Abortion providers seek to order the FDA to remove existing restrictions, or to prevent the FDA from altering the availability of mifepristone.
On May 8, abortion providers in Virginia, Montana and Kansas filed a federal lawsuit against the Food and Drug Administration (FDA) seeking an order to maintain and expand access to mifepristone, one of two drugs commonly used for early abortion and miscarriage.
The lawsuit, filed by the Center for Reproductive Rights (CRR), comes in response to legal uncertainty caused by a Texas court ruling voiding FDA approval of mifepristone and a dueling Washington court order requiring the FDA to maintain access to the medication. Then the Fifth Circuit severely restricted access to mifepristone in an appeal of the Texas order. On April 14, the Supreme Court halted enforcement of these orders while the Fifth Circuit considers the merits of an appeal of the Texas decision. Medication abortion accounts for more than half of all facility-based abortion care in the United States.
“It is critical that abortion providers and patients obtain certainty in light of the chaos that is currently surrounding mifepristone,” said Nancy Northup, president and CEO of CRR. “We are suing on behalf of abortion providers in states where abortion access remains, but healthcare practitioners need protection for providing medication abortion.”
The FDA approved mifepristone in 2000, but placed the medication under unusual and burdensome restrictions.
The FDA subsequently repealed some of these restrictions, including a requirement forcing patients to obtain mifepristone in person at a clinic and a rule allowing only doctors to dispense the medication. But the FDA continues to impose significant restrictions on the medication, including requiring clinicians to register with the drug manufacturer before dispensing the medication and requiring patients to sign a statement that they are using the medication to end a pregnancy, even if the patient is using the medication for miscarriage. These requirements compromise the privacy and safety of abortion providers and patients, and discourage healthcare providers from offering medication abortion.
If previous restrictions are reinstated, they will prevent abortion providers from mailing mifepristone, barring telemedicine abortion. They will also severely limit which providers can independently prescribe the drug.
Since FDA approval in 2000, mifepristone has been used safely by over 5 million patients across the country. Leading medical and public health groups including the American Medical Association and the American College of Obstetricians and Gynecologists have spoken in opposition to the FDA restrictions on mifepristone.
Decades of robust scientific research show that mifepristone is one of the safest medications available—safer than Tylenol and Advil, the lawsuit argued. “By making mifepristone seem uniquely dangerous, FDA’s continuing restriction of mifepristone stigmatizes medication abortion and contributes to the chaos anti-abortion activists now sow. Plaintiffs are continuously facing the weaponization of [FDA restrictions] by anti-abortion activists around the country.”
The plaintiffs—independent abortion providers with limited resources in hostile states—explained how these restrictions and the legal uncertainly created by the Texas lawsuit endangers their practices and patients.
“Abortion providers like myself have faced relentless attacks for providing care to our communities, and are now facing the prospect of being sent back in time yet again,” said Helen Weems, APRN and owner of All Families Healthcare clinic in Whitefish, Mont. “If these medically unsound restrictions are reinstated, I wouldn’t be able to prescribe the safe, most common method of abortion to my patients that I have offered for many years. My patients in the largely rural state of Montana will struggle to travel hundreds of miles to get mifepristone in person. These restrictions have nothing to do with medicine or the safety of patients.”
All Families Healthcare is the only abortion provider in northwestern Montana and its sole clinician is an advanced practice registered nurse who would be unable to prescribe mifepristone to her patients under the appellate court’s April order.
Nicole Smith, executive director of Blue Mountain Clinic in Missoula, Mont., said, “The legal battle over mifepristone is causing chaos for our clinics and widespread confusion and fear among those who need an abortion. Montana is an island of abortion access in the northwest mountain region. We take care of patients from both Montana and our neighboring states who already face nearly insurmountable odds to receive essential abortion care. These restrictions perpetuate harm, stigma, and create unnecessary barriers to a medication that is safer than penicillin or Tylenol. It is time to end this ideologically driven government interference in the practice of medicine.”
The complaint explained why medication abortion access is so important. “Medication abortion allows people to forgo the physical contact and vaginal insertions of a procedural abortion, which may be particularly important for survivors of sexual violence and people experiencing gender dysphoria.”
It also argued that telemedicine abortion can “eliminate the exposure risks inherent in in-person clinic visits, particularly in light of the persistent and escalating violence and harassment at clinics known to provide abortion.”
The complaint described the harms caused by delayed access to abortion healthcare: “Each day a person remains pregnant means they continue to experience the symptoms, risks, and potential complications of pregnancy. Pregnancy—even when uncomplicated—stresses the body, causes physiological and anatomical changes, and affects every organ system. Pregnancy can also worsen underlying health conditions, many of which are common, such as diabetes and hypertension.”
The complaint detailed the harms of forced childbirth, including significant risks resulting from systemic discrimination and inequitable access to healthcare. “Every pregnancy-related complication is more common among people having live births than among those having abortions. Vaginal delivery can result in trauma to the pelvic floor and other significant injury. And, for the approximately one-third of pregnancies ending in a caesarean section (C-section), patients will undergo a major abdominal surgery that carries risks of infection, hemorrhage, and damage to internal organs. Pregnancy also has potentially long-term physical, emotional, and mental effects on a person who goes through childbirth, sometimes persisting well after birth.”
It noted that the United States has one of the highest maternal mortality rates among wealthy democracies, especially for Black women, who are three to four times more likely to die of a pregnancy-related death in the United States, and Indigenous women, who are 2.3 times more likely than white women.
Forced pregnancy and childbearing have long-term impacts on a person’s educational and economic futures, and their ability to shape their lives. “People who are denied a wanted abortion are more likely to experience economic insecurity and raise their existing children in poverty,” according to the complaint. “The financial impacts of being denied an abortion are as large as or larger than being evicted, losing health insurance, or being hospitalized.”
The plaintiffs argued that FDA restrictions on mifepristone also violate women’s dignity and autonomy. “The ability to make decisions about whether to continue or end a pregnancy, and by what method, is critical to a person’s dignity and autonomy. Continued enforcement of the [FDA restrictions on mifepristone] perpetuates harmful and unnecessary barriers that make it more difficult to access essential healthcare and interferes with this decision-making.”
The complaint concluded, “From the very beginning, FDA has overregulated mifepristone in ways that are unjustified and discriminatory. But even as decades of data has accumulated showing mifepristone to be one of the safest medications available in the United States, FDA has continued to subject mifepristone to uniquely burdensome restrictions with increasingly little reason for doing so. These restrictions are already irrational, but in light of the recent chaos surrounding mifepristone, they have also become intolerable and incompatible with Plaintiffs’ ability to meet the needs of their patients.”
The plaintiffs asked the court to order the FDA to remove the REMS restrictions or, alternatively, to enjoin the FDA from altering the current availability of mifepristone.
“We are tired, and we are angry, and we will not compromise or sit idly by as anti-abortion opportunists continue to attempt to block the safest, most effective, and preferred method of medication abortion in this country,” said Amy Hagstrom Miller, president & CEO of Whole Woman’s Health and Whole Woman’s Health Alliance. “Our patients deserve every single option that is available to them as they are making these choices for themselves and their families.”
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