Ask the expert: What to know about pivotal case on abortion pill

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EAST LANSING, Mich. – The U.S. Supreme Court has now heard arguments on a key case involving access to abortions. Specifically, opponents are trying to hamper the use of a pill called mifepristone, a safe and effective pill accounting for about half of abortions in the United States. This comes as states are either further protecting abortion access or further restricting access, after Roe v. Wade was overturned in 2022. So, what could this case mean?

Mae Kuykendall is a professor emeritus of law from Michigan State University’s College of Law. Her research expertise ranges from constitutional law to race, gender and culture law, to First Amendment and corporate law. Kuykendall provides an overview of the case of Food and Drug Administration v. Alliance for Hippocratic Medicine and why the implications could be far-reaching.

How has the legal landscape for abortion rights changed since the overturning of Roe v. Wade?

It is fair to call the legal landscape chaotic. The Supreme Court did not place any limits on what a state legislature could enact to restrict the medical treatment of a person seeking an abortion, or even of a pregnant person in need of emergency intervention in a doomed pregnancy. Therefore, doctors hesitate to provide care in urgent cases because of uncertainty about their exposure to draconian penalties, including imprisonment and loss of their license to practice medicine. The inclination of some legislatures to deem a fertilized egg a person even places at risk exceptions to save a pregnant person’s life. Legislatures may recite as an exception to an abortion ban ‘the life of the pregnant person,’ but without providing guidelines, they effectively leave the fetus in a position of a competing life.

Doctors find themselves in a legal gray area that supports a ‘hands off’ approach in favor of the ‘life’ of the fetus. Indeed, even when a fetus is known not to be viable, ambiguity in the statutes lead doctors to prefer nonintervention. Physicians may well rely on the possible legal difference between nonaction that may lead to a pregnant person’s death or permanent harm over the affirmative action of performing an abortion, which a state prosecutor may deem as a killing — in violation of the abortion law. Recently, a panel of the Texas Medical Board, which has almost no gynecological expertise in its membership, held that it lacks the jurisdiction to issue a list of exceptions to the ban.

What is the background of the case for FDA v. Alliance for Hippocratic Medicine?

The case is one of the results of the ending of Roethough there is no explicit law governing abortion in it. Rather, it is an attempt by physician anti-abortion activists to use an administrative avenue to restrict access to a convenient, safe pill for causing the early ending of a pregnancy without surgery and with little discomfort. The background prompting the effort is the same element that brought about the overturning of Roe — former President Trump’s appointment of three anti-choice Supreme Court justices, as well as of many committed anti-choice judges throughout the lower federal courts. 

In effect, anti-abortion activists are using this case to make a collateral attack on women’s access to abortion in states where it is legal. Though unlikely, the tactic — if successful — would end or complicate access to a safe, low-cost, effective form of abortion care without necessitating direct consideration of the legality of abortion.

What is mifepristone and how does it work?

The pill is said to be used for about half of all abortions in the United States. It dilates the cervix and blocks the effects of the hormone progesterone, which is needed to sustain a pregnancy. Often, it is prescribed as the first medication to take along with a pill called , a drug also used to treat stomach ulcers, that is taken 24 to 48 hours after mifepristone to end a pregnancy. If mifepristone were to become unavailable, misoprostol can be used without mifepristone as a safe and effective abortion method, though taken alone the medication is associated with greater discomfort involving cramping and bleeding.

What is the history of rulings on the case?

In simple terms, the issue is, first, whether the FDA’s initial approval of mifepristone for use as an abortion method was done properly or should be rescinded by a federal court. For many reasons, it is believed the Supreme Court, which will hear the case this term, is unlikely to affirm the ruling of the district court. The FDA’s initial approval of mifepristone dates back to 2000. The challenge is past the statute of limitations. Indeed, the court is not really considering the issue of the drug’s 2000 approval, but rather the FDA’s later changes in approved protocol for the drug.

Based on experience with the safety and efficacy of the drug, over time, the FDA lowered the dosage, extended the gestational period in pregnancy during which it was available for use (from 49 days to 70 days), expanded the list of medical professionals eligible to administer it and, amid the COVID-19 pandemic, authorized the drug to be dispensed without an in-person consultation with a medical professional.

These changes were met with strong anger by the anti-abortion movement, which argued that the changes were designed to support the ‘abortion industry.’ Given the considerable convenience, low cost, and safety of mifepristone, the stakes are very high for anti-abortion forces determined to prevent as many abortions as possible, and for abortion-rights advocates and many fertile persons who believe it is a vital liberty for all citizens to control their own reproductive lives.

What is the issue of this case?

Scientific evidence presented to question the safety of the medication is weak. The basis for court jurisdiction is also weak in that the standing of the organization of physicians bringing the case is problematic. Despite a long history of safe use with few complications requiring medical attention, the physician group argues they may suffer distress if they ever must treat a person who has taken mifepristone. The claim is any subsequent treatment of a person who took mifepristone would involve the physician in providing treatment in an abortion. This argument for jurisdiction is weak because of court decisions that have set precedents limiting the validity of ‘possible’ injury to members of a particular group. 

If the FDA retains its authority to make science and evidence-based decisions for drugs and there is no national ban on abortion, it is likely the science of reproductive care using drugs will prevail at the FDA. A changeover in the White House, of course, could have implications for the ability of the FDA to follow the science of drug safety and efficacy, but that would require a much longer discourse on the independence of the administrative state and the efforts to undermine its place in the federal government.

If the Supreme Court finds access to this abortion medication can be restricted, what would it mean for women and reproductive care?

If the court decides that the 2016 and 2020 changes are invalid, the effect would be significant, but temporary, in part because the possible court-mandated revisions require changing the current protocol to comply with the older one. The various processes to bring mifepristone into compliance would take the pill out of circulation for a period. It also would restore the 2011 protocol, which mandated an in-person dispensing requirement.

It is not entirely clear how great the impact would be on availability because self-help is underway among abortion-rights activists who are accumulating stocks of mifepristone and mailing them or putting those in need in touch with European providers, in some instances mailing them into states where abortion is not legal. Further, misoprostol would still be available. With anti-abortion states seeking means to prevent their residents from accessing self-managed abortion care by obtaining pills by mail, and abortion-rights states seeking to protect those who obtain care for themselves or help another obtain abortion in their state, the future for women will be increasingly complex as states impose laws with opposite goals.

In addition, issues may arise in connection with the First Amendment guarantee of free speech if states move to restrict access to websites that provide a path to abortion and reproductive health care for persons in an abortion-banning state. In general, those with more money and personal means to access information and afford travel will likely maintain access, while poor women and minority groups with fewer resources may lose access to the adequate care. For young people who give birth because of lack of access to abortion, a recent study published in the Journal of the American Medical Association suggests that ‘teen pregnancy may be a readily identifiable marker for subsequent risk of premature mortality in early adulthood.’ It is well known that childbirth has a higher risk of mortality or other adverse results than early term abortion, such as by medication to which access may be made difficult. Some increase in short-term and long-term mortality for women and girls is likely.

What could occur in the meantime while we await the Supreme Court’s decision?

In anticipation of increased demand, providers are ordering more misoprostol. Any decision overturning the FDA’s approval and rules for use of a medication is considered worrisome and potentially radical in its effect on pharmaceutical companies in the United States. If companies cannot rely on the long and expensive scientific process undertaken to bring drugs to market, the certainty that underpins the business investments in drug development would be jeopardized. There is some reason to believe the court will deny standing to these anti-abortion plaintiffs. Nonetheless, the continuing concern among abortion-rights proponents about evolving legal tactics to hamstring access to abortion will create uncertainty about women’s ability to protect their reproductive health.

Countless scenarios involving the right of travel, free access to widely available medical information and unpredictable jurisdictional conflict will maintain an atmosphere of heightened alert and uncertainty. The end of Roe did not mean the end of legal and cultural conflict about women’s ability to control their fertility. Rather, it created a complex new venue in which claims of a state power to regulate women’s bodies will promote novel tactics aimed at restricting women’s personal autonomy over their reproductive lives as well as generate responses in legal and democratic venues by advocates of women’s reproductive freedom.

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