Using Science and Evidence to Push FDA to Review Mifepristone REMS


Using Science and Evidence to Push FDA to Review Mifepristone REMS

Mifepristone with misoprostol is a safe, effective way to provide abortion and early pregnancy loss (EPL) care. Yet, the US Food and Drug Administration (FDA) heavily and unnecessarily regulates mifepristone under a Risk Evaluation and Mitigation Strategy (REMS). These restrictions limit where and who can provide medication abortion and EPL care; for example, mifepristone must be dispensed in a health care facility by a certified clinician, it cannot be mailed or dispensed in a retail pharmacy. A federal court temporarily suspended this in-person dispensing requirement for the duration of the pandemic. This allowed clinicians to mail medications directly to patients and to expand telehealth care for medication abortion. In May 2021, the FDA announced that it would undertake a full scientific review of the mifepristone REMS. 

The journal Contraception has just published a Special Issue on the mifepristone REMS that brings together a multitude of evidence and perspectives on the implications of removing mifepristone from REMS. This Special Issue not only demonstrates that FDA regulation of mifepristone creates unnecessary and harmful barriers to care, but it will be directly part of the package of evidence that scientists will examine as part of the mifepristone FDA REMS review. 

We are proud that our study, “US clinicians’ perspectives on how mifepristone regulations affect access to medication abortion and early pregnancy loss care in primary care” is part of the powerful special issue going to the FDA for review. Here, we explore primary care clinicians’ experiences and stories trying to provide mifepristone, and the effects on their patients. We learned that the REMS created direct obstacles to providing care. When mifepristone is inaccessible in primary care, patients are harmed. Their continuity of care is disrupted, they experience unnecessary and invasive procedures, they must manage multiple appointments and delays in care, and they receive less effective EPL care. 

“Patients have come to me wanting medical management of miscarriage or medical abortion, and I have had to turn them away and send them to other practices… stigmatizing their experience, and sending the message that management of their pregnancy and fertility is not part of primary care… I remember a patient sitting in my office, wanting a medical abortion from her trusted midwives and saying, how is it possible you can’t provide me with this service?” 

We welcome the FDA’s comprehensive review of the mifepristone REMS, and look forward to a decision based in science and evidence. While lifting the REMS is key to expanding access to mifepristone, it is crucial that we continue to demand and fight for policies to enhance reproductive autonomy and justice. We must dismantle oppressive state laws that chip away at reproductive rights, repeal the Hyde Amendment, pass the Women’s Health Protection Act, train and support all primary care clinicians to provide comprehensive reproductive health care, and create an environment where people can raise their families with dignity, free from violence and oppression. Only then can we have true reproductive freedom.  

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