The Food and Drug Administration’s approval of mifepristone in 2000 was a milestone. Americans finally had access to a method of abortion that patients worldwide had used safely and effectively since it was first licensed in France and China in the late 1980’s. The FDA approved mifepristone based on extensive scientific evidence. Unfortunately, attacks on mifepristone are not new. Since even before its approval, anti-abortion politicians and activists have repeatedly attempted to prevent people from accessing this safe and effective method for abortion.
In November, a federal lawsuit was filed in the Northern District of Texas challenging the approval of mifepristone. It is critical to note that this lawsuit was intentionally brought in Amarillo to draw Judge Matthew Kacsmaryk, a Trump appointee, as the decider of the case. Earlier in his career, Judge Kacsmaryk fought against abortion, contraception, and LGBTQ rights. Since he joined the bench, Judge Kacsmaryk has issued anti-immigrant, anti-LGBTQ, and anti-contraception opinions. In December, he wrongly ruled that the longstanding Title X family planning program violated the constitutional rights of parents, eliminating access to confidential, medically accurate health care for thousands of young people.
The plaintiffs have asked the court to order the FDA to withdraw or suspend its approval of mifepristone for medication abortion as the case moves forward. If Judge Kacsmaryk agrees, access to mifepristone could be blocked – not just in Texas, not just in states that have restricted abortion, but across the United States, preventing health care providers from using a safe and effective medication for abortion and miscarriage care nationwide. The plaintiffs have even asked the judge to wrongfully apply the 150-year-old Comstock Act which could call into question the availability and use of other drugs and devices involved in reproductive health care.
The FDA had the authority to approve mifepristone for use in the United States in 2000 and they relied on voluminous medical evidence in doing so. Modifications made by the FDA since the initial approval have also been supported by scientific evidence. Study after study confirms that mifepristone is safe and effective. Although this lawsuit is baseless and not grounded in science or medicine, Judge Kacsmaryk’s alarming record causes deep concern for the outcome.
An adverse ruling could disrupt access to all aspects of reproductive health care, including medication abortion. Mifepristone, the medication that is at the center of this court case, is the first medication taken in the FDA approved medication abortion regiminen. Mifepristone works by blocking the hormone that allows the pregnancy to continue to grow. The second medicine, misoprostol, is a medication similar to hormones that already exist in our bodies. It causes cramping and bleeding, which makes the pregnancy pass and expel. As with a heavy period or a miscarriage, bleeding and cramping is a normal part of the process. This regimen is used by countless pregnant people across the country with safety and efficacy and its use has become increasingly more frequent since mifepristone was first approved. In fact, medication abortion makes up more than half of abortion care. We know that medication abortion and the medications we use are safe whether accessed in clinics, provided via telehealth, or self-sourced.
People will always need and will always have abortions. Those with means, resources and connections will continue to have access to this care, regardless of this ruling or any other regarding abortion. We saw this prior to the Roe ruling in 1973, in the years following the Roe ruling, and we are seeing it now in places where abortion is banned or severely restricted since the overturn of Roe. Despite the unequal and inadequate protections provided by Roe, elimination of this protection and a disruption to the availability of mifepristone will have devastating impacts on communities for generations to come.
The bottom line is that any restriction, barrier, or ban on abortion care results in people not getting the care they need in the time or way that they need it. When abortion is more challenging to access, we know that this means abortion care gets pushed later and later into pregnancy as folks try to navigate these barriers. Many are not able to do so. This means some people will be forced to remain pregnant. When people are denied wanted abortions, we know that their mental health, emotional health, and financial health suffer. Moreover, there are impacts on the health and well-being of individuals, their families and their communities.
If mifepristone is no longer accessible, in states where abortion is not banned, some people may still be able to access medication abortions using misoprostol only or by procedural abortion care. There are approved regimens of medication abortion using only misoprostol, and while it is equally safe as using in tandem with mifepristone, their dosage and timing to completion varies. And while procedural abortion is another safe and effective way to have an abortion, it does require making it to a clinic that provides abortion care; it cannot be accessed via telehealth or by self-management. Although options for care may exist in some places, other communities have options that are significantly limited or nonexistent. No one should have their care decided for them.
The goal is and has always been to eliminate access to abortion. Period. Disrupting abortion access, making it inaccessible, targeting, punishing people who have and provide abortions is just one tactic in the wheelhouse of anti-abortion extremists. As they continue to chip away at our human right to agency and bodily autonomy, providers, advocates, and organizers in community will work day in and day out to keep showing up for people as they navigate these complicated and scary times. Our community of physician advocates and activists across the country will continue to work to navigate the devastation, confusion and fear that this court case is attempting to sow. We will continue to show up for our communities, providing safe, compassionate care. We will not back down. We will fight.
See you next time,
Jenny Blasdell, JD
she/her/hers
Chief of Staff
Jamila Perritt, MD, MPH, FACOG
she/her/hers
President & CEO