Bad Friday: Federal Judge Rules that 23-Year-Old FDA Approval of Abortion Drug Was Invalid

Posted in: Reproductive Law

At the close of business on Good Friday, federal judge Matthew Kacsmaryk released a ruling in Alliance for Hippocratic Medicine vs. U.S. Food and Drug Administration. The plaintiffs in this case argued that the FDA never should have approved mifepristone, one of the two drugs used in medication abortion. The judge agreed and issued a preliminary injunction to “delay” the approval of the drug, which has been on the market for 23 years. He then put his own order on hold for seven days to allow lawyers for the government the opportunity to give up their own observances of Easter, Passover, Ramadan, or spring break and scramble for an emergency appeal.

The ruling, not to put too fine a point on it, is bonkers. In this column, we will explain some of its worst offenses—misunderstanding of and interference with the FDA’s process for evaluating the safety and efficacy of drugs; reliance on junk science to cobble together an unconvincing theory of standing for the plaintiffs and arbitrariness of the FDA’s approval; and the manipulation of science, law, and language to hew closely to the anti-abortion playbook.

The Basics of the Ruling

The plaintiffs who brought this case are described in the ruling as “doctors and national medical associations that provide healthcare for pregnant and post-abortive women and girls.” (“Post-abortive”: this is the first of many times in the ruling that Judge Kacsmaryk substitutes his own anti-abortion terminology for accepted medical or legal terms.) They argued that the FDA’s approval of mifepristone was invalid.

The FDA approved this drug, which is also known as RU-486 or Mifeprex, in 2000 as part of a two-drug regimen to induce abortion using medication rather than a surgical procedure. Mifepristone blocks the hormones necessary for an embryo or fetus to develop, and a second drug, misopristol, induces cramping and bleeding that allows the contents of the uterus to be evacuated. Out of an abundance of caution, the FDA’s initial approval included various restrictions, such as that mifepristone could only be dispensed in person by a physician rather than through the mail or by a pharmacist. That restriction was relaxed in 2021 based on voluminous data that the drug could be used safely without these precautions and dispensed like other drugs through pharmacies.

Mifepristone is approved for use by the FDA through the 10th week of a pregnancy (and recommended for use under World Health Organization guidelines for an additional two weeks) and is used in more than half of the abortions in this country today.

Although the ruling is 67 pages long, Judge Kacsmaryk makes clear at the outset that his ruling is based on his own vehement opposition to abortion rather than on medical fact or legal analysis. For example, he describes the FDA approval of Mifepristone like this: “Mifepristone . . . is a synthetic steroid that blocks the hormone progesterone, halts nutrition, and ultimately starves the unborn human until death. Because mifepristone alone will not always complete the abortion, the FDA mandates a two-step drug regimen: mifepristone to kill the unborn human, followed by misopristol to induce cramping and contractions to expel the unborn human from the mother’s womb.” The inflammatory and inaccurate description says it all.

The rest of the ruling is a series of sleights of hand, each of which merits its own takedown. In short, the judge concludes that the plaintiffs have standing to bring this case either on their own behalf as doctors who do not prescribe the drug but are harmed by complications that can “overwhelm the medical system” or lead them to be complicit in “elective chemical abortion” or on behalf of patients who are harmed by medication abortion but unable to vindicate their own interests in litigation. He also concludes that federal courts have the power to review the FDA’s approval mifepristone, that the approval was invalid, and that there is sufficient evidence of irreparable harm that a preliminary injunction is warranted. Thus, he ends the ruling by granting a preliminary injunction that retroactively puts the FDA’s approval on hold pending a full trial on the merits.

Problem #1: Judge Kacsmaryk Upends the FDA’s Process and Authority

It is hard to overstate how aggressive and unprecedented the decision by Judge Kacsmaryk is. He writes that “[t]he Court does not second-guess FDA’s decision-making lightly” before doing just that, like saying “No offense, but…” before offending someone.

To appreciate how radical the opinion is, one has to understand both (1) the narrow, technical issue of how the FDA reviews drugs and (2) the much broader issue regarding how FDA review fits into our larger system of government, by which Congress endowed the FDA with immense responsibility to review new drugs.

First, the FDA approval process is incredibly complex, and those complexities are described in hundreds of pages of the U.S. Code, the Code of Federal Regulations, and numerous guidance documents issued by the FDA. The ultimate determination is whether a drug is safe and effective for its intended uses, which seems straightforward enough. But that determination depends on perhaps hundreds of procedural steps, judgment calls, and analyses of data that take years. Judge Kacsmaryk selectively critiques these procedural steps, second-guesses the judgment calls, and cherry-picks data to paint a picture of a rogue agency bending over backwards to approve mifepristone. But those of us who study and teach FDA law see a different picture: a judge bending over backwards to mischaracterize the procedures and data and judgment calls to reach a preordained result.

Just a few examples: Judge Kacsmaryk adopts the plaintiffs’ argument that the FDA erred in approving mifepristone under “Subpart H,” a regulation written by the FDA in 1992 to expedite approval of drugs treating “serious or life-threatening illnesses.” Judge Kacsmaryk agrees with the plaintiffs that pregnancy is not an “illness,” so the FDA’s use of Subpart H must have been invalid. (Pregnancy, according to the judge, is a “normal physiological state” and a “natural process essential to perpetuating human life.”) But the FDA has consistently applied expedited review programs to drugs targeting illnesses, diseases, and conditions. Judge Kacsmaryk ignores the agency’s longstanding practice and imposes his own cramped reading of Subpart H. Ordinarily, courts are exceedingly deferential to an agency’s interpretation of its own rules, and for good reason: the agency wrote them, after all. Moreover, Congress later endorsed the FDA’s broad reading in 1997 when it codified the FDA’s rules in the Food and Drug Administration Modernization Act. Both Congress and the FDA have been consistent in using the terms illness, disease, and condition interchangeably, but Judge Kacsmaryk contorts the evidence to suggest otherwise.

A second example from his opinion (there are many more): Judge Kacsmaryk criticizes how the FDA relaxed risk-mitigation plans for mifepristone over the years. He again cherry-picks data to paint a misleading picture that mifepristone is unsafe and that the FDA ignored safety data, when in fact mifepristone has been more carefully scrutinized than perhaps any other drug on the market over the last 20 years. Studies repeatedly show that it is safe and effective for its intended uses. So it would make sense for FDA to relax unnecessary safeguards over the years, not maintain them. Federal statutes give the FDA wide latitude to tailor its requirements to specific drugs depending on the risks and benefits they present. Again, those of us who study the FDA and its decisions see this as a right and normal part of drug regulation: after a drug is approved, we continue to gather data on the drug and tailor oversight to match these data. But Judge Kacsmaryk’s opinion suggests that he knows better than the FDA. Which is ironic because the FDA is, by nature, a relatively risk-averse regulator. In fact, a better case can be made that FDA’s safety restrictions on mifepristone have been unnecessarily restrictive rather than too lax. 

Finally, Judge Kacsmaryk critiques the fact that the FDA approved mifepristone without imposing all the monitoring mechanisms and safeguards used in the clinical trials studying the drug. This reveals a fundamental ignorance of clinical trials. The monitoring and safeguards are designed to get clean, usable data revealing whether the drug is safe and effective; they are not intended to be replicated in clinical practice. If that were the case, no drug on the U.S. market would meet Judge Kacsmaryk’s standards.

But enough about the narrow, technical things Judge Kacsmaryk gets wrong about the FDA approval process. The much bigger problem is a federal judge inserting himself into the larger scheme in which Congress authorizes an expert regulator like the FDA to make these incredibly complex, technical judgments about whether drugs will be safe and effective for patients. Yes, the statutes governing the process are complex. But those statutes are informed by the FDA (heck, many are written by the FDA) and give incredible responsibility to the agency to use its best judgment, so long as the product meets the statutory standards of safety and efficacy. There is a reason no court has ever overturned the approval of a drug contrary to the agency’s judgment. It is an extraordinary power grab by the judicial branch, showing disrespect to two coequal branches: Congress, which saw it fit to authorize an expert agency to review these decisions; and the Executive Branch, which uses a U.S. Food and Drug Administration to make these painstaking decisions.

Problem #2: The Opinion Relies on Junk Science and Ideology

At various points throughout the opinion, Judge Kacsmaryk makes claims about the dangers of mifepristone and the experiences of patients who take it. These claims are not window dressing—they are essential components of his legal analysis. But almost nothing he says about the drug, or about abortion in general, is true.

At the heart of his ruling is the claim that medication abortions are unsafe. Nothing could be further from the truth. There are more than 100 scientific studies showing that they are safe, even when used without any involvement of a healthcare provider such as with a self-managed abortion. They are safer than taking Tylenol and Viagra and, more importantly, far safer than childbirth. And while some patients who take the drug may seek emergency care because of the amount of bleeding or pain they experience, these situations are rarely serious. Although he suggests that emergency departments are “overwhelmed” by providing care to patients after medication abortions, there simply isn’t any evidence this is true. In fact, all available data suggest that complications of medication abortion are rare, usually minor, and seldom require follow-up care.

Safety is a relative concept. Kacsmaryk cites one person who allegedly died last year from a medication abortion during the gestational period for which mifepristone is approved for use but fails to mention the 1,200 or so who die every year from pregnancy-related causes. A person is fourteen times more likely to die of pregnancy-related causes than from abortion, whether surgical or medical. Abortion is one of the most studied medical procedures because of political opposition, and years of gathering statistics have served simply to show how very safe abortion is. In Texas, in the five years prior to the enactment of SB 8, which ended most abortions in the state, there was only a single death from abortion among 250,000 patients; the maternal mortality rate in the state would predict 40-45 deaths for a cohort of that size. Moreover, if a single death made a drug “unsafe,” even when causation is not firmly established, then very few drugs approved by the FDA would meet that standard.

Judge Kacsmaryk also relies on well-worn myths about the effect of abortion on mental health. For example, he claims that “[w]omen who have aborted a child—especially through chemical abortion drugs that necessitate the woman seeing her aborted child once it passes—often experience shame, regret, anxiety, depression, drug, abuse, and suicidal thoughts because of the abortion.” There is simply no support for this claim. Peer-reviewed, published studies find no evidence that abortion causes depression. (Examples from this body of research can be found here and here.) Indeed, the Turnaway Study, the largest longitudinal study of women’s experiences with abortion and unwanted pregnancy recently found that women who have abortions are not more likely than those denied to have depression, anxiety, or suicidal ideation, and that 95% of women report five years later that having an abortion was the right decision. At the same time, women who are denied an abortion are more likely to suffer anxiety and loss of self-esteem in the short term.

But rather than relying upon well designed studies such as the Turnaway Study, which indicate that being refused a wanted abortion causes harm to both the person who sought an abortion and their children (including a significant increase in the risk of poverty), Kacsmaryk’s opinion contains scientifically false and pseudoscientific “studies” citing the harms of abortion. One of the sources he cites several times is a “study,” which is based solely on anonymous posts on an anti-abortion website called “Abortion Changes You.”

Problem #3: Judge Kacsmaryk is Blatantly Doing the Bidding of the Anti-Abortion Movement, and the Reverberations are Alarming

Although antiabortion activists argued in Dobbs that they wanted to return the issue of abortion to the states, the ultimate goal of the movement is a national ban on abortion and the embrace of constitutional protection for fetal personhood. This lawsuit, and Judge Kacsmaryk’s ruling, have implications for abortion across the country, with the most significant impact in states that themselves have decided to protect the right to abortion.

Lack of Access to Mifepristone in All States

After the Supreme Court issued its ruling in Dobbs v. Jackson Women’s Health Organization (2022), states became free to enact previability abortion bans for the first time in 49 years. (The ruling and its implications are discussed here.) Several states did just that (such as Texas, whose ban is discussed here), but others did the opposite—they passed new laws to protect access to abortion—or took no action to restrict abortion. Yet this lawsuit threatens abortion access across the country.

The majority in Dobbs wrote that states will be free to decide whether abortion should be legal in their state; Justice Kavanaugh emphasized in his concurring opinion that “nine unelected Members of this Court do not possess the constitutional authority to override the democratic process and to decree either a pro-life or pro-choice abortion policy for all 330 million people in the United States.” Yet this ruling would do exactly that because of the unsupported analysis of a single federal judge who is so devoted to the antiabortion cause that he dressed his own toddler in a shirt that says “I survived Roe v. Wade.”

The immediate aftermath, if the opinion takes effect, could be the lack of access to mifepristone in every state. The effect of the ruling is complicated in part by a ruling the same day from a federal court in Washington that orders the FDA to maintain the status quo on mifepristone approval in the seventeen states that filed that lawsuit. It’s also unclear whether the FDA can be ordered to withdraw approval for the drug, which has never happened before, and which some experts argue isn’t possible. However, one important lesson from the last few years of litigation over abortion access is that fear of legal consequences can have a powerful chilling effect even if those consequences are illegitimate or unlikely to occur.

Even prior to this decision, Walgreens made national headlines for announcing that it did not plan to dispense mifepristone in their retail pharmacies in states with a Republican governor because of threats they received from 21 state attorneys general, even if the FDA certified them to do so.  For example, Walgreens notified the attorney general of Kansas that it did not intend to dispense mifepristone within the state, even though abortion remains legal there because it is protected under the state constitution. Even if the FDA uses its discretion and decides not to act on this opinion, this may not give enough reassurance for manufacturers and pharmacies to carry the drug, regardless of whether the pharmacy is in a state that retains strong abortion access. If there is a question about the status of FDA approval of mifepristone, manufacturers of the drug may be wary of selling the drug in the United States. Therefore, people in states with protective abortion laws might nonetheless lose access to the drug. Although it is possible to induce abortion using only misopristol, whose approval has not been challenged in part because it has other approved uses, this method is not as effective, takes longer to complete, and causes more side effects and discomfort for patients. Thus, pregnant people seeking an early-stage abortion will suffer more because of this ruling, whether they live in a state that has criminalized abortion and where the work of the federal courts is divvied up in ways that allow antiabortion plaintiffs to pick their judge, or whether they live somewhere that cares deeply about the well-being of women and children.

The Next Step: Fetal Personhood

The decision uses language that is clearly trying to give personhood status to a fetus. As mentioned above, Judge Kacsmaryk substitutes inflammatory language even when purporting to describe medical facts or FDA actions. For example, he uses the word “unborn human” and “unborn child” throughout the opinion to describe a fetus. He indicates that this term is more scientific than “fetus” because it includes zygotes, blastocysts, or embryos. (“Embryo” would be more accurate than fetus since the embryonic stage lasts for eight weeks after fertilization, which is ten weeks from the first day of the last menstrual period and co-extensive with the period for which mifepristone is approved. But why let science derail an op-ed masquerading as a judicial opinion?)

This opinion is clearly trying to create a record that ascribes legal personhood to the fetus. If fetuses (and zygotes, blastocysts, and embryos) are given personhood status under the law, destroying them would be akin to murder. If the Supreme Court eventually decides that fetuses are merely pre-born humans who should have equal or greater rights as compared to the pregnant person hosting them, there will be devastating circumstances. Fetal personhood would lead to a nationwide abortion ban. Such a ban would mean forced pregnancies—even more than there are now. This can be akin to a death sentence for some groups, such as Black women who nationwide are three to four times more likely to die in childbirth. Additionally, it could mean an end to research involving embryonic stem cells, as well as common practices used with in vitro fertilization, such as the discarding of embryos.

Although the Dobbs opinion indicates that it is somehow giving power back to the states, the opinions of people in those states about abortion or fetal personhood won’t matter if fetuses are granted personhood rights. We know that legislative efforts to grant fetal personhood have been unpopular even in the reddest of states. For example, in 2011, Mississippi attempted to pass a state constitutional amendment that would have defined human life as beginning at the moment of fertilization. Fifty-eight percent of voters rejected that amendment. Similarly, Louisiana attempted to pass a bill last May that would have criminalized abortion. In that bill, they defined an unborn child as starting at fertilization. (Some of the implications of fetal personhood are laid out here.) Many doctors rallied against the law noting that it would directly impact in vitro fertilization and those suffering from infertility. Yet, just as the anti-abortion movement is unmoved by the fact that more than 70% of people in this country believe abortion should be legal, it is unfazed by opposition to fetal personhood. Judge Kacsmaryk is using the power of the judicial bench to give them leverage. The whole opinion reads like a summary of anti-abortion talking points rather than a legal opinion.

Criminalization and Targeting of Pregnant People

This decision will undoubtedly lead to several states’ passing laws criminalizing the use, sale, and dispensing of mifepristone. We can expect pharmacists and pharmacies who dispense this medication to be targeted. Historically, we have seen states being reluctant to criminalize the pregnant person who illegally seeks an abortion, medication or otherwise. However, that appears to be changing, especially with the focus on fetal personhood. Kacsmaryk seems to place more importance on the unborn person than the actual, living, pregnant person (an emphasis also seen in the Dobbs majority opinion). Anyone endangering the unborn person using a drug that a judge has deemed non-FDA approved may be punished by states. States have attempted to punish pregnant people for harming their fetuses by using illegal drugs for decades. (The nature and scope of this problem is documented here.) Often those who are targeted in these criminalization efforts are poor women of color. Unfortunately, if the use of mifepristone is criminalized (and even abortion in general), we will see this disproportionately impact women of color, especially Black women, since they are more likely to seek abortions than white women.

No Drug is Safe

Finally, if one judge in Texas is allowed to invalidate FDA approval of a drug, it will be disastrous for public health. During the public hearing on this case, the plaintiff’s attorney admitted that there was no precedent for this action. Indeed, federal statutes and regulations have well-established procedures for the FDA to remove drugs from the market, and courts usually give these procedures priority before intervening. If this decision stands, we can certainly expect a barrage of similar lawsuits related to many drugs. Some may claim that certain medicines should not be available for a wide variety of reasons including antivax stances, religious beliefs against certain categories of medicines (such as contraception), or objections because of the nature of the research that led to the drug’s development (e.g., stem cell use). Drugs like PrEP for HIV and hormones used in gender transitions would undoubtedly be targeted. Pharmaceutical manufacturers should be concerned about what drug may be targeted next—and it appears they are because 250 executives of pharmaceutical and biotech companies just issued a public letter condemning the ruling. “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,” the letter warns, “any medicine is at risk for the same outcome as mifepristone.” Public health will suffer if this decision stands.

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