July 2021

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.  

Legal Round Up: What a Year! 

2021 is on track to be the worst legislative session for abortion restrictions in decades. Since January, 549 abortion restriction bills have been introduced in 47 states, and 69 of them have been enacted.  Worst of all, in May the Supreme Court announced it would hear Dobbs v. Jackson Women’s Health, a case challenging a 15-week abortion ban in Mississippi. This ban is in direct violation of the precedent established by Roe v. Wade. A silver lining in all this: the FDA agreed to review its excessive restrictions on mifepristone, one of the medications used in medication abortion.

It is important to understand how these various cases, laws, and regulations impact clinicians and health care organizations providing reproductive health care. We thought we’d share some of the insight we shared with our clinician community.

 

Understanding the FDA’s upcoming review of the REMS restrictions on Mifepristone

 

• FDA imposes a Risk Evaluation and Mitigation Strategy (REMS) on fewer than 3% of the 20,000 drugs it regulates – and mifepristone is the only medication that patients are required to pick up in a clinical setting even though they do not have to take it in a clinical setting.
• During the pandemic, the ACLU went to court on behalf of the American College of Obstetricians and Gynecologists, SisterSong Women of Color Reproductive Justice Collective, the Council of University Chairs of Obstetrics and Gynecology, the New York State Academy of Family Physicians, and RHAP Network member Dr. Honor MacNaughton, challenging the REMS requirement that mifepristone be obtained in-person at a health center – because it exposed patients to entirely needless COVID-19 risks, with particular harm to communities of color.
• After a lot of back and forth, this past April, the FDA announced that it was suspending the mifepristone in-person requirements for the remainder of the COVID-19 public health emergency. Health care providers can now mail mifepristone, via approved pharmacies, to people needing the medication.
• In May, FDA announced that it was comprehensively reviewing the mifepristone REMS requirement.  This opens up the possibility that REMS restrictions on mifepristone will be lifted and would improve access to the medication for abortion and early pregnancy loss care.  We think the FDA will make a decision by the end of 2021.

Overview of the Jackson Women’s Health Supreme Court Case:

This lawsuit was brought by the Center for Reproductive Rights on behalf of Jackson Women’s Health, the sole abortion clinic in Mississippi, challenging 15-week abortion ban. The Supreme Court agreed to review the lower court decisions that struck down the ban based on 50 years of unbroken precedent affirming that states may not ban abortion before the point of viability. 

While we don’t know for sure what the Supreme Court will decide, this case will have huge ramifications on reproductive rights in our country. The Supreme Court will hear the case this fall and a decision is expected in late Spring of 2022.

We know that laws banning abortions don’t stop people from having them. They do make accessing abortion more expensive, complicated, and time-consuming. They do delay access to care further into a pregnancy. And they do disproportionately hurt those who already face barriers to accessing health care, including women, BIPOC, LGBTQI+ folks, young people, those living in rural communities, folks who are low-income, immigrants, and people with disabilities. 

If abortion becomes more restricted than it already is, or outright illegal in some states, accessing abortion care will be even more difficult for people that already have little to no access. More people will be forced to travel to states where abortion remains legal. Clinicians in these states need to be prepared to increase their capacity to avoid further delays of care – this means more clinics and most of all, more trained abortion providers. Our work training and supporting clinicians  to provide comprehensive reproductive health care and to speak openly about providing abortions and the reasons why they do so has never been more crucial. 

 

Telehealth Care for Medication Abortion 

During the COVID-19 pandemic, many health centers and clinicians rapidly transitioned and innovated in order to provide high-quality medication abortion care with minimal interpersonal interaction to protect against virus transmission. This involved forgoing ultrasound in patients without explicit need for it, counseling via telehealth, taking at-home pregnancy tests, offering remote follow-up care if patients desired, and even mailing the medications. While some of these changes began well-before the pandemic, the need for social distancing compelled more and more health centers to innovate rapidly.

Clinicians and academics began calling this kind of care “no-touch” or “no-test.” “No-touch” reflected the lack of physical contact in medication abortion care, stressing safety and reducing risks of virus transmission. “No-test” emphasized the simplicity. However, both messaging options also allow for negative assumptions and stereotypes about medication abortion care. For some people, medical tests are valuable tools for health care and touch is an important part of care, compassion, and healing. 

To destigmatize these innovations in medication abortion care, we renamed our resources from no-test/no-touch to “telehealth care for medication abortion.” This change came out of recommendations generated by a collaborative brainstorming process led by the EMAA project with over 55 organizations representing patient advocates, policy advocates, clinicians, and researchers. Putting “telehealth” language front and center allows the movement to increase the familiarity of telehealth, connect abortion care with general health care, reinforce safety and effectiveness of medication abortion care, and mainstream telehealth even after the pandemic.

We recognize, not all clinicians are able to provide telehealth care for medication abortion and/or to forgo ultrasound due to restrictive, unnecessary state laws banning this form of abortion care. These state laws are not based in science or evidence, and only harm patients by delaying and stigmatizing their health care. We cannot have true reproductive health equity, dignity, and freedom without dismantling these structural barriers to care. 

Meet Our Summer Interns!  

Join us in welcoming our new summer interns, Hayley and Marho!

Hayley Farless McMahon, Research Intern

Hayley (she/her) is joining us as our Research Intern. Hayley is a Master of Science in Public Health (MSPH) at Johns Hopkins Bloomberg School of Public Health. She is a proud first-generation college graduate with a degree in Cultural Anthropology and Global Health from Duke University. Originally from Tennessee, Hayley has specific research interests related to abortion access, stigma, and misinformation in the Southeast. Hayley will be helping us evaluate the impact of the Reproductive Health Access Network and generate recommendations on how to build Network leadership and engagement.

What sparked your passion for reproductive health care and justice?

I grew up in rural Appalachia in a low-income community, so I know how complicated it can be to access the healthcare you need. Add in the stigma that surrounds many forms of reproductive healthcare and things start to feel like an impossible obstacle course, especially for folks belonging to historically marginalized communities. My passion for reproductive justice is based on a really simple core value: All people deserve to live safe, healthy lives. That includes having the autonomy and resources they need to prevent pregnancy, end a pregnancy, give birth, and/or raise a child. 

In your new position at RHAP as Research Intern, what are you most excited about?

I’m most excited about the opportunity to hone my methodology skills! I feel like something I’ve really missed in the classroom, especially with Zoom school and everything, is getting hands-on experience with data analysis.

What do you like to do in your spare time?

I love to read (used bookstores are my weakness—the best kind of recycling!) and really enjoy wildlife photography. My husband, Bryan, and I love to travel, and we also have several pets (cats, geckos, and an axolotl) that we spend a lot of time with.

What are you currently reading/watching/listening to?

I just finished reading Mariame Kaba’s new book, We Do This ‘Til We Free Us, and absolutely recommend it!

Marho Avworo, RRASC Intern

Marho (she/her) hails from Southwest Houston, Texas and is currently a rising senior at Houston Baptist University. She hopes to graduate with a Bachelor’s Degree in medical humanities and concentration in pre-medicine. Her interest is to bridge the gap between family medicine and psychiatry, while helping communities gain access to partial and later, total health care. With her personal experience in watching African American women have a lack of access to doctors, starting with her mother, her passion increased in wanting to advocate for said population. She also works at a pharmacy and advocates for reproductive justice for patients without insurance. Marho will be supporting the Reproductive Health Access Network.

What sparked your passion for reproductive health care and justice?

With the past year, we have gotten to see so much injustice with how it relates to health care, injustice and discrimination, all around. As an aspiring family medicine/psychiatry physician, I discovered that knowing and studying medicine is only one aspect of the patient’s life; there are other factors that play a role as well. Also, I’m from Southwest Houston, and in the past year, I realized that there is a lack of access to physicians, either due to race, lack of income or whatever the case maybe. Therefore, I am interested and excited to see how I can help bridge the gap between the patients and physicians. 

In your new position at RHAP as the RRASC Intern, what are you most excited about?

As the RRASC Intern, I am very excited to work with an amazing group of people, learn from them, and impact others with the knowledge gained. I am also thrilled to see how the work we do in RHAP with the primary care physicians will impact patients directly. With this experience, I can prepare myself to be a better physician in the future and provide access to those who would not have it otherwise. 

What do you like to do in your spare time?

I love driving, so in the past year, I figured I could drive and make money at the same time by becoming a dasher for DoorDash. Also, I love spending with family, especially my mom. We watch movies and workout together as well. My mom has also shared a couple of recipes with me so I love cooking, as well. 

What are you currently reading/watching/listening to?

I’m currently reading a book called “House of Sticks”. It’s a memoir by Ly Tran. Also, I love afrobeats, so I listen to them always.