Judge Kacsmaryk is poised to redefine the withdrawal method: FDA interuptus should alarm everyone

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By Robin Strongin, Health Policy Director

Bill Tompkins

Here we go, again.

Up until the Dobbs decision in 2022, Roe v Wade had been the law of the land since 1973.

Up until today, women didn’t have to worry that mifepristone, approved by FDA in 2000, would be available as a safe and effective and legal way to end an early pregnancy.

But, Texas Federal Judge Matthew Kacsmaryk, who has been vehemently anti-choice his entire life, is the judge who will decide whether to issue a preliminary injunction ordering FDA to withdraw its longstanding approval of mifepristone, the first pill in the two-drug medication abortion regimen.

Women, and their health providers, stand at a crossroads.  All women, not just those in Texas.

For some, it’s not enough that Roe was overturned in 2022.  Back in November 2022 the Alliance Defending Freedom, a conservative legal group, filed a lawsuit on behalf of antiabortion medical organizations and doctors.  At issue is the FDA’s approval of mifepristone, otherwise known as the medication abortion pill.  The plaintiffs, led by the Alliance for Hippocratic Medicine, have asked the judge to issue a preliminary injunction ordering the FDA to withdraw mifepristone.

Photo: Robyn Beck / AFP via Getty Images

This is unchartered territory.  The court is being asked, for the first time, to basically overturn the approval of a drug.  A drug that has been safely used for decades by over 5.6 million[i] women.  The drug regimen terminates pregnancies successfully 99.6% of the time, with a 0.4% risk of major complications, and an associated mortality rate of less than 0.001 percent (0.00064%).[ii]

This case, and several others that have been brought forward on medication abortion, raise questions about the role of the courts in reviewing the FDA’s findings about a particular drug.  This is chilling. Not only for the women who rely on this medication, but this case has the potential to set up an extremely alarming precedent for other FDA approved drugs.

And it’s dangerous territory for women and their health providers.  According to a court filing, FDA stated that overturning its approval of mifepristone would “cause significant harm, depriving patients of a safe and effective drug that has been on the market for more than two decades.”

Should Judge Kacsmaryk rule in favor of the plaintiffs, over half the abortions in the US could come to a halt—this includes abortions in states where abortion rights are (still) protected.  This case is expected to find its way to the Supreme Court—to the same justices who overturned Roe v Wade.

Through a coordinated strategy to take away women’s reproductive rights, advancing abortion bans—at the federal level, at the state level, and through the courts, results in confusion, fear, and poor health outcomes.

Fortunately, experts seem to agree that if the worst were to happen, and the preliminary injunction is granted (and remain in place following the inevitable appeals), there are several options that could allow for the continuing supply of the drug and for providers to continue prescribing.

For example, some abortion providers are planning to provide only the second abortion medication, misoprostol, which is used safely on its own in many countries, though it does have more side effects than mifepristone.

Earlier this week, Governor Gavin Newsom (D-Calif) announced that California state government would no long do business with Walgreens because of their decision that it won’t sell mifepristone in states where Republicans have threatened legal action, even in those states where abortion remians legal.

All of this is happening during Women’s History Month.  But, knowledge is power. According to the Guttmacher Institute, a leading research and policy organization committed to advancing sexual and reproductive health and rights worldwide,  “Since its approval, medication abortion has been used over four million times and has become so widely accepted by patients and providers that it now accounts for more than half of all US abortions—492,210 of the 930,160 abortions (53%) provided in 2020 were done with abortion pills.”

According to the Guttmacher researchers, the impact of eliminating access to medication abortion would differ greatly state to state, but could be especially promounced in rural counties and regions of any state….These 10 states could experience the most severe impact:

Colorado, Georgia, Indiana, Iowa, Maine, Montana, New Mexico, Pennsylvania,Vermontand Washington.

Guttmacher created an interactive map, capturing abortion-related policies and data, categorizing states from the most restrictive to the most protective.

On the map, viewers can also see demographic information and key abortion statistics. The data for women of reproductive age* in each state include:

  • Age-groups and race/ethnicity
  • Proportion living below 200% of the federal poverty level
  • Types of health insurance used
  • Proportion born outside the United State

Abortion-related statistics for each state include:

  • Number and rate of abortions provided
  • Number of clinics that provide abortions
  • Average driving distance to the nearest abortion clinic

The new interactive map is available here.

*The use of “women” to refer to the population of people potentially impacted by abortion policies reflects the terminology in the US census, from which many of our data points are drawn. We recognize that gender identities are diverse and not everyone who needs an abortion may identify as a woman. We reflect that reality in our language where we can, while also accurately describing the underlying data.

[i] Mifepristone US Post-Marketing Adverse Events Summary through 6/30/2022; TTT #2022-2468.  NDA 020687.  ANDA 091178. www.fda.gov

[ii] Mifepristone US Post-Marketing Adverse Events Summary through 12/31/2018; RCM #2007-525.  NDA 20-687.  www.fda.gov

National Consumers League applauds FDA’s decision increasing access to Mifepristone (the “abortion pill”)

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January 5, 2023

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, 202-823-8442

Washington, D.C. – The Food and Drug Administration (FDA)’s decision this week to lift a major barrier blocking access to medication abortion care marks an important step forward for women.  Mifepristone is a drug that blocks the hormone needed for a pregnancy to continue. Mifepristone, when used together with another medicine called misoprostol, is used to end a pregnancy through ten weeks gestation.  And it is safe.

The FDA posted the following on its website: “Mifepristone is safe when used as indicated and directed and consistent with the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program. The FDA approved Mifeprex more than 20 years ago based on a thorough and comprehensive review of the scientific evidence presented and determined that it was safe and effective for its indicated use.  As of 2016, it can be used for medical termination of pregnancy up to 70 days of gestation.  The FDA’s periodic reviews of the postmarketing data for Mifeprex and its approved generic have not identified any new safety concerns with the use of mifepristone for medical termination of pregnancy through 70 days gestation. As with all drugs, the FDA continues to closely monitor the postmarketing safety data on mifepristone for the medical termination of pregnancy.”

NCL urges continuous attention on this issue. While FDA moved things forward by expanding access, too many people remain without care options because they live in states that ban telehealth for medication abortion or have banned abortion outright.

FDA’s lifting of the in-person dispensing requirement and establishing a new program to certify both brick-and-mortar and mail-order pharmacies to dispense mifepristone is a turning point for so many, especially young women and women in abusive relationships who may not have the privacy to receive medication by mail.

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About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization.  Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad.  For more information, visit https://nclnet.org.

Guest Blog: Urgent push to get the Senate to pass the Pregnant Workers Fairness Act by end of year

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By Robin Strongin

Pregnancy discrimination in the workplace is real and it’s dangerous.  But, if the Senate acts quickly, it can pass S. 4431, the Pregnant Workers Fairness Act (PWFA) which provides reasonable accommodations for pregnant and postpartum workers.

The legislation, which has already passed in the House, enjoys strong bipartisan support and has garnered wide-ranging support from business associations, the US Chamber of Commerce, labor unions, faith organizations, civil rights organizations, maternal health groups, and others.  The US Conference of Catholic Bishops has stated that “These and other efforts to protect pregnant workers and new mothers should be applauded as they demonstrate a respect for life, family, and the dignity of workers.”

NCL stands with these organizations in urging the Senate to pass the legislation.  Pregnancy discrimination in the workplace is not only medically dangerous, but disruption to a woman’s career hurts her earning power and has implications for the labor supply.  More than 85 percent of women will become mothers at some point in their working lives, the majority of whom cannot afford not to work.

Despite passage of the federal Pregnancy Discrimination Act (PDA) of 1978, employer bias against pregnant women still exists, especially when it comes to employers providing reasonable accommodations to pregnant workers.

In early February 2022, the Bipartisan Policy Center and Morning Consult conducted a survey of 2,200 adults on the prevalence of pregnancy discrimination in the workplace. The survey found that “pregnancy discrimination is common across race, incomes, and other demographics, causing fear about informing employers about a pregnancy and leading many pregnant workers to consider a career change. These trends are particularly elevated among younger women and those who are currently working.”

Key Results:

  • Nearly 1 in 4 (23%) mothers have considered leaving their jobs due to a lack of reasonable accommodations or fear of discrimination from an employer during a pregnancy.
  • 1 in 5 mothers (20%) say they have experienced pregnancy discrimination in the workplace.
  • Adults are witnessing pregnancy discrimination in their workplaces.
  • Over 1 in 5 mothers have been afraid to tell an employer about a pregnancy.
  • A comparable portion of adults report that their partner or spouse has experienced pregnancy discrimination at work.

In their November 10, 2022 letter to the Senate Majority and Minority Leaders, urging swift passage of the Senate bill, the bipartisan members underscored what pregnancy discrimination looks like, and the terrible toll it takes:  …”a warehouse employee in Tennessee who suffered a miscarriage after lifting heavy boxes and being denied light duty; a retail worker in Kansas who was fired because she needed to carry a water bottle to stay hydrated, and a hardware assembler in Ohio who was terminated after her doctor recommended she not lift more than 20 pounds.”

Advocates are raising the alarm: if the Senate doesn’t enact the bill by the end of this year, opposition from Republicans over a lack of religious exemptions could jeopardize the passage of the legislation as Republicans take over the House.

The bill that passed the House did so with a strong bipartisan vote of 315 – 101.  And the Senate bill enjoys strong bipartisanship as well, according to Senate HELP Chair, Patty Murray (D-WASH), who is working across the aisle to get it passed.

If a stand-alone vote in the Senate doesn’t materialize, backers of the bill are considering its inclusion in the year-end spending package. Sen. Bill Cassidy (R-LA) warned, “The clock is ticking… This is a bipartisan bill that’s pro-mothers, pro-healthy pregnancies, and pro-workers,”…”Let’s get it through the Senate by the end of the year.”

NCL denounces today’s SCOTUS ruling overturning Roe v. Wade

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June 24, 2022

Media contact: National Consumers League – Melody Merin, melodym@nclnet.org, (202) 207-2831

Washington, DC— Almost 50 years since the Supreme Court ruling in 1973, Roe v. Wade, which guaranteed a woman’s constitutional right to an abortion, the protections provided by Roe were overturned today by the Supreme Court of the United States (SCOTUS). The ruling is a devastating blow to women, girls, and their families who have long fought for equal access to reproductive health services – health services which includes access to safe abortion, says the National Consumers League (NCL).

“Many women will suffer and will suffer unnecessarily from this egregious ruling by SCOTUS,” says Sally Greenberg, Executive Director of NCL. “This decision is an attack on poor women or low-income woman, who represent 75% of abortion patients,” according to the Guttmacher Institute, a research group that supports abortion rights.

The final opinion is strikingly similar to the draft that was leaked in May of this year and authored by Justice Samuel Alito. In the opinion, Alito writes, “It is time to heed the Constitution and return the issue of abortion to the people’s elected representatives.”

In the wake of this June 24 ruling, 26 states are expected to ban all or nearly all abortions.

Justice Clarence Thomas, in his concurring opinion overturning Roe v. Wade, laid out a vision that fomented fears about what other rights could disappear: the same rationale that the Supreme Court used to declare there was no right to abortion, he said, should also be used to overturn cases establishing rights to contraception, same-sex consensual relations and same-sex marriage.

In their joint dissent, the three liberal justices of the court, argued that the ruling will affect “countless life decisions.” They also noted that, “It says that from the very moment of fertilization, a woman has no rights to speak of.”

“NCL applauds responses from many employers, including JPMorgan Chase, which is clarifying its health care benefits in the wake of the Supreme Court overturning Roe v. Wade on Friday, saying that abortion has long been a covered service for the bank and starting in July will be included under the company’s health care travel benefit,” says Greenberg. “We applaud Levi Strauss & Co — the 169-year-old jean company — stands strongly against restricting access to abortion and said it will continue to protect employees — making sure they have access to the care they need regardless of where they live.

NCL also thanks officials in many states and the District of Columbia that have pledged to provide abortion access and safe havens including New Hampshire, Michigan, New York governors along with New York Attorney General Letitia James and DC Mayor Muriel Bowser.

In his address to the nation today, President Joe Biden expressed his disappointment over the SCOTUS ruling: “This is a sad day for the country in my view, but it doesn’t mean the fight is over.” He also added that his administration will use all its appropriate lawful powers and that “Congress must act.” He went on to say, “with your vote, you can act.”

NCL believes that women’s reproductive rights is fundamental and must be protected; this radical decision by the Supreme Court is vastly out of step with American public opinion and a disastrous for women’s rights and freedoms.  We will continue to advocate for federal, state and local protections for women across the country, in keeping with NCL’s long history of championing the rights of women and children, especially those among us who are most vulnerable.

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About the National Consumers League (NCL) 

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

NCL backs the Pregnant Workers Fairness Act to curtail workplace discrimination

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June 21, 2022

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, (202) 207-2832

Washington, DC— The National Consumers League (NCL) believes it is imperative that the Pregnant Workers Fairness Act (H.R. 1065), introduced by Representative Jerrold Nadler (NY-10), is enacted by Congress. In the uphill battle for equity in the workplace, NCL views H.R. 1065 as essential to protecting pregnant workers against unjustly losing their jobs and ensuring they receive pregnancy and post-partum accommodations to stay healthy.

Despite the steady decline of births in the United States since 2016, the number of federal pregnancy discrimination cases filed has steadily risen 67% from 2016-2020; and lawsuits are projected to set a new annual record this year. Workers lose approximately two thirds of the cases filed due to gaps in the current legal framework. H.R. 1065 will close loopholes in the Pregnancy Discrimination Act which requires pregnant workers to demonstrate that other workers are benefiting from comparatively similar accommodations before gaining approval from their employe

Women of color are more likely to work in physically demanding jobs, which also places the baby at  increased risk for preterm birth, low-birth weight, preeclampsia, birth defects, and more. While these health problems can be severe, long-term, and even deadly, studies illustrate how low-cost and basic accommodations for pregnant and postpartum workers can significantly reduce their risk. These include providing access to a chair to decrease time spent standing and basic accommodations for breastfeeding parents, such as a private space and additional break time to pump.

NCL strongly supports H.R. 1065. It will ask employers to provide reasonable accommodations for workers affected by medical conditions relating to pregnancy and childbirth. This will not only reduce health-related risks, but also improve workers’ economic security by safeguarding their jobs, income, health insurance, their baby’s health and more. Furthermore, by directly targeting discriminatory employment practices, H.R. 1065 represents a strong step in addressing sexism and racism in the workplace.

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About the National Consumers League (NCL) 

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

NCL applauds federal funding for maternal health in 2022 appropriations

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March 18, 2022

Media contact: National Consumers League –  Katie Brown, katie@nclnet.org, (202) 207-2832

Washington, DC— The National Consumers League applauds the passage of the 2022 omnibus appropriations act. The appropriations bill, signed into law, includes over $1 billion in federal funding to support critical maternal health provisions needed to address the nation’s alarming maternal mortality rates.

We are pleased that many provisions of the Black Maternal Health Momnibus Act of 2021 were included in the FY 2022 appropriations bill. The new law provides a significant increase in funding for the CDC’s safe motherhood & infant health programs. This additional support will help to identify drivers of maternal death rates in the states and expand evidence-based programs and interventions at hospitals and birthing facilities across the nation. The bill also includes a significant funding increase to the Maternal and Child Health Block Grant, which will assist state and local health entities in providing the essential health and social services that our most vulnerable birthing people and babies need.

Provisions from the Maternal Health Quality Improvement Act were also included in the fiscal year 2022 omnibus appropriations bill. These provisions provide funding that supports health professional schools to train future health care professionals about perceptions and biases in maternal health, which currently contribute to inequities in maternal health outcomes. In addition to racial bias, it is critical to invest in diversifying and expanding the perinatal workforce to include nurses, doulas, behavioral health professionals, and other practitioners. In a recent blog post, NCL Health Policy Associate Milena Berhane discusses the importance of diversifying the workforce and the negative impacts of racial bias on the quality of care for racial and ethnic minorities.

We recognize that perinatal suicides, which occur during pregnancy or up to one year postpartum, are a leading cause of maternal mortality in the United States. We are pleased that this appropriations act provides increased federal funding for maternal mental health programs. The additional funding will be critical in expanding access to community-based treatment and recovery services for pregnant people and new mothers who struggle with mental health or behavioral health conditions. The spending bill also funds additional necessary mental health resources, by increasing funding for the 24/7 maternal mental health hotline that is available to pregnant people and new mothers.

NCL applauds Congress for providing funding for critical maternal health provisions within the FY22 Omnibus bill. We will continue to advocate for the passage of additional maternal health provisions in future legislation and spending bills until we end the maternal mortality crisis in our nation.

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About the National Consumers League (NCL) 

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

What California is doing to lower maternal mortality

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Nissa ShaffiThe United States currently has the worst maternal mortality rate in the developed world, at 26.4 deaths per 100,000 live births, compared to 9.2 in the United Kingdom, 8 in France, and 5.5 in Australia. To put this in perspective, the United States currently has a higher maternal mortality rate than Saudi Arabia and Libya and is barely better than Mexico, Iran, and Russia. An even more devastating reality is the maternal mortality rate among black women, who are 243 percent more likely to die from pregnancy- or childbirth-related causes than women of any other race in America.

There is some good news amid these grim numbers. The state of California has successfully worked in collaboration with public and private healthcare stakeholders to decrease the maternal mortality rate to seven deaths per 100,000 live births.

In 2006, the California Department of Public Health (CDPH) and the California Maternal Quality Care Collaborative (CMQCC) worked together to assemble a multidisciplinary committee of clinical experts to investigate this epidemic. This committee’s focus was to determine the causes of maternal deaths and the demographics of women most affected, along with identifying opportunities to turn the numbers around.

Within the first two years of its launch, the committee was able to identify placenta accreta and preeclampsia (pregnancy-induced high blood pressure) as the two most preventable causes of maternal mortality.  Placenta accreta is a condition in which the placenta affixes to the uterine wall and fails to separate postpartum, which results in severe obstetric hemorrhaging. Upon discovering a correlation between the rise in cesarean sections (C-sections) and placenta accreta cases, the CMQCC sought to reduce the number of C-sections that were medically unnecessary.

Additionally, the CMQCC revamped California’s hemorrhage guidelines to help make childbirth safer for mothers in the state. As a result, California has created a state model that has resulted in a dramatic decrease in maternal mortality, while the rest of the country continues to experience an increase in rates.

California has set an example for the rest of the country. Other states would do well to take a page from its example and turn around this alarming trend of increased maternal fatalities. In addition, a bill currently being voted on in Congress, the Maternal Health Accountability Act (S.1112), would be a federal remedy to help address this issue. The bill would require states to monitor and assess pregnancy-associated deaths and develop appropriate measures to improve the quality of maternal care. We should all ask our members of Congress to help pass the Maternal Health Accountability Act (S.1112), a bipartisan bill that could potentially save countless lives and reverse the damaging trend of maternal mortality in the United States.