Skip to content Skip to search

Republish This Story

* Please read before republishing *

We’re happy to make this story available to republish for free under an Attribution-NonCommercial-NoDerivatives Creative Commons license as long as you follow our republishing guidelines, which require that you credit The 19th and retain our pixel. See our full guidelines for more information.

To republish, simply copy the HTML at right, which includes our tracking pixel, all paragraph styles and hyperlinks, the author byline and credit to The 19th. Have questions? Please email [email protected].

— The Editors

Loading...

Modal Gallery

/
Sign up for our newsletter

Menu

  • Our Mission
  • Our Team
  • Latest Stories
  • Search
  • Upcoming Events
  • Contact Us
  • Newsletter
  • Donate
  • Work With Us
  • Fellowships
    • From the Collection

      Changing Child Care

      Illustration of a woman feeding a baby a bottle
      • 1 in 4 parents report being fired for work interruptions due to child care breakdowns

        Chabeli Carrazana · February 2
      • Washington, D.C., offers financial relief to local child care workers

        Orion Rummler · September 20
      • As climate change worsens hurricane season in Louisiana, doulas are ensuring parents can safely feed their babies

        Jessica Kutz · May 5
    • From the Collection

      Next-Gen GOP

      Illustration of a woman riding an elephant
      • Mayra Flores’ victory set a record for women in Congress. It also reflects the growing visibility of Republican Latinas

        Candice Norwood · June 21
      • A banner year for Republican women

        Amanda Becker · November 11
      • Republican women could double representation in the U.S. House

        Amanda Becker · November 4
    • From the Collection

      On The Rise

      Illustration of three women marching
      • Can Cheri Beasley build a winning coalition in North Carolina?

        Candice Norwood · October 11
      • Los Angeles has never elected a woman mayor. Karen Bass hopes to change that.

        Nadra Nittle · September 8
      • Judge J. Michelle Childs is confirmed to D.C. appeals court

        Candice Norwood · July 20
    • From the Collection

      Pandemic Within a Pandemic

      Illustration of four people marching for Black Lives Matter with coronavirus as the backdrop
      • Some LGBTQ+ people worry that the COVID-19 vaccine will affect HIV medication. It won’t.

        Orion Rummler · November 23
      • Why are more men dying from COVID? It’s a complicated story of nature vs. nurture, researchers say

        Mariel Padilla · September 22
      • Few incarcerated women were released during COVID. The ones who remain have struggled.

        Candice Norwood · August 17
    • From the Collection

      Portraits of a Pandemic

      Illustration of a woman wearing a mask and holding up the coronavirus
      • For family caregivers, COVID is a mental health crisis in the making

        Shefali Luthra · October 8
      • A new database tracks COVID-19’s effects on sex and gender

        Shefali Luthra · September 15
      • Pregnant in a pandemic: The 'perfect storm for a crisis'

        Shefali Luthra · August 25
    • From the Collection

      The 19th Explains

      People walking from many articles to one article where they can get the context they need on an issue.
      • The 19th Explains: What we know about Brittney Griner’s case and what it took to get her home

        Candice Norwood, Katherine Gilyard · December 8
      • The 19th Explains: Why the Respect for Marriage Act doesn’t codify same-sex marriage rights

        Kate Sosin · December 8
      • The 19th Explains: Why baby formula is still hard to find months after the shortage

        Mariel Padilla · December 1
    • From the Collection

      The Electability Myth

      Illustration of three women speaking at podiums
      • Mayra Flores’ victory set a record for women in Congress. It also reflects the growing visibility of Republican Latinas

        Candice Norwood · June 21
      • Stepping in after tragedy: How political wives became widow lawmakers

        Mariel Padilla · May 24
      • Do term limits help women candidates? New York could be a new testing ground

        Barbara Rodriguez · January 11
    • From the Collection

      The Impact of Aging

      A number of older people walking down a path of information.
      • From ballroom dancing to bloodshed, the older AAPI community grapples with gun control

        Nadra Nittle, Mariel Padilla · January 27
      • 'I'm planning on working until the day I die': Older women voters are worried about the future

        Mariel Padilla · June 3
      • Climate change is forcing care workers to act as first responders

        Jessica Kutz · May 31
    • From the Collection

      Voting Rights

      A series of hands reaching for ballots.
      • Connecticut voters approved early voting. Here’s how their new secretary of state wants to make it happen.

        Barbara Rodriguez · February 13
      • Women lawmakers in Minnesota are in the vanguard of the democracy movement

        Barbara Rodriguez · February 3
      • Election workers believe in our system — and want everyone else to, too

        Barbara Rodriguez, Jennifer Gerson · November 8

    View all collections

  • Explore by Topic

    • 19th Polling
    • Abortion
    • Business & Economy
    • Caregiving
    • Coronavirus
    • Education
    • Election 2020
    • Election 2022
    • Election 2024
    • Environment & Climate
    • Health
    • Immigration
    • Inside The 19th
    • Justice
    • LGBTQ+
    • Military
    • Politics
    • Press Release
    • Race
    • Sports
    • Technology

    View All Topics

Home
  • Our Mission
  • Our Team
  • Latest Stories
  • Search
  • Upcoming Events
  • Contact Us
  • Newsletter
  • Donate
  • Work With Us
  • Fellowships

We’re an independent, nonprofit newsroom reporting on gender, politics and policy. Read our story.

The 19th News(letter)

News from reporters who represent you and your communities.

Please check your email to confirm your subscription!

Submitting...

Uh-oh! Something went wrong. Please try again later.

Become a member

The 19th thanks our sponsors. Become one.

Photo illustration showing a hand holding Mifepristone pills.
(Lydia Chebbine for The 19th; Getty Images)

Health

Label change for mifepristone could reduce barriers to care for miscarriages, advocates say in petition to FDA

Regulations around mifepristone, a common drug used for medication abortion, make it difficult for miscarrying patients to access it. A new petition to the FDA asks for a label change to make it easier to obtain.

Jennifer Gerson

Reporter

Jennifer Gerson headshot

Published

2022-10-04 09:43
9:43
October 4, 2022
am

Share

  • Twitter
  • Facebook
  • Email

Over 40 medical and advocacy groups submitted a petition to the Food and Drug Administration (FDA) asking for miscarriage management to be added as a use case for mifepristone, a drug commonly used in medical abortions, and ease the restrictions around who can prescribe it. 

Groups including the American College of Obstetricians and Gynecologists (ACOG), SisterReach, Physicians for Reproductive Health and the Expanding Medication Abortion Access (EMAA) Project were behind the petition. The changes they asked for Tuesday would make the drug easier to access for people experiencing miscarriages as some doctors and pharmacies have become more reluctant to distribute it after the end of Roe v. Wade. 

Mifepristone taken in combination with misoprostol is the most effective regimen for the medical management of miscarriage and medication abortions. Patient access to this drug is currently limited because of both the absence of FDA approval of mifepristone explicitly for miscarriage management and because the drug’s Risk Evaluation and Mitigation Strategy (REMS), the set of restrictions around the drug set by the FDA, limits clinicians’ ability to prescribe mifepristone. 

The 19th thanks our sponsors. Become one.

One in 6 known pregnancies globally end in miscarriage, and in unrecognized pregnancies it occurs in about 25 percent of cases. As stated in the FDA petition, miscarriage is also more common among pregnant people who are Black, low income or exposed to environmental pollutants. 

From its initial FDA approval in 2000 until December 2021, mifepristone could be dispensed only to a patient in-person under supervision of a clinician who has received certification to prescribe it. Such regulations are in place because of mifepristone’s FDA labeling as a drug indicated for use in medication abortion. Because of this, many medical and advocacy groups say, there is a stigma attached to mifepristone — one that makes the drug harder to access for patients seeking abortion care and miscarriage management care alike. 

  • More from The 19th
    Vice President Kamala Harris speaks during the first meeting of the interagency Task Force on Reproductive Healthcare Access. President Biden can be seen tuning in remotely on a screen.
  • Education Department reinforces Title IX protections for abortion and pregnancy
  • It’s been 100 days since Dobbs. What has changed?
  • Sen. Tammy Duckworth’s IVF experiences are informing her positions on abortion

During the pandemic, the American Civil Liberties Union, on behalf of a group of medical providers, filed suit against the FDA asking that the REMS be lifted, as the in-person dispensing requirement of the REMS made mifepristone impossible to access during lockdown. They were ultimately successful, and patients were temporarily allowed to receive mifepristone by mail or from specially certified pharmacies and take it on their own at home. An FDA policy change in December 2021 made the temporary pandemic modifications to the REMS permanent.  

The groups petitioning the FDA say miscarriage management should be added to the mifepristone label because it is the most effective regimen for medical management of miscarriage and has been shown to be safe and effective for use in this case up through the first trimester, during which 80 percent of all miscarriages happen.

“The evidence is clear that mifepristone improves the outcomes of our patients who are experiencing pregnancy loss, minimizing the need for additional interventions during an already traumatic experience at a time when compassionate care is critical for their physical and emotional recovery,” said Dr. Maureen G. Phipps, chief executive officer of ACOG. 

Following the reversal of Roe, many states have passed new laws severely restricting, and sometimes fully banning, medication abortion, which uses the same medications — mifepristone and misoprostol — used in medical miscarriage management. Some states have made it illegal for mifepristone to be mailed, others have limited the window during which medication abortion may be utilized, and some states have moved to ban abortion pills outright.

Advocates say that people who need mifepristone for miscarriage also face the same increased risk of potential criminalization. Because people of color and low-income people are also the most likely to be punished or face jail time for seeking abortions, advocates for the label change say this change could help those who need to access mifepristone for miscarriage management without fear of criminalization. 

Kirsten Moore, the director of the EMAA Project, told The 19th that the current climate surrounding mifepristone access is one where “confusion plus criminalization equals chaos — which leads to cruelty.”

“The fact that some states are trying to criminalize an FDA-approved drug is something we cannot pretend isn’t happening and these attempts are shutting down the willingness of health care providers to offer this care, whether in the context of abortion or miscarriage, which is amping up the pressure that patients might face as they do their own risk calculus in seeking this care,” Moore said. “As an advocacy community, we needed to make mifepristone’s potential clear.”

While health care providers have used mifepristone off-label for miscarriage management for years, because of the REMS, not all providers can write a prescription for it. Moore said providers will often prescribe a misoprostol-only regimen for miscarriage management in the absence of being able to prescribe mifepristone easily, but patients must take a very large amount of that medication for it to work and experience severe cramping as a result. 

“The mifepristone-misoprostol regimen is simply more effective. … We know it’s more effective, we know it’s safe, and anyone going through this experience should be offered this care,” Moore said.

Medical intervention is needed in the case of missed or incomplete miscarriage, when the body has not expelled all of the pregnancy tissue on its own. Without this care, miscarriage can result in hemorrhage, sepsis or death. Studies have shown that medically managed miscarriages conclude faster than miscarriages that happen without any kind of medical or surgical threatmet — often within a few hours if not more than a few days, compared with up to eight weeks. People who start medication management of their miscarriage are less likely to require a later surgical procedure to empty the uterus. 

With the current labeling, though, patients often face hurdles in accessing this care.

This past January, Hannah (who asked that her name be withheld for privacy) was thrilled to learn that she was pregnant for the first time. The North Carolina resident and her partner immediately began planning the nursery and traded ideas on parenting philosophies in a Google document. Just weeks after first taking a positive at-home pregnancy test, Hannah suspected she might be miscarrying and went to the emergency room. 

Many medical tests later, the viability of Hannah’s pregnancy was determined inconclusive. She was told to go home and to “wait it out” and given the number for a clinic affiliated with the hospital to continue to evaluate the status of her pregnancy. 

Stories by experienced reporters you can trust and relate to.

Delivered directly to your inbox every weekday.

Please check your email to confirm your subscription!

Submitting…

Uh-oh! Something went wrong. Please try again later.

Just shy of 11 weeks pregnant, Hannah started to hemorrhage at home, and returned to the emergency room where she was treated, but her miscarriage still had not resolved on its own. Hannah asked for medication management to conclude her miscarriage and was shocked when she was told by the ER doctor that though she wished they could give that to her, they could not. She was not legally able to do so because she wasn’t an authorized provider of mifepristone as defined by the REMS.

The doctor, Hannah recalls, said “her hands were tied,” and referred Hannah to another clinic — a specialty family planning provider — who was legally able to prescribe the medication Hannah would need to complete her miscarriage. Hannah called that clinic to make an appointment, and had to wait another four days before she could be seen. Finally, Hannah was able to be seen by a provider there who confirmed that Hannah’s miscarriage was not complete, prescribing her mifepristone. 

“It was really deeply disappointing to have to continue to have to deal with the miscarriage when there could have a way to treat it given the harsh physical and emotional symptoms I was having,” Hannah said. “It could have been resolved four days earlier. That might not sound like a lot to someone not having a miscarriage, but to someone having one, that’s awful.” 

“I was really mourning this child we thought we were going to have and was no longer going to be entering our lives,” she continued. “I had to prolong the physical process of dealing with it all because, to my view, of a political agenda.”

Share

  • Twitter
  • Facebook
  • Email

The 19th News(letter)

News from reporters who represent you and your communities.

Please check your email to confirm your subscription!

Submitting...

Uh-oh! Something went wrong. Please try again later.

Become a member

Up Next

A vehicle drives past the Department of Justice building in Washington, D.C.

Health

Medical groups ask Justice Department to investigate threats against hospitals over gender-affirming care

Major medical groups want the DOJ to investigate threats against hospitals providing gender-affirming care for trans youth, sparked by online disinformation.

Read the Story

The 19th
The 19th is a 501(c)(3) tax-exempt organization. Our stories are free to republish in accordance with these guidelines.

  • Donate
  • Newsletter
  • Events
  • Search
  • Jobs
  • Fellowships
  • Contact Us
  • About Us
  • Community Guidelines
  • Membership
  • Membership FAQ
  • Major Gifts
  • Sponsorship
  • Privacy
  • Twitter
  • Facebook
  • Instagram