Abortion Pill Ruling: Read Annotated Excerpts From F.D.A. Case

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On Tuesday, July 13th, a federal judge in Maryland made a powerful decision regarding the distribution of the abortion pill, mifepristone. This medication is often used in combination with misoprostol to terminate a pregnancy, and has been the source of much controversy in recent years. Specifically, the ruling requires the Food and Drug Administration (FDA) to suspend a policy requiring women to obtain the medication in person from a healthcare provider before taking it, citing undue burden on women seeking the procedure.

The FDA first approved mifepristone, under the brand name Mifeprex, in 2000. However, it wasn’t until 2016 that the agency updated its guidelines to require patients to receive the medication from a certified healthcare provider, due to concerns around safety and potential complications. This decision came after years of pressure from anti-abortion groups who argued that the medication was dangerous and should not be accessible outside of a medical setting.

However, reproductive rights advocates and medical professionals have long maintained that the policy places an unnecessary burden on women seeking the procedure. These providers note that mifepristone is exceedingly safe and simple to administer, and that telemedicine and mail-order pharmacies could significantly increase access to the medication for those who need it.

The federal judge in Maryland, Theodore D. Chuang, agreed. In his ruling, he wrote that the FDA’s policy had placed “an undue burden on women’s right to an abortion” during the COVID-19 pandemic, when many healthcare providers have been closed or operating under limited hours. He specifically cited data showing that allowing medications like mifepristone to be distributed via telemedicine and mail-order pharmacies has not led to an increase in negative health outcomes, and therefore the FDA’s policy is medically unnecessary.

The decision has been hailed as a major victory for reproductive rights advocates and a crucial step towards expanding access to safe abortion care. However, it is likely that the FDA will appeal the ruling, and it may be subject to review by the Supreme Court.

In the meantime, it’s important to understand what this ruling means for women seeking abortion care, and how it could impact access to the medication moving forward.

First and foremost, it’s important to note that this ruling only applies to mifepristone, not misoprostol. That means that patients will still need to obtain the second medication in person in order to complete the abortion process. However, researchers note that mifepristone is the medication that most providers and patients report obstacles in accessing, as it is only available through certified healthcare providers and requires multiple visits, while misoprostol is much more widely available and can often be obtained without a prescription.

Furthermore, the ruling only applies to individuals seeking abortion medication within 10 weeks of their last menstrual period. This is the window in which mifepristone is most commonly used, and therefore the period during which the FDA’s policy was causing the most harm by delaying or preventing access to care.

Additionally, while this ruling is a powerful step towards expanding access to abortion care, it still falls short of allowing truly comprehensive access to medication abortion. Patients will still need to undergo an ultrasound in order to confirm the gestational age of their pregnancy, and will still need to have a follow-up visit with a healthcare provider to ensure that the medication was successful in ending the pregnancy. These requirements may present barriers to care for individuals who live in rural or underserved areas, or who cannot afford to take time off work to travel to a healthcare provider.

It’s also important to recognize that the fight for reproductive justice is far from over. While this ruling is a powerful victory for patients seeking access to safe and legal abortion care, it is only one step towards creating a world in which everyone has the right to control their own bodies and make their own choices about their reproductive health. We must continue to advocate for policies that expand access to care, fight back against attempts to restrict or criminalize abortion, and support those who are working tirelessly to ensure that reproductive justice is a reality for all.