A Bad Medication Abortion Decision Threatens the Future Availability of Drugs in the U.S.

With an April 7 court decision, one judge has harmed women’s health and undermined trust in science-based drug approvals in the U.S.

By Liz Borkowski and Julia Strasser

When federal Judge Matthew Kacsmaryk suspended the Food and Drug Administration (FDA) approval of the drug mifepristone on April 7, he significantly jeopardized access to abortion. In addition to dealing an immediate blow to accessing an essential and time-sensitive health care service, this decision also upended a drug approval system that for decades has been based on scientific evidence and expert medical opinions. Kacsmaryk overshadowed a trusted system with the specter of a drug supply shaped by judicial fiat.

The lawsuit was filed in the U.S. District Court for the Northern District of Texas, but the April 7 decision pertains to mifepristone’s FDA approval nationwide. Kacsmaryk gave seven days for the government to appeal before the decision takes effect, and the fact that a federal judge in Washington state issued a conflicting ruling—ordering that FDA retain mifepristone access in the jurisdictions that brought that suit (17 states and the District of Columbia)—makes it possible the appeal will go directly to the Supreme Court rather than the Fifth Circuit. If a higher court fails to overturn Kacsmaryk’s ruling, this decision opens a Pandora’s box that could allow the availability of every drug in the U.S.—from vaccines to painkillers—to be based on politics rather than science.

This decision raises alarm for its enormous potential impact on women’s—and other individuals’—health, as well as the lasting effect it may have on the federal regulatory process. For mifepristone, the science on its safety and efficacy was substantial when FDA first approved the drug in 2000, and this evidence has only grown in the intervening years. (The New York Times recently collected and analyzed 101 studies on mifepristone, and the vast majority found no serious complications in more than 99 percent of those who took the drug.) However, from the drug’s initial approval process to the present, politically motivated attacks have threatened its availability and use.

In Alliance for Hippocratic Medicine v. FDA, antiabortion plaintiffs claimed FDA’s 2000 approval of mifepristone—which, used in combination with misoprostol, accounts for approximately half of all U.S. abortions—was improper because the agency fast-tracked it under a regulatory provision known as Subpart H. Although Subpart H does allow for fast-tracking certain drugs, FDA didn’t use it for that purpose with mifepristone. By the time FDA approved mifepristone, more than a decade of evidence demonstrated its safety and effectiveness. During the approval process, FDA used Subpart H to impose additional restrictions on how the drug could be dispensed, including requiring providers and patients to sign agreements before using it. Extensive evidence has demonstrated those restrictions are unnecessary for safety, and FDA has since relaxed some of them.

Medication abortion is safe, effective and very common. There were 492,210 medication abortions in 2020, representing 53 percent of all abortions in the U.S. The rate of serious adverse events is significantly lower than in continuing a pregnancy to term, especially for Black women, whose maternal mortality rate is more than double white women’s. Furthermore, in a post–Dobbs v Jackson Women’s Health Organizationenvironment, where clinics in a dwindling number of states must care for clients from across the country, offering medication abortion has allowed providers to serve more patients than they could via procedural abortions alone.

Following the Kacsmaryk decision, some providers might keep offering the mifepristone-misoprostol combination for medication abortion unless and until FDA formally withdraws its approval. Many will switch to a misoprostol-only regimen that’s used in countries where mifepristone isn’t readily available. This alternative regimen requires different dosing and timing, placing the onus on already burdened medical providers to change their clinical practices.

Updating procedures and trainings will mean taking time away from patient care. Some providers who currently offer medication abortion might simply stop doing so, as this legal issue adds to the growing toll of harassment and attacks they’ve faced in recent years; threats to abortion providers’ physical safety—which include arson and murder—had already increased by 125 percent from 2019 to 2020, even before the Dobbs decision. FDA can engage in the unnecessary exercise of reconsidering mifepristone in light of the decision, but in the meantime access to medication abortion is likely to drop.

Despite providers’ best efforts, after this decision we’re likely to see still more of what we started seeing in the immediate wake of Dobbs: people will have to spend more money, travel farther, and face more job and childcare challenges in order to get abortions. Those with the fewest resources—who, because of systemic racism, are disproportionately likely to be Black and brown women—will be unable to do so and will be forced to bear children against their will. Given this country’s shameful maternal mortality rate, this is quite literally a life-and-death decision.

Judge Kacsmaryk, who previously worked for a conservative Christian advocacy group, has substituted his judgment about mifepristone for that of the FDA experts who reviewed it, with severe consequences for public health. If his decision stands, no drug is safe from such politically motivated meddling. Drugs used in gender-affirming care will probably see court challenges, and contraception and routine vaccinations could also come under threat. Furthermore, public erosion of confidence in our system of government, already well on its way, will get a big push. FDA has been part of the regulatory system protecting public health for more than a century, and has a strong record of basing decisions on the available science and research at the time. If a single judge can now overturn a decision that was based on research and expertise, then the safeguards we count on are only dependable until a few individuals decide to take them away.

Access to reproductive health services already looks dramatically different across the U.S. than it did a year ago, but the damage from this decision could spread far beyond the critical issue of abortion. A higher court should overturn Judge Kacsmaryk’s misguided decision and prevent politics from overriding science-based decision-making.

The Global Impact of Period Poverty

Several animated, faceless, women of various races standing side by side

By: Maya Burke

Executive Summary

Period poverty is an issue that effects those who menstruate globally. When menstruating individuals lack the tools and facilities to safely manage their menstrual cycle, they lose their freedom to participate in activities that effect their livelihood, such as attending school and going to work. They face stigmatization in the form of cultural taboos and unjust norms. It is these taboos and norms that perpetuate the issue of period poverty and do not allow those who menstruate an equitable chance to participate in society. There have been efforts throughout the world aimed at providing that equitable chance to those who menstruate, through providing menstrual products at no cost, providing days off of work for menstrual leave, and reducing or eliminating taxes on products. What has not received enough emphasis, and what needs to be done in order for this issue to be taken seriously, involves addressing the stigmatization of menstruation. Recommendations are provided to the Commission on the Status of Women (CSW) regarding what action needs to be taken in order to address this issue. This includes unrestricted access to free menstrual products and safe sanitation facilities, as well as beginning to break down the stigma surrounding menstruation. This could be done through the requirement of sexual education with an emphasis on menstruation throughout public schools, as well as the inclusion of all individuals who menstruate, including, but not limited to, women, non-binary individuals, and transgender men, in the movement.

Context

Period poverty can be defined as an inadequate access to the tools needed to safely and effectively manage menstruation. This includes, but is not limited to, safe and sanitary toilets, menstrual products such as tampons or pads, proper waste management, and education about menstruation, as well as education missed while attending to period care (Michel 2022). Access to the tools to manage menstruation is an issue that effects about half of the global population, but goes largely ignored due to the stigma placed on periods in just about every society. Menstruating individuals are taught that this aspect of their existence is shameful from a young age and this continues to discourage conversations surrounding menstruation from occurring. In some of the most concerning cases and country contexts, many children do not know what a period is at the time of their first one. In India, this is the case for over half of the menstruation population (Sivakami et al., 2019). It is this silencing of the conversations around menstruation that has kept the issue of period poverty pervasive, yet highly ignored for so long. 

Period poverty is an issue that is not confined to countries that have high rates of poverty, but is experienced in even the wealthiest countries. In a study conducted on teens in the United States, one in every five girls struggled to afford period care products (Davies 2021). Additionally, in the United Kingdom, 50% of girls said that they were unable to afford menstrual products within the past year. An estimated 500 million women and girls do not have access to the tools that they need to adequately manage their periods (Pycroft 2022). This cost is only exacerbated by the amount that menstruation products are taxed. Pads and tampons are taxed between 4 and 7% in 22 states throughout the U.S. Taxes throughout the world can be seen as high as 20% (Rodriguez 2021). This makes menstrual products even more inaccessible to those struggling to find the money to pay for them.

Impact of Covid-19

Covid-19 has had the effect of exacerbating already persistent issues. This has been the case with period poverty. Particularly highlighted by the pandemic were the lack of access to sanitation facilities and clean water, a disruption in the access to menstrual products, and the loss of access to locations that provided education about menstruation aimed at addressing stigma and taboos.  This interruption showed the need for the inclusion of measures related to menstruation and hygiene in emergency response to global pandemics and other disasters across all sectors, including, but not limited to, health, education, and gender equity (The World Bank 2020).

Implications for Education and Participation in the Workforce

Not having the appropriate resources to deal with menstrual care has resulted in those who menstruate being absent from school. In Sub-Saharan Africa, one in every ten girls misses school at the time of their menstrual cycle. This can add up to missing as much as 20% of the school year (Lusk-Stover 2016). This statistic applies to the girls that stay in school after they begin their menstrual cycle, but many do not. In India, an estimated 23 million girls drop out of school annually due to a lack of proper facilities to safely manage their periods (Krishnan 2022). Most school bathrooms in India are not equipped with tampons and pads, and do not have the proper disposal bins for menstrual products. In some rural schools, facilities are located in a building separate from the school, or not provided. In such cases girls are faced with the risk of assault or rape when they have to make the trek to use the bathroom (Adukia 2016). This lack of accommodation for the needs of those who menstruate while at school, as well as the stigma and shame placed upon menstruating, has resulted in menstruating individuals missing or dropping out of school. We can see how this issue extends beyond the classroom and effects other aspects of freedom and mobility in the image below. Access to the proper products to handle menstruation makes a big difference. In Bangladesh, women miss an average of 6 days a month of work due to their menstrual cycle. When these women were provided the resources to manage their cycle, these numbers decreased (Mettler 2022). Providing those who menstruate with the facilities and resources to manage their menstrual cycle provides them with a more equitable chance to participate in education and the work force. 

Cycle of lack of access to period products, which leads to school absenteeism, to poor grades, to school dropout/ disinterest in school, to low level job, to low status of women in society, and circles back to lack of access to period products.
Image obtained from Michel et al., 2022

Global Response to Period Poverty

There have been efforts throughout the world by state governments, NGOs, and local grassroots organizations to mitigate the issue of period poverty. An aspect most widely recognized has been access to menstrual products. In the U.K., homeless shelters are able to request free condoms to distribute, but not free menstrual products. A campaign in 2015 called the Homeless Period asked the government to provide the same provisions to menstrual products as were being provided to condoms. The government has not been responsive to this request, but an organization called Bodyform vowed to donate 200,000 boxes of menstruation products by 2020. A similar fight was more successful in New York. There, they are now providing free tampons and pads in homeless shelters, as well as in in public schools and correctional facilities (Perez 2019).

However, most notably, Scotland was the first country in the world to provide free menstrual products to all of its menstruating citizens with a policy passed by the Scottish government in 2020. Menstrual products can be found at community and youth centers. Following suit, in 2021 France and New Zealand created policy that requires all schools to provide menstrual products to their students (Masterson 2022). Botswana, South Korea, and Zambia have also made notable efforts to provide free menstrual products for rural and school aged menstruating individuals, as well as in public places. 

Closely related to access to menstrual products are the taxes imposed upon those purchasing them. Kenya and South Africa have both made efforts to mitigate this extra imposition. Kenya became the first country to remove taxes on the importation of menstrual products in 2004, and South Africa has completely removed taxes on all menstrual products (Masterson 2022). In the U.S. today, there are still 22 states that charge taxes on menstrual products at between 4% and 7%. This number continues to diminish with states eliminating taxes on menstrual products each year. In 2022, Nebraska, Colorado, Iowa, and Virginia either significantly reduced their tax on period products or completely got rid of it (Alliance for Period Supplies 2022).

While cost seems to be the most recognized issue related to period poverty, there has been growing recognition surrounding the issues related to absences from school and days off of work to handle period management. In Spain, individuals who menstruate are allowed to take three to five days off of work each month for severe period pain. Similar efforts can be seen in Southeast Asia where in Japan menstruating individuals are offered a menstrual leave, and in Taiwan where individuals have three days of menstrual leave each year (Masterson 2022). However, the recognition of the pain that many individuals experience as a result of their menstrual cycle remains a peripheral issue, and the cases of Spain, Japan, and Taiwan continue to be outliers in the cause. 

Though it has been proven to be true that those who menstruate are not promised the resources to remain safe and healthy while menstruating, and additionally miss out on education and participation in the labor force because of it, little has been done on an international level to account for this inequity of safety, health, and opportunity. Two opportunities to address this, are in the sustainable development goals and in the Convention on the Elimination of all forms of Discrimination Against Women (CEDAW). CEDAW provides no reference to menstruation in its protections provided to women and girls and misses the opportunity to bring light to an issue faced by women worldwide (United Nations 2009). On the other hand, there are six Sustainable Development Goals (SDGs) that can be applied to the issue of period poverty: SDG 1; no poverty, SDG 3; good health and well-being, SDG 4: quality education, SDG 5; gender equality, SDG 6; clean water and sanitation, and SDG 10, reduced inequalities (Wilson 2022). Because of the large number of SGDs that could be applied to this issue, it is imperative that UN entities and governments take action towards such a widespread issue. Particularly, the Commission on the Status of Women (CSW) has the power to escalate the importance of the issue to the Economic and Social Council (ECOSOC) within the UN. 

Unfortunately, little has been done on a large scale because the issue is deeply intertwined with gender, and particularly women and girls. Issues related to women and girls often get ignored or under prioritized. Even so, framing this movement as one specific to women and girls neglects the non-binary, trans men, and other folks who are gender diverse that also experience menstruation (Wilson 2022). The movement has become hyper focused on the experience of women and girls in a way that neglects those who also menstruate that do not identify in that way, and misses the opportunity to provide those experiences in an analysis of the issue. Taking an approach that accounts for intersectionality, and examines the ways in which different aspects of identity interact to create various lived experiences, would provide a more comprehensive and inclusive exemplification of the issue and allow for more inclusive solutions (Symington 2004).  

Bar chart that shows the global and regional coverage of sanitation in schools, 2019.
Graphic obtained from Masterson 2022.

Policy Recommendations

The biggest issues surrounding period poverty can be tied to access and affordability, stigmatization, safety and sanitation, and gender inequality. The policy recommendations listed below take into account these prominent issues and how CSW might begin to create change around the attitudes towards menstruation and make recommendations to ECOSOC in order to provide those who menstruate with a more equitable opportunity to accessing their freedoms and rights. 

  1. The CSW should make a recommendation to ECOSOC to allocate an annual budget aimed at providing those who menstruate with the products necessary to safely manage their menstrual cycle. This budget could also be used to support organizations and programs already in place that work to provide individuals with free menstrual care products. In some cases, the latter may be necessary so as not to reinscribe colonial structures within developing countries (Hooks 2000). This budget would go to pads, tampons, and other period care products, and would be available at health facilities, schools, and community centers. As we have seen, a large barrier to those who menstruate attending school and participating in the workforce is linked to not having, and being able to afford, the proper tools to take care of their menstrual cycles. By providing these tools free of cost to those who menstruate, they are offered a more equitable chance at receiving an education and choosing to participate in the workforce.
  2. Another recommendation to ECOSOC should be programming aimed at providing access to facilities and clean water needed to safely manage menstrual care. While ECOSOC prioritizes the achievement of the SDGs, such as access to clean water and sanitation (SDG 6), a targeted approach must be taken to account for the lack of access to safe facilities that those who menstruate experience. All who menstruate must be provided with access to basic sanitation and access to a safe toilet. In a survey conducted by the World Health Organization and UNICEF in 2019, globally 63% of schools provide basic sanitation services (as can be seen in the graph provided above) (Masterson 2022). This is not enough. Those who menstruate are missing school and work because of this lack of access. Providing all with this access allows those who menstruate to access the tools needed to safely manage their period. 
  3. A third recommendation to ECOSOC would be the integration of health and sexual education programs within the curriculum of public schools for all children regardless of gender. This recommendation supports SDG 4, quality education, and SDG 5, gender equality. These programs would focus on the menstrual cycle as well as menstrual hygiene management. A well implemented education program would combat many issues that stem from taboos, fear, and shame surrounding the menstrual cycle. Working with children to address this issue and introduce these norms at a young age will begin to normalize menstruation and can create long term societal change (Elgström 2000). 
  4. The final recommendation is concerned with the way in which the movement is framed, and how it can be modified to be more inclusive. As mentioned previously, the movement aimed at providing justice and equity to those who menstruate has been largely a binary effort up until this point. Those who do not identify as women also menstruate. This would include trans men and nonbinary individuals. This binary framing of menstruation is harmful because it neglects to include others who are just as affected by period poverty, if not more, due to compounding aspects of their identities (Wade and Ferree 2015). The CSW should advocate for a change in language associated with menstruation such as using ‘individuals who menstruate’ instead of ‘women and girls’, as well as collect data that is reflective of the whole of the population that menstruates. This will create a more inclusive and progressive movement. 

Conclusion

Period poverty is an injustice to those who menstruate everywhere. Even in the most developed countries, we continue to see large parts of the population unable to afford or access the products that they need to take care of themselves while menstruating. Period poverty prevents those who menstruate from receiving an education and from participating in the workforce, and menstruating individuals continue to be ridiculed and excluded for something human and natural across the globe. There have been efforts to provide access and products for those who menstruate in different country contexts, but what must happen, and what the Convention on the Status of Women must advocate for, is wholistic approach that accounts for the stigmatization of menstruation that made period poverty a reality. 

Resources

Adukia, A. (2016). Sanitation and Education. University of Chicago. 10.1257/app.20150083 

https://www.jstor.org/stable/26156194

Alliance for Period Supplies (2022). Tampon Tax. Alliance for Period Supplies. https://allianceforperiodsupplies.org/tampon-tax/?gclid=CjwKCAiA-dCcBhBQEiwAeWidtV–H3Idiqft85T1hg2MQm1ZDzILwtxnYynUKBsZsODjD8VhVFmwthoC8HwQAvD_BwE

Davies, S., Clarke, G., and Lewis, N. (2021). Period Poverty: The Public Health Crisis We Don’t Talk About. Children’s Hospital of Philadelphia PolicyLab. https://policylab.chop.edu/blog/period-poverty-public-health-crisis-we-dont-talk-about

Elgström, O. (2000). Norm negotiations. The construction of new norms regarding gender and development in EU foreign aid policy, Journal of European Public Policy, 7:3, 457-476, DOI: 10.1080/13501760050086125 

Hooks, B. (2000). Feminism is for everybody. South End Press. 

Krishnan, M. (2022). India: Menstruation taboos are Forcing girls out of school. Deutsche Welle. https://www.dw.com/en/india-menstruation-taboos/a-63341007

Masterson, V. (2022). The unsanitary truth about period poverty- and what governments can do. World Economic Forum. https://www.weforum.org/agenda/2022/06/period-poverty-pain-stigma/

Michel, J., Mettler, A., Schönenberger, S., and Gunz, D. (2022). Period poverty: why it should be everybody’s business. Journal of Global Health Reports. 2022;6:e2022009. doi:10.29392/001c.32436

Perez, C. C. (2019). Invisible Women; Data Bias in a World Designed for Men. Abrams Press. 

Pycroft, H. (2022). Period poverty: the statistics around the world. ActionAid. https://www.actionaid.org.uk/blog/2022/05/18/period-poverty-statistics-around-world

Rodriguez, L. (2021). The Tampon Tax: Everything You Need to Know. Global Citizen. https://www.globalcitizen.org/en/content/tampon-tax-explained-definition-facts-statistics/

Sivakami, M., Maria van Eijk, A., Thakur, H., Kakade, N., Patil, C., Shinde, S., Surani, N., Bauman, A., Zulaika, G., Kabir, Y., Dobhal, A., Singh, P., Tahiliani, B., Mason, L., Alexander, K. T., Thakkar, M. B., Laserson, K. F., & Phillips-Howard, P. A. (2019). Effect of menstruation on girls and their schooling, and facilitators of menstrual hygiene management in schools: surveys in government schools in three states in India, 2015. Journal of global health9(1), 010408. https://doi.org/10.7189/jogh.09.010408

Symington, A. (2004). Intersectionality: A Tool for Gender and Economic Justice. The Association for Women’s Rights in Development. Women’s Rights and Economic Change, No.9.

United Nations Women (2019). Infographic: End the stigma. Period. United Nations Women. https://www.unwomen.org/en/digital-library/multimedia/2019/10/infographic-periods

United Nations (2009). Convention on the Elimination of All forms of Discrimination against Women. United Nations Entity for Gender Equality and the Empowerment of Women. https://www.un.org/womenwatch/daw/cedaw/text/econvention.htm#article1

Wade, L. and Ferree, M. M. (2015). Gender; Ideas, Interactions, Institutions. W. W. Norton and Company Inc. 

Waste Management World. (2021). Women in Waste Management; Global survey on women in waste management. Waste Management World.https://waste-management-world.com/research-news/global-survey-on-women-in-waste-management/

Wilson, R. (2022). The Cost of a Period: The SDGs and Period Poverty. International Institute for Sustainable Development. https://sdg.iisd.org/commentary/generation-2030/the-cost-of-a-period-the-sdgs-and-period-poverty/

The World Bank (2020). Periods Don’t Stop for Pandemics- Neither Will Our Efforts to Bring Safe Menstrual Hygiene to Women and Girls. The World Bank. https://www.worldbank.org/en/news/feature/2020/05/28/menstrual-hygiene-day-2020