Mifepristone is a medication abortion drug that faces more restrictions now than in previous years. A federal appeals court has ordered a return of the rules in place in 2000 when the drug had been approved by the US Food and Drug Administration.
Since then, clinical and research evidence have led to a wide range of options for administering the medication. The FDA approved changes to the FDA that allowed for a longer use of this medication, from seven to ten weeks gestation.
Health care experts are unsure about the outcome of reversing these guidelines, which will create a complex medical and legal environment for medication abortions in the United States.
The US is not affected by the ruling.
KFF's recent poll found confusion about medication abortions more than six month after the US Supreme Court released the Dobbs ruling, which overturned Roe v. Wade. Nearly half of all adults, including two out of five women of childbearing years, were not sure if medication abortions were legal in their state.
We are now living in a post Dobbs era. It's not just about figuring out the best way to administer an FDA approved medication. It's also about figuring out what to do with an FDA approved medication when there are so many state laws that prohibit abortion.' Kirsten Moore is director of Expanding Medication Access Project.
She said that the intention was to cause as much confusion and chaos in the system as possible. "That will lead to cruelty because people are going to be turned away from the care they need or believe that they cannot get care."
For the time being, providers can prescribe the drug "off-label," which is a legal and common practice. Even if mifepristone's label is updated to reflect FDA regulations, including a maximum gestational period of 49 days for the FDA approval, doctors can still prescribe the drug.
According to the US Department of Health and Human Services Agency for Healthcare Research and Quality, one out of five prescriptions written for a drug is for an off-label usage.
REMS is the FDA's term for a set additional regulations that apply to certain parts of the label.
'Think about it as an additional layer of safety checks to ensure that riskier medications are not causing any side effects,' said Jennifer Lincoln, ob/gyn, and executive director of Mayday Health - a nonprofit focusing on reproductive health education. "That's fine when it comes to a medication that is really concerning, but it doesn't make sense with mifepristone which, as we know, is a very safe drug."
Providers could suffer more serious consequences if they do not comply with REMS. Some of the regulations for mifepristone would fall into this category, such as the requirement for in-person distribution and follow-ups. These restrictions may pose significant obstacles to telehealth. This option is becoming increasingly popular.
Lincoln stated that 'this is absolutely an issue of health equity, and will harm those who have already had a difficult access'. Telehealth is a great option for women who want to have an abortion in states that ban it, or for those without the financial means to travel.
Questions and possible future paths remain.
Melissa Grant, Carafem's chief operating officer, is confident in the company's ability to continue providing care.
She said shield laws in certain states may offer a workaround. Since the Dobbs ruling, abortion laws have been more fragmented. This may be another step in that direction.
This new court decision is also a challenge to FDA authority that has never been seen before. The response of the federal agency will have a major impact on what happens next.
The FDA did not comment on this issue Thursday.
Medical professionals stress the science behind safe and effective mifepristone use.
Judges and legislators should not substitute their opinion with the expertise, experience and authority of the U.S. Food and Drug Administration. They should also not ignore the weighty scientific evidence, gathered from hundreds of clinical studies and millions patients, that confirms the safety and efficacy of mifepristone. It has been used in medication abortion and miscarriage treatment for decades.
If the appellate court's order is allowed to stand, it will create more barriers to health care, harm patients and doctors, and worsen maternal mortality, particularly for historically marginalized groups. This opens the door to similar, politically motivated and unscientific attacks from judges without medical or scientific training on FDA's scientific and evidence-based approvals for countless other drugs.