Mifepristone, a drug used in medication abortion, faces tighter restrictions than it has in years after a federal appeals court ordered a return to the rules that were put in place when the drug was approved by the US Food and Drug Administration in 2000.
In the decades since, research and clinical evidence has led to expanded options for the medication’s administration. The FDA has approved changes that extended its use from up to seven weeks gestation to 10 weeks, as well as allowing virtual dispensing and administration.
A reversal of these guidelines creates a complicated medical and legal landscape for medication abortion in the United States, and health care experts are uncertain about how things will play out.
Although the court ruling may make mifepristone harder to get, however, it is still legal to use in the US.
A recent poll from KFF found widespread confusion around medication abortion more than six months after the US Supreme Court issued the Dobbs decision, overturning Roe v. Wade and revoking the federal right to abortion. Nearly half of adults – including 2 out of 5 women of childbearing age – were unsure whether medication abortion was legal in their state.
“We are now in a post-Dobbs world. So it’s not only figuring out how to manage an FDA-approved medication, it’s figuring out how to manage an FDA-approved medication in a dramatically fractured national landscape of state laws around abortion,” said Kirsten Moore, director of the Expanding Medication Abortion Access Project.
“The intention is to create as much chaos and confusion in the system,” she said. “That’s going to lead to cruelty, because people will be turned away from care or think that they can’t get care.”
For now, one option for providers is to prescribe the drug “off-label,” which is legal and common practice. Even if the drug label on mifepristone is changed to reflect the regulations from the original FDA approval, with a maximum gestational age of 49 days, physicians can still prescribe it for later-term abortions.
One out of every 5 prescriptions that are written for any drug are for off-label use, according to the US Department of Health and Human Services’ Agency for Healthcare Research and Quality.
However, some parts of the mifepristone label are subject to a set of additional regulations from the FDA, known as a Risk Evaluation and Mitigation Strategy, or REMS.
“Think of it as an extra layer of safety checks for riskier medications that potentially could have side effects or issues,” said Dr. Jennifer Lincoln, an ob/gyn and executive director of Mayday Health, a nonprofit focused on education around reproductive health. “That sounds fine and good when it’s a really concerning medication, but it makes no sense for mifepristone, which we know is a remarkably safe drug.”
Bucking REMS requirements could have more severe consequences for providers. For mifepristone, some of the regulations that would fall under this category are the need for in-person dispensing and follow-ups. These restrictions could pose potentially significant barriers to telehealth, which has become an increasingly sought-after option.
“This is absolutely a health equity issue, and it will harm those who’ve already had difficult access,” Lincoln said. Telehealth has helped provide options for people seeking abortions in states where it is banned, as well as for those who don’t have the means to travel for an abortion.
Still, questions – and possible paths forward – remain.
Melissa Grant, chief operating officer for Carafem, a national provider of reproductive health services including a virtual abortion clinic, is confident that they will continue to find ways to provide care.
Shield laws in some states could offer workarounds, she said. Abortion laws have become more fractured since the Dobbs decision, and this may be an additional step down that path.
The new court ruling is also an unprecedented challenge to the FDA’s authority. A response from the federal agency could greatly affect what happens next.
The FDA had no comment on the issue Thursday.
Medical professionals emphasize the science behind the safe and effective use of mifepristone.
“Judges and lawmakers should not be substituting their own opinion for the experience, expertise, and authority of the U.S. Food and Drug Administration. Nor should they ignore the substantial weight of scientific evidence from hundreds of studies and millions of patients confirming the safety and effectiveness of mifepristone, which has been used for decades in both medication abortion and miscarriage management,” Dr. Jack Resneck Jr., president of the American Medical Association, said in a statement.
“The appellate court order, if allowed to stand, creates more barriers to care, harms patients and physicians, and exacerbates the maternal mortality crisis, especially for historically marginalized communities. It also opens a pandora’s box for similar politically motivated, unscientific attacks by judges with no medical or scientific training against the FDA’s scientific, evidence-based approvals of countless other medications.”