Mifepristone, used in the majority of abortions in the U.S., has been approved to be sold at retail pharmacies, but how long it will remain on the shelves is unknown. photo by Robin Marty
A recent federal decision increases the availability of abortion medication in the U.S., but already faces legal challenges, leaving the future of the drug uncertain.
After the overturning of Roe v. Wade, women’s reproductive rights are currently an uncertain topic across the country. However, a recent decision by the United States Food and Drug Administration (FDA) is attempting to increase access to abortion care. On January 3rd, 2023, the FDA updated its policy that retail pharmacies that meet certain criteria may now dispense and ship abortion medication. While this decision is significant for reproductive rights in the U.S., its impact across the country and continued existence is still in question.
Although it is only recently making headlines, the drug, called mifepristone, was approved in 2000. The FDA strictly regulated the medication to ensure its safe prescription and dispensing, but over the past two decades, these rules have been loosened. The most recent decision simply increases the amount of pharmacies where the medication can be dispensed and shipped. A pregnant person who has been prescribed mifepristone by a qualified healthcare provider and has been informed on the risks can pick it up from a retail pharmacy, like Walgreens or CVS. Patients can then use the drug to terminate pregnancy for up to 10 weeks after gestation.
Mifepristone is only one of two drugs needed to end a pregnancy, although it is more tightly regulated than its counterpart, misoprostol. First, a patient takes mifepristone, which blocks a hormone needed for pregnancy. Then, 24-48 hours later, they take misoprostol, which causes contractions to expel pregnancy tissue. Regarding the safety of the medication, the FDA assures that it was approved, “based on a thorough and comprehensive review of the scientific evidence presented and determined that it was safe and effective for its indicated use.” Of course, there can be serious complications, but these only occur in 0.4% of cases, and with over a 99% efficacy rate, it is clear why it is used in more than half of all abortions in the U.S.
Though the change is certainly momentous due to the current state of abortion rights, it was not decided because of recent reversals of abortion rights. In 2017, the American Civil Liberties Union (ACLU) challenged rules on mifepristone in the case Chelius v Becerra arguing that the restriction, “severely restricts access to abortion care with no medical basis, imposing particularly significant burdens on low-income patients, people of color, and people living in rural areas.” This case prompted the FDA to review their regulations and ultimately make the adjustment in January. This change was certainly a win for the ACLU, but due to evidence of its safety and the current state of abortion in the country, the union wants more of the regulations on mifepristone to be eliminated.
Due to different laws concerning abortion across the country, there are questions and even lawsuits that challenge the legality of mifepristone in certain states. In the 12 states with laws banning abortion after six weeks of pregnancy, it is unclear whether these laws can override the federal approval of the drug and ban it. Greer Donley, an expert on abortion law and bioethics at University Pittsburgh, explained to Stat News, “Right now, states are assuming that they have the power to do whatever they want on abortion. It’s not actually going to make any difference at all on how states act unless a court actually issues a ruling.” Already, lawsuits have been filed in West Virginia against the full ban on abortion and in North Carolina regarding extra restrictions on the medication. Both argue that banning mifepristone goes against the Constitution, which gives the FDA the authority to make regulations on a federal level, superseding state laws.
On the other side, a Texas lawsuit filed last year by the Alliance of Hippocratic Medicine threatens to ban the drug entirely by establishing the FDA approval of the drug back in 2000 to be illegal. “The FDA never studied the safety of the drugs under the labeled conditions of use,” claims the Alliance Defending Freedom, a Christian organization representing the Alliance of Hippocratic Medicine, despite significant FDA research before approval as well as continued evidence of its safety and effectiveness. A lawsuit questioning the legality of an FDA decision is unprecedented and could threaten the authority of the agency to approve drugs. In response, the FDA stressed that removing mifepristone from the market would harm women’s health and overburden surgical abortion clinics due to the popularity of medication abortion to end pregnancies. As these lawsuits are resolved, there may be more answers to the complicated question of women’s reproductive rights in this country.
