Federal Court FREEZES Biden-Era Mail Order Abortion Rule

Added: 2026-05-09

[00:00:00]The Fifth Circuit Court of Appeals has stayed frozen. The FDA's 2023 regulation under Biden that allowed abortion drug to be prescribed online and dispensed through the mail without an in-person physician visit. This was of course a response to the DOS decision that overturned Roie Wade. The FDA itself acknowledged that this rule was built on procedural deficits, quote unquote, and a lack of adequate consideration of safety. an admission that as the fifth circuit made plain all but mandates that they rule that this regulation was arbitrary and capricious and thus appropriate to be stopped under the APA, the administrative procedures act that has so frequently been wielded against our democratically elected Trump in this second term. All right, Louisiana verse federal drug administration in front of Southwick W. Bush appointee, Duncan Trump one appointee and Engelhart Trump one appointee. Starting with very important legal reality in dos v.

[00:01:11]Jackson Women's Health Organization, the Supreme Court returned the regulation of abortion to the states. That means the states get to make their own rules. So we talk a lot here about the supremacy clause where the federal government has regulated in a particular area. The federal law is supreme. It overrides any conflicting state law. But that's where the federal law is appropriately being wielded. In DOBS, the Supreme Court said, "No, abortion doesn't fall under federal government authority. It falls under the authority of the states." So therefore, any regulation passed by the federal government that conflicts with the states. It's the state law that's supreme. But in response to the DOS decision, the Biden administration, somebody certainly not President Joe Autoend dementia Biden directed federal agencies to expand access to medication abortion. The next year, the FDA formally altered its safety guidelines for the abortion drug. Under the new regulation, the drug could now be prescribed online, mail order, and without any need for an in-person visit to a doctor. So, this is how they were going to overcome state specific bans on surgical procedures for abortion. They were just going to say, "Hey, you can just get the pill. The pill will do it at home." In 2025, Louisiana challenged a new regulation in federal court under the Administrative Procedure Act, the APA. It argued the FDA's justification for remotely dispensing my pristone were based on flawed or non-existent data, especially safety data. It also documented how the new regulation had resulted in numerous illegal abortions in Louisiana and in Louisiana having to pay thousands in Medicare bills for women harmed by meristtoone. Louisiana sought a stay of the FDA's mail order abortion drug regulation while the litigation proceeded. So this is all in a preliminary stage, right? Nothing's been decided on the legal merits, but Louis Louisiana is asking, "Hey, while we're deciding it on the legal merits, we would like a a stay of that regulation."

[00:03:16]In essence, a preliminary injunction of the regulation. In response, the FDA conceded had to concede because there was no evidence to say otherwise, conceded it had failed to adequately study whether remotely prescribing meristone is safe. But the agency resisted pausing the regulation, arguing it was in the midst of a comprehensive review of Miffa Pristone protocols. And while they were determining whether or not it was safe, it should stay on the market. The FDA, however, could not say when that review might be complete and admitted it was still collecting data.

[00:03:53]This is 2025, so still the Biden administration. The unelected black robe tyrannical inferior federal district trial court agreed that Louisiana was likely to win its challenge to the mythopristone regulation and was suffering a reparable harm from the drug being made available mail order.

[00:04:11]Nonetheless, the trial court declined to stay the regulation based on its balancing of the equities and the public interest. Louisiana appealed to our court, the fifth circuit court of appeals, and sought a stay pending appeal under 5 USC 705. So, this is interesting because the just like for a preliminary injunction or a TTRO or a stay of an injunction or a TTRO, there there's the four factors that need to be demonstrated by the person seeking the action. The injunction, the stay of the injunction, and of course, we've covered those many times here. The first is likelihood to win on the merits. This is preliminary. This is before we get to the legal merits. Those arguments haven't been made yet. The final adjudication hasn't been decided. But while we're waiting to decide things on the merits, we'd like you to do what we're asking because we're likely to ultimately win on the merits. That's the most important fact factor in getting a stay, getting an injunction. The second of the four is you're suffering irreparable harm in the meantime if you don't get the stay or don't get the injunction.

[00:05:20]Likelihood to win on the merits, irreparable harm are are the by far the two strongest of the four factors to be considered. The other two factors are the ones emphasized here. Balance of the equities that just means balancing of the fairness and the interest of the public. Those those are those are given very little weight. in fact are hardly considered uh un unless you can't arrive at a decision on likelihood to win and irreparable harm. What happened here is it looks like the trial court made its decision on whether to stay or pause the FDA abortion drug mail order regulation based on the two least important factors and ignoring the two most important factors. That's one way to get to a politically politically driven legal conclusion. The fifth circuit court of appeals says, "We grant this stay pausing the FDA's mail order abortion drug regulation. We briefly review the FDA's actions with respect to the abortion drug uh we review prior challenges to those actions and we review the current lawsuit. When the FDA approved mephrristone in 2000, the REM allowed only doctors to prescribe it after three in-person visits and directed that patients report serious adverse events, toxic events.

[00:06:45]Since then, the guard rails have been progressively lowered. In 2016, the FDA announced that nurse practitioners could prescribe mephrristone after only one in-person doctor visit and that doctors needed to report only fatalities.

[00:07:02]In 2021, the FDI FDA stopped enforcement of the one visit requirement allowing meriststoneone to be dispensed through the mail or through a mail order pharmacy.

[00:07:14]That removal of the in-person dispensing requirement was formalized in 2023 after DOS reversed Roie Wade. In 2022, a group of physicians providing pregnancy related healthcare brought an APA challenge to the 2000 methristone approval, the 2016 lowering of the guard rails, and the 2021 decision to not require uh in-person prescribing.

[00:07:40]After the district trial court granted a preliminary injunction, our court affirmed in part, ruling that the plaintiffs were likely to win their challenge to the 2021 no doctor required decision. The Supreme Court reversed, however, on the grounds that the plaintiff physicians lacked standing.

[00:07:59]Remember, you have to have skin in the game, something to lose to be a party in federal court.

[00:08:05]In September 2025, the FDA began a comprehensive review of methristone, including the 2023 REM. When announcing the review, the FDA conceded the lack of adequate consideration underlying the prior REM approval, meaning the lowering of the guardrails. The review is not complete. As of April 2026, the agency reports it is still collecting data. In October 2025, the state of Louisiana and Rosalie Marazich, collectively the party, Louisiana, challenged the 2023 lowering of the guardrails, the mail order permission under the administrative procedures act.

[00:08:46]The district trial court allowed meriststone manufacturers Denko and Gen Biopro, collectively known as the parties Denko, to intervene as defendants. Louisiana moved to preliminarily stay pause the 2023 mail order permission under statute 5 USC75.

[00:09:07]The district trial court however declined to issue that stay that pause on the male order of the abortion drug despite finding that Louisiana had standing was likely to succeed on the merits and was suffering irreparable harm. And remember, standing is necessary for any party, but Louisiana clearly has standing. Its citizens are suffering toxic events and it's having to pay for their medical complications from this drug. Likelihood to succeed on the merits and suffering irreparable harm are again, of the four factors, the two most important by far.

[00:09:43]But although the court found that they were likely, Louisiana was likely to win on the two most important factors, it decided they were likely to lose on the least important factors, balance of the fairness and public interest, and therefore decided to deny a stay. This is clearly on its face a bad ruling by the district trial court. As to the equities, the fairness, the court reasoned that the FDA has a strong interest in continuing its scientific review of mephristone and that the intervenor companies or drug companies have a substantial financial interest in selling the drug. While acknowledging Louisiana's great interest in stopping the inflow of outofstate methopristone, the court thought the drug would likely continue to reach Louisiana regardless of his stay like other illegal drugs.

[00:10:32]It also emphasized that Louisiana retained many meaningful boots on the ground law enforcement mechanisms to mitigate its sovereign as a state and f financial harms while the FDA completes its ongoing review.

[00:10:47]As to the public interest, the trial court, the federal district trial court acknowledged that the public has no interest in continuing unlawful agency action and the FDA does not defend its decision-making on the merits in making the drug mail order. Nonetheless, the FDA desired a stay of the case to complete a wholesome review of the abortion drug. The court also noted multiple parallel lawsuits challenging the mail order permission and worried about the substantial risk of inconsistent judicial outcomes. But of course, that's what appeals are for.

[00:11:23]Finally, while again acknowledging the deficiencies in the permission to make the drug the abortion drug mail order, the court believed that it was illequipped to evaluate the validity of an in-person dispensing requirement, particularly where the FDA has thus far failed to even collect the data necessary to make that evaluation. The district trial court therefore declined Louisiana's request to pause the mail order of the abortion drug. Instead, the court granted the FDA's request to pause the entire case, the entire litigation brought by Louisiana so the FDA could complete its review. The district trial court warned though that the FDA has an obligation to act with all deliberate speed to review its past actions and complete a thorough analysis that addresses the deficiencies the FDA acknowledged about its own poor performance. Louisiana appealed that denial of the stay to this fifth circuit court of appeals uh on the permission to make the abortion drug mail order. And here we are. Under five USC 705, courts may issue all necessary and appropriate process to postpone the effective date of an ongoing agency action or to preserve status or rights pending conclusion of the review proceedings. A party seeking a stay under 705 must show the same four factors. It's strong strongly likely to succeed on the merits. Very important. Heavily weighted. It will be irreparably harmed without a stay. Very important. Heavily weighted. Its harm is not outweighed by harm to other parties. That's the balance of the equities.

[00:13:02]Very unimportant. Very lightly weighted.

[00:13:05]And for the public interest favors stay very unimportant. very lightly weighted.

[00:13:12]As this court says, the fifth circuit court of appeals, the first two factors are the most critical, likely to win on the merits and irreparable harm.

[00:13:22]Louisiana contends that the unelected black groy inferior federal district trial court misapplied those stay factors. This is complete mangling of how the uh these four stay factors are supposed to apply. Specifically, it argues the court abused its discretion in ruling that the last two factors, the least important, outweighed the state's successful showing on the first two factors, by far the more important. The FDA's response does not address the merits, whether its removal of methristone in-person dispensing requirement was arbitrary and capricious. Instead, it argues that Louisiana should have first asked the district trial court for a stay. It then argues, contrary to the district trial court's ruling, that Louisiana lacks standing. For its part, the drug company argues Louisiana lacks standing, failed to administratively exhaust its claims, and fails all four stay factors. Fifth Circuit Court of Appeals will address each of these in turn. We first, the fifth circuit court of appeals says we first address the two threshold arguments that Louisiana one should have first asked the district trial court for stay before coming to us and two on appeal and two failed to administratively exhaust his claims.

[00:14:42]Both arguments fail. The FDA contends that Louisiana was required to first ask the district trial court for a stay pending appeal. We disagree. While that is the ordinary practice, it's not required if moving first in the district trial court for a stay would be impracticable. Here it was. Not only had the district trial court already denied Louisiana's motion for a stay, but the court also stayed the entire case, the entire litigation pending completion of the FDA review. Given that the entire case had been paused, it would have been pointless to ask the district trial court to stay the mail order permission for the abortion drug. The drug company argues Louisiana failed to administratively exhaust its claims. So, what they're speaking to here is if you're um unhappy about something a governmental agency is doing, normally that governmental agency has ways for you to ask it to stop. And if they give you an answer you don't like to appeal that decision within the administrative agency. And normally the federal courts say hey before you can come to federal court with this stuff you have to exhaust all the steps you can take within the article 2 executive branch within the administrative agency. So the drug company argues Louisiana failed to administratively exhaust its claims before filing in federal court. As a general rule, claims not presented to the administrative agency here, the FDA, may not be made for the first time to a reviewing court unless resort to administrative remedies would be clearly useless. Our court previously rejected this argument in alliance one and alliance 2, which also involved this abortion drug two. Those decisions were reversed on standing.

[00:16:36]But their reason this was the cases where doctors filed complaining about the uh the mailorder drug. But their reasoning on exhaustion of administrative remedies was persuasive as they concluded these challenges were properly exhausted because the FDA's denials of citizen petitions discussed the non- enforcement decision that you don't need doctors prescribing it and showed that the FDA was committed to implementing these mail order changes.

[00:17:04]It was driven by politics after DOS reversed Roieway. The drug company gives us no reason to think that today the FDA would itself administratively pause the mail order access to this drug which it formalized in 2021.

[00:17:21]Accordingly, we reject the argument that Louisiana was required to administratively exhaust its claims before the FDA before bringing this suit. Then we turn to standing. Does the state of Louisiana have skin in the game here? Louisiana must show it has suffered an injury traceable to the defendant which the court's judgment would likely redress. So you you have actual damage, concrete, specific, particular, and a court could issue an order that would remedy that damage.

[00:17:51]That's what standing requires.

[00:17:54]And you have to have standing to be a party in federal court. On appeal, the FDA and the drug company dispute the district trial court's ruling that Louisiana has standing. Specifically, they contend that by removing Mephris's in-person dispensing requirement, the 2023 Rams, making it available by mail order, caused no injury either to Louisiana's state sovereignty, Louisiana has banned the drug, or its treasury. We disagree.

[00:18:24]First, sovereign injury. Louisiana has a sovereign interest in the power to create and enforce a local code. With certain exceptions, Louisiana law bans administering, prescribing, procuring, or selling a drug like meriststoneone to end the life of an unborn human being.

[00:18:45]And a vowed purpose of the mail order provision of the abortion drug was to expand access to Medicare abortion.

[00:18:52]Predictably, the regulation has had that effect in Louisiana, despite the fact that Louisiana's laws banned the practice.

[00:19:01]By ending the in-person dispensing requirement, the FDA open the door for the abortion drug to be remotely prescribed to Louisiana women. The record shows that the policy now facilitates nearly a thousand illegal abortions in Louisiana every month. This evidence also shows causation and redressability.

[00:19:24]As the trial court explained, out of state medical providers have responded to the mail order option by expanding zone access to prolife states like Louisiana in ways that are entirely predictable. That should surprise no one. After all, ensuring out of state medical providers could prescribe to women in states that restrict abortion was a goal of the regulation.

[00:19:51]Finally, a decision in Louisiana's favor would redress this injury because meristone could no longer be remotely prescribed to Louisianans.

[00:20:01]The FDA and the drug company counter that the mail order permission only makes it more difficult to police violations of Louisiana law. Not so. The policy does not merely increase crime or disorder or impose indirect compliant costs for state law enforcement. Rather, the mail order permission sanctions and facilitates conduct with the express purpose of undermining Louisiana's legal restrictions on abortion.

[00:20:31]The regulation creates an effective way for an out ofstate prescriber to place the drug in the hands of Louisianans in defiance of Louisiana law and sovereignty. In some the FDA's mail order permission for the abortion drug gives federal interference with the enforcement of Louisiana law, which gives Louisiana standing to challenge it. The district trial court raised various concerns about the equities and public interest. We do not find any of them tip the balance against Louisiana.

[00:21:05]First, the district trial court cautioned it was not a forum for resolving moral or policy disagreements, nor for adjudicating scientific and medical judgments committed by Congress to an agency with specialized knowledge.

[00:21:19]All quite true. This case, however, does not ask courts to resolve such matters.

[00:21:26]Despite dealing with the charge subject of abortion, at bottom, the case is an APA challenge to a regulation, a task courts routinely undertake. Second, the district trial court emphasized the importance of the FDA's being able to quote unquote complete a wholesome review and quote unquote proper science-driven evaluation of the abortion drugs protocols. Again, this is quite true.

[00:21:51]However, this challenge involves the existing 2023 mailorder permission, not the FDA's ongoing review. Granting a pause in the mail order of the abortion drug would do nothing to prevent the FDA from completing its review of the drug safety protocols.

[00:22:09]And consider what spurred that review.

[00:22:12]the AY's concession that its prior evaluation of the abortion drug, including the male order decision, was marred by procedural defects and a lack of adequate consideration.

[00:22:24]As Louisiana points out, it makes no sense to deny preliminary relief on the grounds that agency action is so unlawful that the agency openly conceds a review is necessary. That would mean an agency could forestall judicial review of admittedly unlawful regulations merely by promising to review them in the future. And here the FDA cannot even say when its review would be completed, perhaps over a year from now because it has not finished collecting data. Finally, the district trial court was concerned that because this case arises amid multiple parallel lawsuits across the country, there is a substantial risk of inconsistent judicial outcomes on a question of nationwide importance. That risk is inevitable in such litigation, however, because abortions treated differently in different federal districts. It does not absolve the courts from deciding the cases brought before them. If disagreement emerges, we have a Supreme Court. It's true, as the district trial court noted, that a stay of the mail order permission would, as a practical matter, have a nationwide effect. We do not agree, however, that this result is somehow intention with Trump v. Cassa, the Supreme Court decision where the Supreme Court ordered the lower courts to stop issuing all these universal injunctions. In CASSA, the Supreme Court plainly said it was addressing only equitable relief and not remedies under the APA. In some, we concluded the balance of equities and the public interest weigh in Louisiana's favor. So, all four factors weigh in Louisiana's favor. I forgot to pull it back up.

[00:24:07]Sorry about that. Accordingly, it's ordered that the motion to pause the mail order of the abortion drug is granted. All right. So, that's the fifth circuit court of appeals. And then we got then we got this hot stuff just today from the Supreme Court. Gen Bopro, another one of the drug companies selling this abortion drug v. Louisiana in the Supreme Court of the United States. Upon consideration of the application application of council for the drug company, it's ordered that the May 1st order of the United States Court of Appeals for the Fifth Circuit, which we just read, is hereby administratively paused until 5:00 p.m. on Monday, May 11th. That's a week from today. It's furthered ordered that a response to the application be filed on or before May se May 7th. So that's in 3 days. Samuel Alo. Now a couple things here. This doesn't give any indication of how Alto feels about any of this. Um each justice is um assigned to accept um motions, arguments um from various circuits. And it just happens that Alto covers the fifth circuit. Um, sometimes, you know, if it was a different circuit, it might have gone to Justice Jackson or Soayor or Roberts that they all have a part of the country that they they kind of they're the guy who gets the mail for those courts of appeal. This just happens to be Alto. Um, and then an administrative stay is different than uh a preliminary injunction or a TTRO. A good way to think about it is you get a preliminary injunction or you seek a preliminary injunction before you've gotten to the legal merits of a matter.

[00:25:47]So you're not deciding the legal merits.

[00:25:49]Uh you're just deciding, you know, is someone one party more likely to win and will they suffer irreparable harm if we don't pause what's going on? Even before a preliminary injunction, you can get a temporary restraining order. So if you get a preliminary injunction, it's in effect throughout the duration of the litigation, which could be months or or years in federal litigation.

[00:26:13]Before a prel and and so to get a preliminary injunction, there's there's normally um organized argument to the court. So each side is giving an opportunity to fully flesh out their arguments why they should get an injunction or why an injunction should not be granted. So, you're not arguing the legal merits of the case, but you are arguing the legal merits of the injunction pretty comprehensively.

[00:26:36]But before you get to arguing the merits comprehensively on the injunction, which happens before you get to the argument on the merits effectively, uh before you get to the injunction arguments, you can get a temporary restraining order. And a temporary restraining order is only a very superficial presentation of an an argument for why something should be paused. Often a TTRO is granted expart day. So only one party's in front of the court. The other party doesn't get to argue their side at all. And and for that reason, TRRO's are very well, they're temporary, right? Temporary restraining order. They're technically valid for only 2 weeks. They can be extended for another two weeks. But after the four weeks at the most, uh either they have to be done away with or they have to be converted into a preliminary injunction. And during that 2 to four weeks of the TTRO, that's where the more in-depth arguments for the preliminary injunction are being made. But the the the level the depth of argument you need for a TTRO can be very superficial, but it doesn't last very long. Even before a TTRO and the superficial arguments in a TTRO, you can ask for an administrative stay.

[00:27:47]Administrative stay, there's basically no argument being made at all. But what you're telling the judge, you're asking for the administrator to stay is, listen, uh, we really have an emergency here. We really have to maintain the status quo. We really have to freeze things where we are. I'm not prepared even to make the superficial argument I would need to make for a TTRO, but we need we need some kind of stay before we take the time even to argue a TTRO. And that's an administrative stay.

[00:28:16]So administrative stay is basically a stay granted on nothing on nothing just someone's claim that hey this is sufficiently important it should be paused before we even get to the TTRO stage and that's what Alto granted and of course these are very short right a TTRO is good for 2 weeks extends another two weeks maybe an injunction is valid for the durational litigation so months or years these administrative stays like here are commonly only good for a week we're going to give you one week pause.

[00:28:46]We're going to freeze everything the way it is, but we got to get this done in a week. And that's where we are with the US Supreme Court.