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Home » The facts about the Supreme Court mifepristone decision

The facts about the Supreme Court mifepristone decision


This article about the recent Supreme Court decision on the abortion drug mifepristone was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about vaccination’s social and legal policies. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable diseases. She is also a member of the Vaccines Working Group on Ethics and Policy.

On April 21, 2023, the US Supreme Court stayed a lower court decision to issue a preliminary injunction revoking the FDA’s approval of the drug mifepristone, a decision the Fifth Circuit Court of Appeals left in place in part

This post explains why the Federal District Court and the Court of Appeals’ decision cause concern to observers. I have to say that I was not familiar with mifepristone before this set of cases. I’m happy to defer to our host, who points out that extensive data supports the drug’s safety, on the science.

Even without that background, both of the courts’ decisions raised many red flags for me. They, in essence, are second-guessing the FDA on matters within the agency’s expertise at the stage of the preliminary injunction, before the facts have been fully examined – and creating new avenues for, for example, standing to do so, deviating from previous jurisprudence.

There are four parts to the discussion by the lower courts:

  1. Do plaintiffs have the standing to bring this case? 
  2. What can they challenge, given the statute of limitations? 
  3. Did they exhaust administrative remedies? 
  4. Can they win on the merits? 

The new grounds suggested by the courts on A, B, and D are disturbing. 

This post will examine both the lower court and Supreme Court rulings on mifepristone. All of which gives an unbiased observer much to worry about.

Photo by Anna Sullivan on Unsplash

The procedural background of the Supreme Court decision on mifepristone

This background is summarized from both the district court and the Fifth Circuit’s decisions. 

In 2000, FDA provided accelerated approval to the drug mifepristone, a drug used as part of chemical abortion. The FDA limited the drug use for a period of up to 49 days of gestation, required three in-person office visits, required physician supervision, and required reporting of all adverse events from the drugs to the passive reporting system for drug adverse events – FAERS, which appears like VAERS, the Vaccine Adverse Events Reporting System, in that anyone can submit a report, with extensive reporting requirement for manufacturers, and the reports do not show causation.

The case examined here is brought by a number of doctors who allege that they treat women who had adverse events to mifepristone and medical associations who oppose the use of the drug. Apparently, two of the associations filed a citizen petition challenging the FDA’s approval of the drug in 2002. It took FDA until 2016 to deny the petition.

On the same day that it denied the petition, the FDA also changed the conditions for using mifepristone. It increased the maximum gestational age for using it from 49 days to 70 days, only required one in-office visit, allowed others besides doctors (like pharmacists) to prescribe and administer it, and removed the requirement to report non-fatal events to FAERS. 

Two associations filed a second petition in 2019 challenging the 2016 removal of restrictions. 

In April 2021, the FDA said it will use its enforcement discretion to allow sending mifepristone via mail during the pandemic.

On December 16, 2021, FDA denied most of the 2019 petition, including saying it will no longer require in-person dispensing (essentially allowing mailing of the drug to continue). FDA approved the official removal of the in-person dispensing requirement in January 2023.

The plaintiffs filed suit in November 2022. The district court granted them a preliminary injunction on April 7, 2023, against the FDA’s 2000, 2016, and 2021 decisions. On the same day, in a decision I’m not going to go into, a Washington State judge ordered the FDA to make no changes to the availability of the drug.

On April 12, 2023, the Fifth Circuit narrowed the preliminary injunction to the 2016 and 2021 decisions, so the 2000 approval was allowed to stand during the proceeding (the Fifth Circuit left its validity open, though), but the revised conditions from 2016 and the permission to send the drug by mail were put on hold until the litigation concluded.

On Friday, April 21, 2023, relatively late, the Supreme Court stayed the preliminary injunction on mifepristone – for those following, that’s a double negative – it means the Supreme Court said that the preliminary injunction (whose application has been delayed by the court hearing it until that point, so it has not yet come into force) will not stand, and the drug remains available until the case is decided on the merits. 

Justices Samuel Alito and Clarence Thomas dissented and would have allowed the preliminary injunction to stand, although only Justice Alito wrote a decision (I’ll summarize his decision at the end). We do not have an explanation for the majority’s choice to put the preliminary injunction on hold. 

black wooden gavel
Photo by Sora Shimazaki on Pexels.com

Standing for plaintiffs

Much of both decisions focused on standing. In the United States, plaintiffs need to have a specific interest in a claim; they cannot bring claims they do not have a stake in, and it’s the standing doctrine that is used to set that limit.

Both the district court and the Fifth Circuit allowed standing based on two grounds: 

  1. For the individual doctors having to treat women suffering adverse events from the drug. 
  2. The associations, for having to educate members about the drug.

Both arguments are highly problematic and in tension with existing standing doctrine.

First, for doctors, the Court of Appeals said that:

FDA thus cannot deny that serious complications from mifepristone are certainly impending. Those complications are right there on the “Patient Agreement Form” that FDA itself approved and that Danco requires every mifepristone user to sign. According to the applicants, more than 5,000,000 women have taken this drug since the 2000 Approval. FDA Stay App. 1. That means that, again according to the applicants’ own information, between 100,000 (2%) and 350,000 (7%) of mifepristone users had unsuccessful chemical abortions and had to “talk with [their] provider[s] about a surgical procedure to end [their] pregnanc[ies].” 2023 Mail-Order Decision at 10. And where did those hundreds of thousands of women go for their “surgical procedures”? Again, we need not speculate because the 2016 Major REMS Changes, the 2021 Petition Denial, and the 2023 Mail-Order Decision all allow non-doctors to prescribe mifepristone. The women who use this drug cannot possibly go back to their non-doctor-prescribers for surgical abortions, so again, as the “Patient Agreement Form” itself says, they must instead seek “emergency care” from a qualified physician. 

The plaintiff emergency room doctors have a concrete, particularized injury since they have provided—and with certainty will continue to provide—the “emergency care” that applicants specified in the “Patient Agreement Form.

This is problematic in several ways. First, it’s misleading on the facts. The court presents it as if hundreds of thousands of women would have to get emergency care for the drug side effects – but this conflates the risk of serious side effects and the 2-7% chance of the drug not working.

It’s not clear that if the drug does not work, a woman will get a surgical procedure – maybe – and it’s not clear if there will be any side effects if she does. There is nothing in the FDA’s materials to say that doctors will see 2-7% of drug users in the emergency room; that’s just not true on the facts, and the courts’ calculation of hundreds of thousands of women “experiencing mifepristone’s harmful effects” reaching doctors – and certainly the doctors in question – is without basis. The form also sends patients to “healthcare providers”, not necessarily doctors, for consultation.

Further, every drug has potential side effects, if only a severe allergic reaction. If a doctor can complain that having to treat one patient with side effects or having to focus on such a patient, gives them standing to sue against the drug, any doctor may have standing to sue against the approval of any drugs that may take time from other patients. Would this give doctors standing to sue tobacco companies if they need to work with a patient that got lung cancer after smoking? 

Doctors did not generally have standing just because they had to treat a patient they did not want to treat, and opening that door is problematic. 

The argument that another injury is the “adverse effects of mifepristone” causes “enormous stress and pressure’ physicians face in treating these women,” is even trickier. Does that give physicians standing to sue every time they’re faced with a stressful medical condition? Has the court thought this through? Can physicians sue drivers who caused a car accident? Unvaccinated individuals who infected others? Smokers who got cancer?

I can see all of these leading to situations stressful for physicians. The Fifth Circuit cited Sierra Club v. Morton for this argument, but that case simply acknowledged that environmental interests can lead to standing, and said nothing about stress on doctors from treating patients. It did mention the quality of life, but extending the argument in it to “any stress undermines quality of life enough to give standing” seems to essentially remove standing as a limit on what courts can hear. 

The associations’ claims of standing too are a bit strange. The court found they had a stake because “FDA’s actions have frustrated their organizational efforts to educate their members and the public on the effects of mifepristone.” The case they refer to is Havens Realty Corp. v. Coleman, 455 U.S. 363, 379 (1982). That case addressed action against a realty corporation for racial steering, and the complaint was that the corporation, by misleading people and steering them, undermined the association’s housing counseling and referral.

Comparing this intentional steering to the associations’ claims that FDA’s approval or conditions imposed work on them is strange. In this case, it’s not clear in what way FDA changing the approval conditions really made a difference to the association; if they want members to not take mifepristone, they already had to educate their members, as long as it’s approved. 

Timing

Challenging the case faces a statute of limitations of six years. In this case, the claim against the lawsuit was that the initial approval was in 2000 – more than six years ago – and the plaintiffs brought their case more than six years even after the denial of their first petition, which happened in 2016. 

The district court found that the initial approval was still on the table, because the FDA’s revising its conditions changed that initial approval. The Fifth Circuit overturned that part, but with language that made it clear that it thinks that the district court was right and that the changes to the initial requirements reopen the initial approval. This is a problem because initial conditions are often changed as new evidence emerges – and treating it as reopening the first approval it’s really tricky. As explained by lawyers analyzing this decision:

Modifications to REMS programs and drug labels more generally based on real-world product experience are not uncommon. However, if it is ultimately determined that changes to a REMS program can provide plaintiffs a refreshed opportunity to challenge the underlying product approval and not just the REMS modification, it will chill drug manufacturers from updating labels based on real-world evidence and may dissuade FDA from making any necessary adjustments to product labels including those subject to a REMS.

REMS means “risk evaluation and mitigation strategies,” and refers to the conditions accompanying approval to reduce risks. 

Exhaustion

Generally, people can only sue administrative agencies in courts once they’ve “exhausted” – fully went through – administrative channels to appeal. Both courts concluded that the plaintiffs, by going the petition route, exhausted remedies, and anyway, there are exceptions to exhaustion that apply – it would be futile to try and go back to FDA, and FDA should have met its own deadline to address petitions.

I have no problem with that part of the decision. I agree that the FDA claiming that plaintiffs should have tried to go back to them after it took FDA 14 years to answer the first petition is a bit jarring, and I’m okay with allowing faster access to the courts than that.

Arbitrary and capricious

This deserves a more thorough treatment, but I need to get this post out and turn to other things. The short version is that the standard used by courts to assess the substance of agency decisions is whether the decision was arbitrary and capricious, which looks both at the content of the decision and the explanation. The cases involve paying lip service to the need to defer to agency expertise, but courts can apply them in a more or less deferential manner. Here, both the district court and the appeals courts were not deferential at all.

The district court found that because the FDA did not make the conditions for giving the drug identical to the conditions in the clinical trials, it was arbitrary and capricious. But clinical trials generally have very strict criteria to allow more easily interpreted results (and limit risks to participants – an ethical requirement), and the inclusion and exclusion criteria do not generally make it to the final licensing of a product.

In other words, the judge was wrong in saying it was a problem not to use the conditions of the trial; that’s routine. The judge also attacked the 2000 approval because FDA did not include an “evaluation of the psychological effects of the drug or an evaluation of the long-term medical consequences of the drug.”

The judge also criticized not including girls under 18 in the trials or requiring an ultrasound before the administration. That is a very aggressive intervention in FDA’s discretion to conduct clinical trials, which is, well, unprecedented. This is exactly the kind of decision that is generally left to agency expertise, not to second-guessing by non-expert judges. Overturning a 23-year-old approval because of the judge second-guessing the clinical trial protocol is not something the arbitrary and capricious standard was designed for. 

Similarly, the Court of Appeals looked at two issues as, in its view, arbitrary and capricious – both related to post-2016 decisions of the FDA. The first, eliminating some conditions in 2016 was based on studies with those safeguards. This is problematic, because, to give one example, a move from three to one doctor visits may well be reasonable when studies show a low rate of problems after the drugs – and that’s true even if the studies were based on a three-visit regime. If three visits showed a low rate of problems, then maybe they are no longer necessary. 

Further, as the court mentioned, the FDA did look at eliminating some of the requirements. The court criticized the FDA for looking at requirements individually, but it’s not clear that that’s a problem – the FDA clearly did not think, for example, that eliminating three doctors’ visits required studying the gestational age. 

Second, the court concluded that eliminating the requirement that non-fatal adverse events must be reported to FDA means that later concluding the drug is safe is unfounded. But not requiring reporting does not mean problems will not be reported – and further, fatal events still needed to be reported. Pointing to the lack of safety concerns in the reporting system anyone can voluntarily is valid whether or not reports are required. Especially if – as here – there are other pieces of evidence, like studies. 

In both cases, the court intervened aggressively in FDA’s judgment, rejecting the agency’s safety assessment without a thorough review of the evidence. 

Comstock Act

Finally, both of the lower courts addressed the Comstock Act, which prohibits mailing drugs or substances that produce “abortion”. The problem with that is that it’s not clear that this is directly related to FDA approval – FDA is not going to mail anything. 

Final comment

Much of the Federal District Court decision had to do with the judge’s open hostility to abortion. The judge ruled that pregnancy is not a life-threatening disease, and in fact, not an illness at all, and therefore would not have approved the drug at all – and certainly not using fast track approval.

Judges are people, and it is impossible for them completely to leave their prejudice outside the court – but the lack of any effort here to leave the judge’s biases out of the decision was troubling. In one place, the judge said that “[n]othing in the Final Rule supports the interpretation that pregnancy is a serious or life-threatening illness.” Since women can and do die from pregnancy or childbirth complications, this is a problematic statement. 

The Supreme Court decision on mifepristone

The Supreme Court did not tell us why it stayed the preliminary injunction, or why it’s allowing mifepristone to be distributed while the case is going through the system. It may well mean that the Supreme Court is not convinced that the mifepristone case has merit, and will intervene, but we do not know.

The next steps are that the Fifth Circuit will hear the case. Whatever it decides, there will likely be an appeal to the Supreme Court, which may or may not hear the case about mifepristone again. We do not yet know where this will go. For more on that, see Professor Steve Vladeck’s post

We do know that Justice Alito would have left the preliminary injunction in place. He made three arguments. First, the court should not intervene because this is a request for an emergency stay in a case that has not been fully briefed, and the court was criticized for overturning lower court decisions in similar situations in the past. This is ironic since Justice Alito has been active in overturning lower court decisions in emergency procedures – on the court’s so-called shadow docket – previously. But in this decision, he criticized three of the court’s women justices who criticized such decisions before, Justices Barrett, Kagan, and Sotomayor. 

Second, Justice Alito argues that the FDA’s attempt to argue that the preliminary injunction would cause chaos is not valid because of the FDA’s “unclean hands” – trying to argue that the FDA is only relying on tension with another decision it likes better. But as Professor Vladeck says

…that’s not a remotely fair summary of the FDA’s position; even without Judge Rice’s ruling, Judge Kacsmaryk’s order, especially as modified by the Fifth Circuit, would have produced massive effects (including a fair amount of chaos) entirely on its own—because there would have been substantial uncertainty about what to do with stockpiled mifepristone (and whether doctors or pharmacists could continue to dispense it in states in which it is otherwise unlawful); because it would have taken the generic mifepristone entirely off the market; because Danco could not have continued to distribute any mifepristone in interstate commerce without going through a re-labeling and re-approval process; and so on. Perhaps Alito doesn’t agree that that’s “regulatory chaos,” but virtually none of those effects would stem from any conflict, real or otherwise, with the ruling from Spokane.

Third, Justice Alito suggests that there will be no harm because the FDA and the company will simply ignore the rulings and not act. There is no good basis for this, either, and saying there will be no harm because an agency will violate the law is a problematic argument.

In short, Justice Alito’s dissent appears problematic. 

Conclusion on the Supreme Court decision on mifepristone

The problem with this line of cases is that the courts, deviating from existing jurisprudence, acted in problematic ways in at least two areas. First, in giving standing to doctors based on those doctors seeing patients they do not want to see – or seeing potential adverse events from drugs – they seem to open the door, at least in cases they like, to plaintiffs that would not in the past have standing. 

Second, by being willing to completely second guess FDA’s discretion to design and run clinical trials and the way FDA assessed safety, they go beyond other courts in intervening in FDA’s discretion – and they do so for a drug approved 23 years ago. If they can do that, any drug approved in the past quarter century may be open to challenge, as long as plaintiffs can find a doctor that saw any side effects from it and find a judge that does not like that drug.

That can cut deeply into our careful system of drug approval and monitoring and is a concern. 

Dorit Rubinstein Reiss
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