For over two decades, medication abortion has provided a safe and effective means for individuals in the United States to end pregnancies within the comfort of their homes. In states where abortion remains legal, medication abortion stands as a crucial and widely-used option, accounting for more than 60% of abortions in 2023.
Telehealth and mail delivery of abortion pills help ensure timely and safe access to care for women who live far from abortion providers or face prolonged wait times for in-person appointments.
Despite recent efforts by the Biden administration to improve access to medication abortion, anti-abortion politicians and extremist groups persist in their efforts to outlaw mifepristone, one of two pills used in medication abortion, as part of a broader campaign to eliminate abortion access nationwide.
On March 26, 2024, the Supreme Court heard arguments in a case that could take mifepristone off the shelves and make it illegal for health care professionals to prescribe it, even in states where abortion is legal. The case against the Food and Drug Administration (FDA) challenges the initial approval of mifepristone as well as recent removals of restrictions on how the drug can be obtained and used.
Mifepristone is a safe and effective medication that has been approved for use for abortion in almost 100 countries. It is used in a two-drug abortion regimen that was first approved in France and China in 1988. It was approved in the United States by the FDA for use for abortion in 2000.
Leading medical bodies such as the American College of Obstetricians and Gynecologists recognize mifepristone as part of the standard treatment regimen for miscarriage care, based on substantial evidence of its safety and efficacy. Numerous studies have underscored the safety of mifepristone, revealing it to be safer than commonly used medications like Tylenol and Viagra in terms of serious medical complications. The World Health Organization recognizes the importance of the two-drug regimen for decreasing unsafe abortion. It makes safe abortion care accessible where other methods of safe abortion are hard to access, for example, where someone would find it challenging to travel to an abortion clinic or would prefer to access the service from their home.
As one of the world’s largest providers of comprehensive safe abortion services, MSI Reproductive Choices has seen first-hand that mifepristone is safe and that it helps reduce unsafe abortion. Dr. Susana Oyamburu, MSI Mexico’s Medical Quality Supervisor, said: “Limitations to abortion access is what drives women to seek unsafe abortions and put their lives at risk.” This sentiment is echoed by services providers across the countries where MSI provides abortion care.
Despite the evidence of its safety, the FDA initially placed medically unnecessary restrictions on mifepristone in the U.S. including requirements for in-person prescription in a healthcare facility. These requirements make it difficult for some women, including women living in remote areas, women living in abusive situations, adolescents, and people living with disabilities to access the safe abortion care they want.
Citing data from research conducted by MSI in the United Kingdom, the FDA relaxed the in-office requirement during the Covid-19 pandemic, allowing mifepristone to be prescribed over the phone and either purchased at a pharmacy or delivered via the mail.
Medication abortion constitutes more than half of all abortions in the U.S. and in the majority of high-income countries. MSI research shows that it is not just effective, but often preferred. Since its approval, mifepristone has become integral to abortion access across the United States. Even prior to legal challenges to Roe v. Wade, medication abortion accounted for a significant portion of all abortions conducted in the country.
The case before the Supreme Court was filed by an organization called the Alliance for Hippocratic Medicine that argues, without evidence, that when the FDA eliminated the in-person prescribing requirement, it failed its obligations to protect the health and safety of women.
The case made its way to the Supreme Court after a federal district court in Texas issued a decision blocking the approval of mifepristone. It was the first time since the FDA was created by Congress in 1906, that a judge’s ruling challenged the FDA’s authority and expertise. In oral arguments, Supreme Court Justice Sonia Sotomayor highlighted the dramatic break from precedent in the district court’s ruling, calling the case “the only time any court has restricted access to an FDA-approved drug by second-guessing FDA’s expert judgment.”
The DOJ argued the lower court’s decision “did not conclude that mifepristone is unsafe” and that the negative impacts to clinical development and drug approval processes the decision could have on the pharmaceutical industry would result in a “seismic shift” that would destabilize the “rigorous, well—established and long-standing drug approval process.” Justice Ketanji Brown Jackson raised concerns about the Alliance for Hippocratic Medicine “seeking an order preventing anyone from having access to these drugs at all.”
Over the course of oral arguments, the justices expressed skepticism that removing mifepristone’s FDA approval was appropriate. A decision is expected in June, when experts anticipate the Supreme Court will uphold access to medication abortion.
As the United States navigates the absence of Roe v. Wade’s protections, attacks on reproductive choice continue to escalate. This newest case, which attacks the FDA’s authority over prescription drugs, doesn’t just threaten access to mifepristone, it has implications for other essential drugs used in reproductive healthcare.
The war on choice has only just begun. At least 14 U.S. states have enacted abortion bans, while others have placed more restrictive gestational limits on abortion care than existed under Roe. With each win, the opposition to choice grows stronger, bolder and more aggressive. MSI Reproductive Choices has the data and evidence that demonstrates the safety of medical abortion drugs. We have developed accessible guides and content to help people self-managing their abortions with abortion medication do so safely. We will continue to advocate for a woman’s right to choose and for greater access to all forms of reproductive healthcare, but we need your help. Please join us with a donation today.
