The Shadow
05.08.23 — Today, abortion providers in Virginia, Montana, and Kansas filed a federal lawsuit against the Food and Drug Administration (FDA) to protect access to mifepristone—one of the two drugs used in medication abortion. This lawsuit seeks a ruling similar to that in State of Washington v. FDA to protect mifepristone access in the three states involved while litigation proceeds. Currently, medication abortion accounts for more than half of all abortion care in the U.S. and most of those include mifepristone as part of a two-drug regimen. Today’s lawsuit was filed by the Center for Reproductive Rights as threats to mifepristone access loom large. It comes just two weeks after the Supreme Court temporarily blocked an unprecedented court order from Judge Matthew Kacsmaryk seeking to roll back access to mifepristone.
In today’s lawsuit, abortion providers argue that mifepristone is needlessly restricted by the FDA and that such barriers run counter to over 20 years of scientific evidence that the medication is safe and effective. The lawsuit also states that these restrictions have long been used as a tool by the anti-abortion movement to stigmatize and undermine access to medication abortion. The FDA has repealed some of these restrictions over time, including a requirement forcing patients to obtain mifepristone in person at a clinic and an outdated rule preventing certain trained providers from being able to independently prescribe the drug. However, many other barriers remain, and all of these restrictions only impede access to time-sensitive abortion care and threaten people’s health and well-being.
After the FDA appealed Judge Kacsmaryk’s order and sought emergency relief in April, the Fifth Circuit Court of Appeals attempted to reinstate restrictions from pre-2016. While the Supreme Court halted enforcement of these orders for now, abortion providers were repeatedly thrown into chaos throughout April with the accessibility of mifepristone volleying between multiple federal courts. The appeals court will soon hear that case on May 17, and if these burdensome restrictions are allowed to take effect or access to mifepristone is otherwise threatened, it could again cause the same chaos among abortion providers and patients and dramatically limit access to care. With this lawsuit, abortion providers are seeking to avoid future uncertainty, prevent further harm to their patients, and keep mifepristone accessible under the current regulations in their respective states.
“The anti-abortion movement has come for medication abortion access in every state in the country. We are suing on behalf of abortion providers in states where abortion access remains, but healthcare practitioners need protection for providing medication abortion. Anti-abortion extremists have gone so far as to seek to override the FDA’s scientific judgment decades ago that mifepristone is safe and effective,” said Nancy Northup, president and CEO of the Center for Reproductive Rights. “It is critical that abortion providers and patients obtain certainty in light of the chaos that is currently surrounding mifepristone.”
Mifepristone was approved by the FDA in 2000 and since that time, medication abortion has been used by nearly 5 million patients across the country. Numerous studies have repeatedly shown the safety and efficacy of mifepristone in the two-drug medication abortion regimen. Medication abortion accounts for more than half (54%) of all abortions in the U.S., and 98% of medication abortions in 2020 used the two-drug protocol.
Despite repeatedly concluding that mifepristone is one of the safest medications available in the U.S. based on decades of robust research, the FDA subjects the drug to outdated, medically unnecessary restrictions known as the Risk Evaluation and Mitigation Strategy (REMS). Leading medical and public health groups including the American Medical Association and the American College of Obstetricians and Gynecologists oppose such limits on mifepristone.
While many hurdles are still in place, the FDA eliminated several REMS restrictions after conducting a comprehensive review of the need, or lack thereof, of these restrictions. Most recently, the FDA expanded access to medication abortion by allowing patients to access mifepristone at pharmacies and through mail-order pharmacies with a prescription instead of obtaining the drug in person at a clinic. If previous restrictions are reinstated, it will prevent abortion providers in the lawsuit from mailing mifepristone and limit which providers can independently prescribe the drug. In Montana for example, All Families Healthcare is the only abortion provider in northwestern Montana and its sole clinician is an advanced practice registered nurse (APRN) who would be unable to prescribe mifepristone to her patients under the appellate court’s April order.
Quotes from Plaintiffs:
“Today, we are filing this case to seek protection for patients and providers in Virginia, Kansas, and Montana—key states in post-Roe abortion access. So much of the coverage of the Mifepristone lawsuits has focused on federal judges or the courts; for us this is about our patients who are forced to travel hundreds of miles to the nearest clinic and about abortion providers in key border states who are doing all we can to help them,” said Amy Hagstrom Miller, President & CEO of Whole Woman’s Health and Whole Woman’s Health Alliance. “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. Our patients deserve every single option that is available to them as they are making these choices for themselves and their families.”
“The recent attacks on Mifepristone’s legal status are nothing but bad politics,” said Rebecca Tong, Co-Executive Director of Trust Women in Wichita, Kansas. “The consequences of restricted access will be significant: our ability to meet the overwhelming demand for services will be challenged and patients will experience devastating wait times for appointments. All people should have meaningful local access to the fullest range of medical care supported by science—their ability to access quality care should not depend on where they live but on the principles of good medicine.”
“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. 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,” said Helen Weems, APRN and owner of All Families Healthcare clinic. “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, so I am fighting to protect Montanans and their ability to access evidence-based care.”
“The legal battle over mifepristone is causing chaos for our clinics and widespread confusion and fear among those who need an abortion,” said Nicole Smith, Executive Director of Blue Mountain Clinic. “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.”
This case was filed by the Center for Reproductive Rights on behalf of plaintiffs Whole Woman’s Health in Virginia; Trust Women in Kansas, and; All Families Healthcare and Blue Mountain Clinic in Montana.
