2016 restrictions on the drug. At the Supreme Court, the FDA and Danco are the Plaintiffs.
In 2000, when mifepristone originally was approved for sale, the FDA required among other things that a doctor prescribe mifepristone; overtime, those requirements have relaxed and one of the elements of this current lawsuit is what dispensing restrictions are on mifepristone: whether it can be mailed, picked up at a pharmacy, or must be prescribed by a medical professional. State laws can go further than what the FDA requires, but the FDA sets federal requirements for dispensing any drug. Mifepristone is the first of two drugs that are commonly used to kill unborn babies using prescriptions instead of the surgery. A Stay means that there is a pause on the District Court’s order while the court fight continues.
Justice Alito notes explains the reason why he shares this opinion is because in other cases, the Court has been criticized for acting on applications for a stay without any explanation, but if that criticism and other criticism was valid in other cases, it’s true here. The Justice notes that oral arguments at the 5th circuit are on a fast track and will take place under a month later, so if their arguments on the merits are correct, the FDA and manufacturer will soon get the relief that they seek. One of the reasons why Justice Alito would deny this stay is because they have not shown they will suffer irreparable harm. In any federal case, there are 4 factors that any court must weigh in deciding an injunction: 1) plaintiff has a likelihood of success on the merits. 2) likelihood of irreparable harm to defendant. 3) balance of equities supports granting an injunction. 4) the public interest favors granting an injunction.
Although Plaintiffs want to point out the regulatory chaos due to the WA decision, it’s not clear that there is a conflict. Also, Justice Alito points out that the FDA hasn’t acted equitably because it uses injunctions to advance its policy goals and seeks to avoid further judicial review. Finally, the opinion alludes to the many news articles and views of democrats that the government should ignore an unfavorable order about pulling the drug from the market. The Justice closes with because this is just a stay, this is not his view on the merits of the issues presented.
In any event, this decision is only a temporary ruling about the drug while the litigation continues. If the Court doesn’t hear this case after the 5th circuit gives a final ruling, this stay will terminate. If the Court chooses to hear this case, the stay will remain in place until the judgment of the Supreme Court has been given
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