Explained | Why the legal status of abortion pill mifepristone hangs in the balance

Mifepristone has been safe and legal in the United States since the FDA approved the brand name Mifeprex over 20 years ago. In April 2019, the FDA had approved the first generic form of mifepristone following a review of the evidence that medication abortion is a safe, effective way to end an early pregnancy — with a safety record of over 99 percent. Mifepristone (also known as RU 486) is used to end a pregnancy within 10 weeks. It is usually used together with another medicine called misoprostol. Mifepristone must not be used in the case of an ectopic pregnancy. Mifepristone works by blocking the hormone, progesterone. Without progesterone, the lining of the uterus breaks down and the pregnancy cannot continue.  Misoprostol, the second medication, is taken either right away or up to 48 hours later, and causes the uterus to empty. It’s like having a heavy, crampy period and is very similar to an early miscarriage. Until 2019, mifepristone was only sold under the brand name Mifeprex, manufactured by Danco Laboratories. In 2019, the FDA approved GenBioPro, Inc’s application for generic mifepristone.

Medication abortion is the primary way people in the US use to terminate pregnancies. There are two medication abortion regimens that have a long safety and efficacy record: mifepristone with misoprostol, and misoprostol alone. Both involve taking oral medications to terminate a pregnancy.  In most cases, in a medication abortion, mifepristone is taken first to block the hormone progesterone. After 24 to 48 hours, a second pill, misoprostol, is taken to empty the uterus.

FDA guidelines stress that abortion-inducing pills are safe to use till 70 days, or 10 weeks, of pregnancy. Research has shown that it can be safe even later in pregnancy.

In 2011, the FDA added a Risk Evaluation and Mitigation Strategy (REMS),  permitting only medical providers who had obtained certification from the manufacturer to prescribe and directly dispense the drug. In December 2021, the FDA removed the in-person dispersing requirement for mifepristone and expanded the distribution to include certified pharmacies in addition to certified clinicians.

The use of medication abortion has grown significantly since its approval by the FDA in 2000. The FDA update of the REMS could expand the availability of medication abortion and broaden the use of telehealth dispensing. However, state abortion bans, specific bans on telehealth for medication abortion, and state-level requirements for in-person dispensation of mifepristone and for in-person counselling visits and ultrasounds that are not medically recommended will continue to restrict access in many US states.

In November last year, an anti-abortion group filed a case alleging that the drug was harmful and that claims been made by the medical associations have been debunked.

Last month, Judge Matthew J Kacsmaryk of the Northern District of Texas issued a preliminary ruling invalidating the FDA’s 23-year-old approval of mifepristone. A few days later, a three-judge panel of the US Court of Appeals for the Fifth Circuit in New Orleans struck a part of Judge Kacsmaryk’s ruling, allowing mifepristone to remain in the market, albeit with some restrictions.

The Texas judge’s initial ruling and the subsequent appeals court’s ruling were applicable across the nation, affecting even the states where medication abortion is legal.

There is no precedent for a US court overturning the approval of a drug that the FDA has deemed safe and effective. The case had come to the appeals court almost a year after the Supreme Court overturned the Roe v Wade ruling that had established abortion rights in the US. As many as 14 states have since banned abortion at all stages of pregnancy.

The defendants have argued that withdrawing access to mifepristone will affect dozens of other drugs similarly approved by the FDA. They have argued that the FDA has expedited the approval. Those opposing the ban have argued whether pregnancy should actually be considered an illness.

The fallout of the ruling, should it go in favour of the plaintiffs, would mean that mifepristone can become unavailable in the US. More legal battles will follow. Direct effects of the ruling may apply only in some states. There is a likelihood that medical abortions may still continue without mifepristone, using the other drug, misoprostol.

The ruling on the drug could have serious effects even for the states where abortion is legal. It can also cramp the FDA’s regulatory authority over other drugs. It can pave the way for all kinds of challenges to the agency’s approval of other medications and even enable the medical providers to contest the government policy.

According to some estimates, more than five million women have used mifepristone to terminate their pregnancies in the United States so far, and dozens of other countries have approved the drug for use.

After the Texas ruling, the Supreme Court ordered that the pill will remain widely available in the market for the time being. An appeal in the case is now before the Fifth Circuit appeals court, where on Wednesday, a different three-judge panel will hear oral arguments that are related to Judge Kacsmaryk’s preliminary ruling.

Any decision by the Fifth Circuit panel is likely to be appealed to the Supreme Court and so, the immediate availability of the drug is not likely to be affected. The final decision could entail a full access to mifepristone or restrictive access or even a withdrawal of the approval of the drug.

Those who have been opposing the drug have claimed that it was unsafe and the approval was flawed. The FDA has, however, contended that the drug is safe and effective.

A second case about the abortion pill challenging the renewed FDA restrictions on access to mifepristone is also pending in Washington State.

Besides these two, there are some more legal cases and appeals. They will all play a role in deciding the availability of mifepristone in the market.