Late last night, the United States Court of Appeals for the Fifth Circuit ruled that the abortion drug mifepristone can remain on the market but under strict conditions that effectively prohibit its use beyond seven weeks of pregnancy and bar its distribution by mail. In the closely watched court battle, the Fifth Circuit Court temporarily blocked the central aspect of a Texas-based federal judge's ruling that suspended the FDA's approval of the drug mifepristone in 2000. However, the Court permitted other aspects of the Texas ruling to take effect, and the DOJ announced this afternoon that it plans to ask the United States Supreme Court to block the Fifth Circuit's decision that limited the distribution and access to mifepristone.

The Defendants in the Texas case (i.e. FDA, HHS) sought a preliminary injunction pending appeal, arguing that the Plaintiffs lacked standing, their claims were untimely, their claims were administratively unexhausted, and the FDA's actions were not arbitrary, capricious or otherwise contrary to law.

The Fifth Circuit granted the Defendants motion for a preliminary injunction in part. "At this preliminary stage, and based on our necessarily abbreviated review, it appears that the statute of limitations bars plaintiffs' challenges to the Food and Drug Administration's approval of mifepristone in 2000 (up through 2016). However, the Fifth Circuit did not agree with the Defendants that the Plaintiffs were unlikely to succeed on the merits with respect to removal of the FDA's restrictions on mifepristone in 2016 through the present. See Fifth Circuit Ruling at page 7).

Of significance, we summarize some of the Fifth Circuit's legal reasoning as follows:

  • The plaintiff doctors, through their respective associations, had standing to challenge FDA's actions due to injury they suffered as a result of the FDA's failure to regulate the harmful effects of mifepristone;

.....we hold that on the record before us applicants know that hundreds of thousands of women will---with applicants' actions. And because applicants chose to cut out doctors from the prescription and administration of mifepristone, plaintiff doctors and their associations will necessarily be injured by the consequences. This is an exceedingly unusual regime. In fact, as far as the record before us reveals, FDA has not structured the distribution of any comparable drug in this way.

.....applicants' own documents-from the "Patient Agreement Form" to the "Black Box" warning that have accompanied mifepristone ever since the 2000 Approval up to and including today-prove that emergency room care is statistically certain..

See Fifth Circuit Ruling at page 19, 21 respectively.

  • Because the Fifth Circuit thought that the Plaintiffs could prevail on appeal with respect to modifications to the FDA's approval of mifepristone, the Fifth Circuit was unwilling to alter the District Court's ruling with respect to the FDA's modifications imposed in and after 2016;
  • The Fifth Circuit ruled that the Defendants failed to show at this stage that the Plaintiffs were unlikely to show that the FDA acted in an arbitrary and capricious manner when modifying earlier restrictions;

The fact that mifepristone might be safe when used with the 2000 Approval's REMS (a question studied by FDA) says nothing about whether FDA can eliminate those REMS (a question not studied by FDA).

See Fifth Circuit Ruling at page 35.

  • The Fifth Circuit refused to interpret whether the Comstock Act prohibits mailing of mifepristone given that there was uncertainty regarding the merits of the case with respect to this issue, and that because the uncertainty favors the Plaintiffs, the Defendants failed to bear the burden on the use of mail for dispensing mifepristone.
  • Thus, the FDA's 2000 Approval of mifepristone is stayed, and the REMS imposed in 2016 and thereafter are not stayed pending a hearing on the merits of the case.

It is likely no surprise to the Defendants that they would not receive full relief from the Fifth Circuit. It is also likely that the Defendants' plan to head to the U.S. Supreme Court was well underway prior to yesterday's Fifth Circuit ruling.

What comes next, is difficult to predict, but as new developments arise, we will continue to update our Dobbs Decision Resource Center. In the meantime, please contact one of the lawyers in Shipman's Health Law practice group if you have questions about this ever-changing legal landscape.

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