DIGEST April 2023
The mifepristone diaries
Abortion pill mifepristone was the subject of multiple, conflicting court decisions in the US this week, leaving its status, and many of us, in a state of confusion.
First, on Friday, April 7, 2023, Judge Matthew Kacsmaryk of the US District Court in Northern Texas ordered the Food and Drug Administration (FDA) to suspend its approval of mifepristone, effective April 15. Mifepristone is the first pill in the two-drug regimen commonly used to induce abortion in the US (the second drug is misoprostol). This decision, if maintained, would have a catastrophic impact on access to abortion in the US.
Kacsmaryk is a notorious anti-abortion and anti-LGBTQ extremist, who was nominated to the federal bench by President Trump precisely because of these views. It's worth noting that the main plaintiff in the case, Alliance for Hippocratic Medicine, was incorporated by the Catholic Medical Association in Amarillo, Texas, where Kacsmaryk is based, just last summer—obviously with the intention of bringing this particular case before this particular judge.
Given his reputation, several state attorney generals had been bracing themselves for Kacsmaryk's decision and had petitioned the US District Court in Eastern Washington to maintain access to mifepristone. Their strategy worked. That same day, Judge Thomas Rice issued a preliminary injunction that directly contradicted the Kacsmaryk decision. In 17 states and the District of Columbia, Judge Rice maintained the status quo, i.e. keeping mifepristone on the market and allowing it to be prescribed by health providers other than doctors, picked up at certified pharmacies and/or mailed to patients using telemedicine.
Then, on Wednesday, April 12, the ultra-conservative Court of Appeals for the Fifth Circuit (which covers Texas) discarded Judge Kacsmaryk's suspension of mifepristone. The FDA's 2000 approval of mifepristone was so clearly time limited, even these judges had to concede it couldn't be reversed. But the Fifth Circuit couldn't refrain from intervening in some fashion. It decided that more recent FDA changes to expand access to mifepristone should be suspended until a full trial. These include approval of a generic, changes in the labeling of the drug (it had been re-labeled in 2016 for use until 10 weeks of pregnancy, up from seven weeks), as well as changes in who can prescribe it, and where and how it can be dispensed.
Judge Rice, meanwhile, issued a further order to object to Kacsmaryk's "nationwide injunction" against mifepristone, and to point out that "forum shopping" (choosing your judge to get a pre-determined result) was at play here.
The Biden Administration quickly expressed its concern about this attack on mifepristone. It also raised the alarm about the impact of Judge Kacsmaryk’s decision on drug approval more broadly: if any judge can revoke a drug’s approval they object to for personal or religious reasons, in flagrant contradiction of all scientific evidence, the development of pharmaceutical products in the US is in jeopardy. If they can impose conditions that the FDA's own statute doesn't require, how can drug developers plan their research? Are vaccines, contraceptives, infertility or hormonal treatments next? More than 400 pharmaceutical executives issued a letter making the same points: “If courts can overturn drug approvals without regard for science or evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone,” they write. All of this is now going to the US Supreme Court on an expedited basis.
So what does this mean for abortion access?
In the US, mifepristone was approved by the FDA, the federal agency authorized by Congress to approve pharmaceutical drugs, back in 2000—that was 23 years ago. Since it was first commercialized in the 1980s, mifepristone has been used by millions of pregnant persons worldwide, including 5.6 million in the US. Over the years, numerous scientific and clinical studies in the US and abroad have reviewed the safety of mifepristone: it has been found to be extremely safe and easy to use, with only 3-5% of patients requiring any kind of follow-up care, usually for the removal of remaining tissue in the uterus. It is considered safer than ibuprofen, penicillin or Viagra. Mife, as it is commonly called, is now used in at least 54% of all abortions in the US. Women like its ease of use and the ability to have their abortion in the privacy of their own homes.
One would think that would be that. But anti-abortion extremists were not satisfied with their Supreme Court “victory” against abortion rights in Dobbs last year. They will arguably never be appeased until every last abortion in the US is banned. Across the US, they have pushed for ever more restrictive abortion laws without any exceptions, and even for bans on travel between US states for abortion care. It comes as no surprise that abortion pills, which allow pregnant persons to overcome some of these restrictions, were next in their line of sight.
Judge Kacsmaryk delivered as expected. In his 67-page embarrassment of a decision, he suspended the FDA’s 2000 approval of mife by deciding that the FDA didn’t follow its own procedure back in 2000—what is termed, in administrative law, acting arbitrarily or capriciously. That would be a very dubious line of argumentation for invalidating the approval of any safe medication 23 years after the fact, but it is especially so when all evidence points to the FDA acting at the time with great (and I’d argue, excessive) caution in approving mife. Kacsmaryk also took it upon himself to rule that any subsequent modification to the conditions of use for mife required clinical studies that replicated these exact changes—something the FDA's own regulations don't require.
In his decision, Judge Kacsmaryk also spent a lot of time demonstrating that the plaintiffs have standing, i.e., that they have a right to sue. But it’s not clear what harm exactly mifepristone has caused these anti-abortion doctors. Kacsmaryk relied on fake studies by the Charlotte Lozier Institute, an arm of Susan B. Anthony Pro-Life America, to claim that complications after the use of mife are high, with patients overwhelming the medical offices and emergency rooms of these doctors. This is patently, outrageously false. Complications from abortion with pills are very low, and in fact vastly lower than complications from pregnancy and delivery. And besides that, persons who’ve had abortions are not likely to be flooding the offices of anti-abortion doctors.
The Court of Appeals (Fifth Circuit), aware that this question of standing is a real problem for the case, cited affidavits where doctors claim they've had to remove fetal tissue by performing dilation and curettage or vacuum aspiration in emergency rooms as a result of abortion pills. But if you think about it, isn't that what emergency room doctors are supposed to do: treat patients who come in with a medical problem? Don't doctors get remunerated for their work in the ER? How does that harm them? One of the affidavits gets to the crux of the matter: “The FDA’s expansion of chemical abortions also harms my conscience rights because it could force me to have to surgically finish an incomplete elective chemical abortion,” says one doctor. Yep. These doctors don't want to have to treat abortion patients, so let's eliminate all abortions. The Fifth Circuit concluded (incredibly but not surprisingly, given their conservative make-up) that this harm is sufficient for the case to proceed.
Kacsmaryk cited so much bogus science in his decision, it made my head spin. The Fifth Circuit didn't challenge this nonsense, and in fact repeated parts of it. For example, Kacsmaryk stated that women can’t self-administer abortion pills because ultrasound exams are required before their use. Nope. He claimed that women experience depression and suicidal thoughts after abortion—they don’t. Entering these lies into the court record was obviously the point, but it’s still shocking to read them.
Kacsmaryk also showcased his bias throughout: he repeatedly called health personnel who prescribe abortion pills “abortionists,” and described embryos and fetuses as “unborn humans,” “unborn children,” “babies” and “human beings.” He even invoked the 1873 Comstock Act, an anti-obscenity law that was at one time used to criminalize the mailing of contraceptives and abortifacients (as well as "lewd and filthy" art and literature), in order to bolster his decision to suspend mife. Puritanism is back.
Not coincidentally, the lawyers for the Alliance for Hippocratic Medicine are with evangelical Christian legal group Alliance Defending Freedom (ADF), well known for its virulent anti-LGBTQ and anti-reproductive rights litigation. ADF provided the template for the anti-abortion law at the heart of the Dobbs case. ADF is known to have connections to Supreme Court Justice Amy Coney Barrett. ADF’s general counsel is Erin Hawley, the wife of (insurrectionist and fast runner) Missouri Republican Senator Josh Hawley. This attack on abortion pills is clearly part of a systematic campaign by well-funded, well-connected far-right actors.
You might remember that in a previous Digest, I had criticized the FDA’s REMS (Risk Evaluation and Mitigation Strategy), a set of restrictions that makes access to mife more difficult than to almost all of the 20,000 other drugs on the US market. For example, when mife was first approved in 2000, pregnant persons had to go in person to a doctor's office or hospital to pick it up, and only doctors could prescribe it. Since 2016 and especially since COVID, those restrictions have been loosened by the FDA: mailing of mife is now allowed, pharmacies can now dispense it, and nurses can prescribe it. This has been critical to ensuring continued access to abortion to those who live in the growing number of US states where abortion is now banned. But the REMS has not been entirely removed. While pharmacies can now dispense, they still have to get a special certification. Two steps forward, one step back. The politics of abortion, I noted, are the only reason for a REMS to still be applied to mife, given its stellar safety record.
(As an aside, it is frustrating to note that, in his decision, Judge Kacsmaryk pointed extensively to the existence of the REMS to suggest that mife must be a “dangerous drug.” The Fifth Circuit did the same, even reproducing the Black Box warning on mife's packaging. Frankly, this whole situation only demonstrates that there is no appeasing the far-right, and that adopting an unnecessary REMS back in 2000 to try to placate them only comes back to hurt women later. Grrr!)
For his part, Judge Rice helpfully quoted the evidence of mife’s safety to explain his ruling: “Plaintiffs assert that (1) FDA acknowledges that serious adverse events are ‘exceedingly rare’, (2) mifepristone’s associated fatality rate is .00005%, with not a single death ‘casually attributed to mifepristone’, (3) ‘all the data shows the mifepristone is among the safest drugs in the world, and safer than the vast majority of drugs for which FDA has never attempted to impose a REMS’, and (4) ‘there is no reasoned scientific basis for subjecting it to additional burdens that are not applied to other, riskier medications.’ ”
Judge Rice then went on to suggest that, at trial, he would want to examine whether the FDA’s decision on a REMS for mife was so cautious as to be arbitrary: “It is not the Court’s role to review the scientific evidence and decide whether mifepristone’s benefits outweigh its risks without REMS… That is precisely FDA’s role. However, based on the present record, FDA did not assess whether mifepristone qualifies for REMS… based on the criteria set forth [under the law governing the FDA’s use of REMS]. Even under a deferential review, it appears the FDA failed to consider an important aspect of the problem.” That sounds promising.
What does all this mean in practice for access to mife? For the moment, mife is still on the market in the US, as is misoprostol. In the 17 states and DC covered by Judge Rice's order, all remains as before. In the other states (and unfortunately, they include "safe havens" New York, New Jersey, California and Massachusetts), it's not clear whether the older REMS is reinstated or not. Can a federally approved drug be subject to different conditions of use in different US states? This seems to be unchartered territory. Doctors can always prescribe off-label (i.e. past seven or 10 weeks of pregnancy), and many were already prescribing mife up to 12 weeks, as is recommended by the World Health Organization. But they can't ignore a REMS. The ability to mail mife, in particular, has been a safety valve for the clinics already overwhelmed with patients coming from prohibition states. Should providers now turn to misoprostol-only abortion (also safe and practically as effective), since misoprostol is not affected by these decisions?
The brand-name manufacturer, DANCO, filed arguments with the Supreme Court on April 14 explaining that even a temporary re-labeling would force them to re-package Mifeprex, which would require time and money, and could stop distribution for a while. Meanwhile, the generic manufacturer of mife, GenBioPro, faces the existential question of whether its sole product is now banned from the market in the states not covered by Judge Rice's decision. (Generic mife was approved by the FDA in 2019). And can the FDA overlook all of that using its discretion in enforcement, as some are arguing?
So, it’s a terrible mess. That was probably the point: continue to create a cloud of chaos and potential liability around abortion, and spook doctors, pregnant persons, pharmacists and manufacturers.
The Supreme Court is likely to rule on this preliminary stage very quickly, and even by the time this is posted. That is not a reassuring prospect, except for the fact that the Court is pro-business, and might want to assuage the pharmaceutical sector's worries. But one thing is certain: The Court's decision to overturn Roe did not calm the waters of the abortion debate, as Justice Kavanaugh spuriously suggested last summer. Now more than ever, it's clear that abortion is and will always be, a matter of concern for us all.
Meanwhile, remember to stock up your medicine cabinet with abortion pills, even if you or your loved ones don’t need them right now. You can do this with a modality called “advance provision”. Visit the Plan C and Aid Access websites. Several states, such as Washington, New York and California, are building their emergency stockpiles. You can’t say I didn’t tell you!
In solidarity, anger and determination,
FG