THERE’S a battle underway over medication abortion, the most common method of terminating a pregnancy in the US. Widespread access to it is under threat given lawsuits attempting to overrule the way the Food and Drug Administration regulates the abortion pill mifepristone.
The Supreme Court is scheduled to hear arguments on Mar 26 in a case that will determine how available mifepristone will be. Until the justices decide the case, which should be by the end of June, they preserved the status quo and have kept the drug fully available. A conclusive judgment making it less accessible would further curtail access to legal abortion at a time when it’s already been significantly reduced in the US. It would also open the door to challenges to other FDA decisions.
1. What’s the case before the Supreme Court?
The Supreme Court will weigh the Biden administration’s challenge of an August appeals court ruling putting limits on access to mifepristone. The appeals court had rejected in part a decision by a federal judge in Texas to temporarily suspend the clearance of the drug, which was first approved by the FDA in 2000. However, the appeals court said decisions by the FDA starting in 2016 to expand access to mifepristone should be rolled back. Those decisions include allowing mail-order prescriptions, waiving a requirement of in-person doctor visits for a prescription, and extending the approved period for the drug’s use by three weeks to the 10-week gestation point. Those changes now hang in the balance at the Supreme Court.
2. What is mifepristone?
Mifepristone is an oral drug used to terminate a pregnancy. It works by blocking progesterone, a hormone that’s necessary for a pregnancy to continue. Doctors prescribe it with misoprostol, a drug used to treat stomach ulcers that can also induce contractions. When taken together, the two pills have been found to effectively end pregnancies with no further intervention about 98 per cent of the time. France was the first Western country to approve mifepristone to facilitate abortion, in 1988. Since then more than 90 countries have followed.
3. What are the side effects?
The most commonly reported side effects are cramping and prolonged heavy bleeding. Some people also experience nausea, fever and vomiting. In a study published in 2015 that analyzed data related to 55,000 abortions between 2009 and 2010, about 0.3 per cent of people who used mifepristone to end a pregnancy experienced a major complication, meaning they required hospitalization, surgery or a blood transfusion. Surgical abortions done in the first trimester of pregnancy, by comparison, resulted in major complications 0.16 per cent of the time. The risk of a severe complication from childbirth in the US was 1.4 per cent in 2014, according to the US Centers for Disease Control and Prevention; most commonly, the patient required a blood transfusion, hysterectomy, ventilation or a temporary tracheostomy.
4. How often is mifepristone used?
Over the years, medication abortion has become increasingly common in the US. It’s less invasive and more convenient than having a procedure at a clinic. The percentage of abortions carried out using pills in the US health care system rose to 63 per cent in 2023 from 53 per cent in 2020, according to data from the Guttmacher Institute, a reproductive rights research and advocacy group. Between those years, rule changes made it easier to get abortion pills prescribed via telemedicine and sent by mail, and many US states imposed abortion restrictions after the Supreme Court overturned its Roe v. Wade decision establishing a nationwide right to abortion.
5. What are the court challenges based on?
The anti-abortion groups suing the FDA argue that it fast-tracked the approval process for mifepristone and cleared the drug without sufficient scientific evidence. Two studies cited in the Texas court ruling to illustrate harms from mifepristone were later retracted by medical publisher Sage Perspectives. The anti-abortion groups also argue that the decision to extend the window for the drug’s use and to allow distribution by mail violate “crucial safeguards” intended to protect patients. In its preliminary ruling Aug 16, the appeals court said those FDA decisions were likely unlawful.
6. Was mifepristone’s approval fast-tracked?
No. The situation is a bit confusing because the drug was cleared under regulations known as Subpart H which allow the FDA to do two things: fast-track the approval of a drug by relying on preliminary data, and apply certain restrictions to ensure a drug’s safe use. In the case of mifepristone, the FDA only did the second thing. It relied on the usual standards for evidence of a drug’s safety and efficacy. And it added extra restrictions to mifepristone’s use, for instance requiring that a physician prescribing it be able to accurately assess how long someone has been pregnant. The FDA has denied that subsequent changes to its regulation of the medicine pose dangers to patients.
7. How available is mifepristone?
State laws on the legality of abortion, including medication abortion, vary widely. Fourteen states have near-total bans on abortion by any method and 15 states put limits on the pill’s distribution, including requiring people to take it at a doctor’s office. Operators of two of the largest drug chains in the US, CVS Health and Walgreens Boots Alliance, began dispensing mifepristone by prescription in March in states where it’s legal to do so. Previously, it was available at clinics, through the mail and at a small number of independent pharmacies. Increasingly, people living in states with restrictive laws are using telehealth services that operate outside the US to get pills prescribed and shipped from overseas.
8. Are there alternatives to mifepristone?
Misoprostol can be used on its own to terminate a pregnancy. The World Health Organization recommends its use up to 12 weeks in a pregnancy. While it’s also safe and effective, research has shown it has a slightly lower success rate and its side effects are more acute than those of misoprostol and mifepristone combined.
9. What are concerns about other challenges to the FDA?
If judges substitute their own scientific judgment for that of the FDA in the case of mifepristone, it will set a precedent for similar actions on any of the tens of thousands of drugs and medical devices the agency has approved. That could mean the removal from the market of life-saving vaccines or treatments based on a legal expert’s limited understanding of medical research. Also, such judgments could have a chilling effect on medical innovation. Bringing a new pharmaceutical product from inception to regulatory approval often requires significant spending and many years of effort. Drug companies warn that if judges can revoke the FDA’s clearance, they will have less incentive to make those investments. BLOOMBERG
