Over-the-counter access to combined oral contraceptives for individuals with hypertension: an expert review

Abstract

Efforts are underway to move a combined oral contraceptive over the counter in the United States. However, hypertension is an important contraindication and questions exist regarding how users should screen for it in an over-the-counter setting. An expert panel convened in April 2022 to review the literature related to hypertension and an over-the-counter switch for combined oral contraceptives and vote on a set of blood pressure screening recommendations for future over-the-counter combined oral contraceptives. Research indicates that people can accurately self-screen for contraindications to combined oral contraceptives using simple checklists, and the absolute risk of adverse events is low among people with hypertension who use combined oral contraceptives and must be balanced against substantially higher risks of pregnancy as well as benefits of increased contraceptive access. Based on these data, the panel concluded that 1) individuals who have not had their blood pressure checked in the last year or do not know their blood pressure should be advised in product labeling to get it checked prior to purchase; 2) blood pressure documentation should not be required to purchase over-the-counter combined oral contraceptives, provided over-the-counter switch behavioral studies demonstrate individuals can correctly self-screen for use; and 3) blood pressure screening should be made more accessible and affordable. Over-the-counter combined oral contraceptives may increase access to the most commonly used reversible contraceptive method. They may also provide an opportunity for enhanced education and awareness of hypertension and preventive cardiovascular screenings among people of reproductive age, particularly young people and people of color.

1. Introduction

Barriers related to the prescription status of oral contraceptives, such as challenges making an appointment, long wait times, inconvenient clinic hours, and having to take time off from work or school, can make it difficult for people to access contraception [1]. Due to systemic inequities, these barriers are often exacerbated for Native American/Indigenous communities and people of color [[2], [3], [4], [5]]. Adolescents and young people may face additional and specific barriers to accessing contraception such as lack of confidentiality, parental involvement laws, financial barriers, and fear of judgment from providers [[6], [7], [8]]. See Table 1 for stories on this lived experience.

Table 1.

Stories on the lived experience of barriers to prescription contraception.

A sample of public comments submitted to the Food and Drug Administration for the May 9–10, 2023 Joint Meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee Meeting [59], for an application to make a norgestrel 0.075mg oral contraceptive pill (Opill) available over the counter:

Insurance

•“I had graduated from a master’s program and was unemployed. I had no health insurance and couldn’t afford my birth control. I have been on the pill for over a decade and not having the certainty of being able to continue this standard of care was truly scary. I don’t want anybody to have to deal with this fear or not being able to afford access to a basic human right.”

Confidentiality and autonomy

•“As a 14-year-old, I found it difficult to obtain birth control through the prescription-only system due to controlling parents and other barriers. The ability to access birth control without a prescription would have made a significant difference in my life, allowing me to take control of my reproductive health without judgment or disapproval.”

Systemic barriers

•“When I started college…I went to my university’s student health center to request a prescription for birth control pills. However, I was told that since my university is Catholic, I could only be prescribed birth control pills for non-contraceptive purposes .… it took me three months to navigate finding a new doctor in a new city and getting an appointment before I could finally pick up the birth control pills that I needed.”

•“After experiencing homelessness in high school and moving in with my partner, birth control helped me take control of my body and my future …. But let’s be clear, accessing this essential care was difficult without money, parents, or insurance.”

•“The ability to make autonomous decisions about reproductive health has never been guaranteed for Black women, girls, and gender expansive people. Contraception has long been used as a tool of oppression. This history has led to a mistrust in health care institutions, which can make it more difficult for Black women to access contraception …. An over-the-counter option will put control back in the hands of Black women, girls, and gender expansive people, while also providing them with safe and effective contraception.”

Logistical barriers

•“I was 12 when I first needed birth control to help treat my abnormally painful menstruation. It was difficult for my single mother to take time out of her workday to schedule a doctor's appointment for my care, and I couldn't very well go on my own.”

•“With the prescription-only system, I often had to skip class to get an appointment. Appointments were hard to come by, and resulted in extra costs. There were times that my birth control use was inconsistent due to not having the time for an appointment. This had resulted in me having to use emergency contraception multiple times, which really messed with my hormones. Not to mention the immense cost of emergency contraception, which imposed additional financial difficulties.”

•“I started on the pill first because I had a heavy period which made it hard to go to school and lead life …. I was on the pill for five years and it changed my life. Finally, my period didn't mean debilitating pain …. While this was amazing, it was frustrating that I had to be so careful about tracking when my prescription was getting close to empty and that I packed it when I went on vacation. I was especially careful because missing days meant my whole system was thrown out of wack [sic]. I wished that it could be over the counter since it was so vital to my life.”

In July 2023, the US Food and Drug Administration (FDA) approved the first over-the-counter daily oral contraceptive, a progestin-only pill containing norgestrel 0.075 mg called Opill [9]. Building on this approval, an over-the-counter combined oral contraceptive could further expand access to contraception. However, hypertension is an important contraindication to combined oral contraceptives [10] that may present a more complex pathway to over-the-counter approval.

At least one company, Cadence Health (now Cadence OTC), is pursuing an over-the-counter switch for a combined oral contraceptive [9]. However, it was reported that in 2021 the FDA placed a hold on its actual use trial, a clinical study being conducted for its over-the-counter application, telling the company that additional assessment of blood pressure for trial participants was needed [11,12]. The FDA has since issued new guidance on the use of technology for over-the-counter products. A 2024 rule from the FDA established a new category of “over-the-counter” drugs with an Additional Condition for Nonprescription Use (ACNU) that allows novel tools for screening or directions for use, such as mobile apps, in-store kiosks, or automated telephone systems [13]. According to media reports, Cadence OTC is developing an “easy-to-use technology interface” for its over-the-counter product [12] to address the FDA’s blood pressure concerns, and is planning to use the ACNU rule for its combined oral contraceptive pill [14].

Considering questions that clinicians, policymakers, advocates, and pharmaceutical companies may have regarding how users should screen for hypertension for over-the-counter combined oral contraceptives, we aimed to comprehensively review the data on this topic and develop evidence-based expert recommendations on blood pressure screening for future over-the-counter combined oral contraceptives.

2. Methods

2.1. Literature review

To inform the development of a set of recommendations related to blood pressure screening for future over-the-counter combined oral contraceptives, we conducted a review of the literature on the following topics: 1) current clinical guidelines for hypertension screening when prescribing combined oral contraceptives, 2) self-screening for combined oral contraceptives, 3) the prevalence of hypertension and other contraindications to combined oral contraceptives, 4) hypertension-related risks of combined oral contraceptives and pregnancy, 5) benefits of over-the-counter access to combined oral contraceptives, and 6) other over-the-counter products with blood pressure warnings.

2.2. Expert panel

A diverse group of 19 experts, comprised of clinicians (including specialists in adolescent medicine, complex family planning, general internal medicine, obstetrics and gynecology, and pediatrics), regulatory specialists with expertise in over-the-counter switch applications with the FDA, reproductive justice advocates, and researchers convened in a series of virtual meetings in April 2022. These meetings included presentations on the above data from individuals with expertise in adolescent medicine, cardiology, general internal medicine, obstetrics and gynecology, prescription-to-over-the-counter switch regulation, and reproductive justice, followed by meeting discussions. During meeting registration as well as at the beginning of each meeting, participants were asked to disclose any potential conflicts of interest. One participant was employed by a non-profit pharmaceutical company, and another participant consulted with a client working on an over-the-counter oral contraceptive.

Following meeting presentations and discussion, a facilitator presented three questions related to blood pressure screening for future over-the-counter combined oral contraceptives, and the panel voted using an online poll. When participants did not agree, the facilitator guided discussion and expert recommendation revisions until they reflected the group’s perspectives.

3. Results

3.1. Current clinical practice: hypertension screening when prescribing combined oral contraceptives

The American College of Obstetricians and Gynecologists practice guidelines, based on the Centers for Disease Control and Prevention’s US Medical Eligibility Criteria for Contraceptive Use, state that individuals with blood pressure ≥140/90 mm Hg should not use combined hormonal contraceptives unless no other method is acceptable or appropriate (Medical Eligibility Criteria category 3 classification, a condition for which the theoretical or proven risks usually outweigh the advantages of using the method), and those with blood pressure ≥160/100 mm Hg should not use combined hormonal contraception (Medical Eligibility Criteria category 4 classification, a condition that represents an unacceptable health risk if the contraceptive method is used) [10,15]. Use of combined hormonal contraception among individuals with adequately controlled hypertension is Medical Eligibility Criteria category 3, and the practice guidelines state clinicians should use their judgement regarding risk of pregnancy and patient attitudes toward alternatives [10,15].

The Centers for Disease Control and Prevention’s US Selected Practice Recommendations for Contraceptive Use, a set of recommendations for healthcare providers regarding initiation and use of contraceptive methods, state that blood pressure should be measured before initiation of combined oral contraceptives, and that no routine follow-up visit is required. However, at other routine visits, clinicians should assess blood pressure and any changes in health status [16]. For healthy individuals ≤35 years with well-controlled hypertension who initiate a combined hormonal contraceptive, an algorithm based on expert opinion recommends continued blood pressure monitoring 2–4 weeks after starting the method and at follow-up visits every 6 months; if blood pressure increases in the absence of other causes, the combined hormonal contraceptive should be discontinued [17].

Despite the recommendations for clinician blood pressure screening before prescribing combined oral contraceptives, this does not result in perfect elimination of hypertension risk, as highlighted by research showing blood pressure assessment may be suboptimal in clinical practice [18]. Additionally, studies suggest 1.6 %−5.6 % of combined oral contraceptive users have hypertension ≥140/90 mm Hg [19,20].

While hypertension diagnoses are usually made in a clinical setting, screening alternatives include pharmacists’ screening, self-screening machines at pharmacies and other public locations, and at-home blood pressure monitors. In some contexts (like pregnancy), insurance may cover the cost of an at-home monitor. Appropriate cuff size is critical for accurate blood pressure measurement. However, some publicly available monitors offer only one size, which can underestimate or overestimate actual blood pressure [21].

3.2. Self-screening for contraindications to combined oral contraceptives

Studies indicate that most people can accurately self-screen for contraindications to combined oral contraceptives using simple checklists. In one study, 7 % of participants incorrectly thought they were eligible for a combined oral contraceptive when they actually had a contraindication, primarily undiagnosed hypertension [22]. Another study found overall participant-provider agreement of 96 % across key medical eligibility criteria for combined hormonal contraceptives, including >99 % for hypertension [23]. In a study of adolescent and young adults’ ability to self-report potential contraindications to hormonal contraception compared with physician reports (with an oversampling of participants with chronic illnesses and known medical contraindications), 4 % reported they did not have hypertension when in fact they did. When young women were discordant with physician reports of contraindications, they mostly over-reported contraindications [24].

In a pilot label comprehension study to evaluate consumer understanding of key messages for use for an over-the-counter combined oral contraceptive, participants overwhelmingly understood the drug facts label information [25]. Ten of the 11 primary messages and 10 of the 11 secondary messages were each understood by ≥95 % of participants; 99 % of participants understood the label messages related to high blood pressure, which included “Ask a doctor or other healthcare provider before starting use if you have high blood pressure or don’t know your blood pressure” and “Continue use but talk to a doctor or other healthcare provider if you develop high blood pressure” [25].

3.3. Prevalence of hypertension and other contraindications to combined oral contraceptives

In 2017, the American College of Cardiology and American Heart Association released new hypertension guidelines defining hypertension as ≥130/80 mm Hg compared to the prior definition of ≥140/90 mm Hg [26]. This change resulted in a substantial increase in the number of adults diagnosed with hypertension [17]. Under the 2017 guidelines, an estimated 19 % of US women of reproductive age have hypertension compared to 9 % who were estimated to have hypertension under the previous guidelines [27]. Hypertension is rare among US adolescent females, with 1.2 % aged 13–17 years estimated to have hypertension ≥130/80 mm Hg [28]. Among people of all ages in the United States, including women of reproductive age, hypertension prevalence is highest among Black individuals compared to those of other racial and ethnic identities [27,29,30]. Thirty-one percent of non-Hispanic Black women aged 20–44 years are estimated to have blood pressure ≥130/80 mm Hg, and 18 % to have Stage 2 hypertension ≥140/90 mm Hg [27]. Approximately 17 % of women of reproductive age with blood pressure ≥140/90 mm Hg are unaware of their hypertension diagnosis [31]; under the current hypertension definition of ≥130/80 mm Hg, this proportion is likely larger. As of December 2024, the Centers for Disease Control and Prevention have not lowered the blood pressure thresholds for the category 3 and 4 contraindications to combined hormonal contraception in the US Medical Eligibility Criteria for Contraceptive Use [10].

In one study of women from the general population aged 18–49 years in El Paso, Texas, 39 % of participants had at least one relative or absolute contraindication to combined oral contraceptives, mainly hypertension ≥140/90 mm Hg (14.5 %) and migraine with aura (17.6 %) [22]. However, other research suggests that contraindications are rarer among people seeking contraception, with one study finding only 2 % of women aged 14–45 years seeking a combined hormonal contraceptive had a contraindication, including 1.7 % with hypertension ≥140/90 mm Hg [32]. A study of 248 oral contraceptive users aged 20–51 years found that 1.6 % (95 % confidence interval 0.6–4.3 %) had hypertension ≥140/90 mm Hg [20]. A cohort study of women aged 18–44 years living in El Paso, Texas who used combined oral contraceptives found 5.6 % of those getting them from clinics and 9.8 % getting them over the counter in Mexico had hypertension ≥140/90 mm Hg [19].

3.4. Hypertension-related risks of combined oral contraceptives

Older generation formulations of combined oral contraceptives are associated with an increase in systolic blood pressure of up to 7–8 mm Hg; however, smaller changes in blood pressure are associated with newer and lower dose 20 mg ethinyl estradiol combined oral contraceptives, and drospironone in some combined oral contraceptives lowers blood pressure [17,33]. A systematic review with a limited body of evidence did not suggest an increased risk of hypertension after starting combined oral contraception [34], and the American College of Obstetricians and Gynecologists categorizes blood pressure increases associated with combined oral contraceptive use as unlikely to be clinically significant [15]. In general, cardiovascular disease risk increases with increasing blood pressure—beginning at 115/75 mm Hg, this risk doubles with each increase of 20/10 mm Hg [35].

People with hypertension who use combined oral contraceptives are at higher risk for cardiovascular events, including stroke and acute myocardial infarction, compared to hypertensive non-users of oral contraceptives; they are not at higher risk for venous thromboembolism [35]. Other conditions, such as smoking and diabetes, exacerbate the cardiovascular risks associated with hypertension [10]. Three studies in a systematic review reported 1.2–1.6 greater odds of acute myocardial infarction among women with hypertension who used combined oral contraceptive compared to non-users, while another found approximately 12 times greater risk [35]. Most studies found a similar increase in the risk of stroke among hypertensive combined oral contraceptive users compared to hypertensive non-users (odds ratios of 1.5–2) [35].

While these studies show increased risk of cardiovascular events among individuals with hypertension who use combined oral contraceptives compared to non-users, the absolute risk of these events among women of reproductive age is low [35], and a doubling of a rare event remains rare. In a review of the literature, we did not identify research reporting on rates of cardiovascular events among individuals with hypertension who use combined oral contraceptives compared to non-users. However, one study used modeling to estimate that the rate of cardiovascular events among women aged 20–24 years is 312 per million woman-years among women with hypertension using low-dose combined oral contraceptives compared to 134 per million among non-users with hypertension, and increases to 1213 and 529 events per million woman-years, respectively, at ages 40–44 years [35,36].

3.5. Hypertension-related risks of pregnancy

Morbidity and mortality risks of combined oral contraceptive use among hypertensive individuals must be balanced against those of having an unintended pregnancy with hypertension, which are substantially higher [37]. Hypertensive disorders are the most prevalent cardiovascular condition during pregnancy, occurring in approximately 16 % of pregnancies in the United States [38], and are associated with increased long-term cardiovascular risk [39]. Among these, preeclampsia occurs in approximately 4 % of pregnancies and can be life threatening [40]. Black individuals are more likely to experience hypertensive disorders and preeclampsia during pregnancy than those of other racial and ethnic identities in the United States [39,40], while Asian and Pacific Islander people with preeclampsia are at the highest risk of developing acute cardiovascular complications during delivery [39].

3.6. Benefits of over-the-counter access to combined oral contraceptives

Studies show that an over-the-counter switch for oral contraceptives may lead to higher rates of initiation [41,42] and continuation [43], and that people are interested in using them [41,42,44]. Leading medical associations including the American College of Obstetricians and Gynecologists, the American Academy of Family Physicians, and the American Medical Association support over-the-counter access to oral contraceptives [[45], [46], [47]]. In fact, the American College of Obstetricians and Gynecologists supports over-the-counter access to all hormonal contraceptives, noting that an adequate self-screening tool, such as a checklist, is important for combined hormonal methods [45].

Combined oral contraceptives are among the most widely used medications and have a well-established safety profile [48]. Benefits compared to progestin-only pills, which are already over the counter, include their popularity and likelihood that they are a formulation that people already know and use, with an estimated 94–96 % of oral contraceptive users in the United States in 1996–2010 using combined oral contraceptives [49,50]. Combined oral contraceptives also have greater flexibility, without a label guideline to take each pill within 27 h of the previous one, as most progestin-only pills registered in the United States have [51]. Combined oral contraceptive users also tend to have more regular bleeding patterns while taking the product and less breakthrough bleeding compared to progestin-only pill users [52,53]. Additional non-contraceptive benefits include acne reduction and reduced risk of several cancers [52]. However, compared to progestin-only pills, combined oral contraceptives have a greater number and prevalence of contraindications [10,19,54], some of which are more prevalent in certain populations, such as hypertension among Black women [55].

3.7. Other over-the-counter products with blood pressure warnings

A number of over-the-counter drugs have blood pressure warnings on their drug facts label. These include non-steroidal anti-inflammatory drugs, decongestants, asthma products, and drugs with high levels of sodium, which contain the instruction to "Ask a doctor before use if you have high blood pressure." No drugs with blood pressure warnings on their drug facts label require users to test their blood pressure before purchasing or using the product. We did not identify any published self-selection studies for these medications in which accuracy of hypertension self-diagnosis was assessed.

3.8. Recommendations

Following a review of the above literature and group discussion, participants came to consensus on three questions.

Question 1: Is it necessary to document an actual blood pressure measurement (via a mobile app, website, or other modality) prior to purchase of an over-the-counter combined oral contraceptive?

• Recommendation: It is not necessary to document an actual blood pressure for purchase of the product, provided that over-the-counter switch behavioral studies, such as self-selection and actual use trials, demonstrate that individuals can correctly self-screen for product use.

Question 2: Who, if anyone, should be advised (but not necessarily required) to check their blood pressure prior to purchase of an over-the-counter combined oral contraceptive?

• Recommendation: Individuals who do not know their blood pressure or who have not had their blood pressure checked within the last year should be advised in product labeling to check it prior to purchase. Additionally, information on multiple risk factors for high blood pressure and cardiovascular disease (such as smoking and diabetes) should be included in supplemental pamphlets or product inserts.

Question 3: How could screening for hypertension be expanded to meet the needs of individuals purchasing an over-the-counter combined oral contraceptive?

• Recommendation: Home blood pressure monitors should be made more affordable and covered by insurance, and pharmacies and other locations with public access to blood pressure monitors should provide a wide range of cuff sizes to improve accuracy of measurements. Additional research is needed to identify non-traditional venues and new approaches to increase access to blood pressure monitoring, including smartphone applications and wearable devices.

4. Discussion

We engaged a diverse group of experts to review the evidence on hypertension and combined oral contraceptives and reach consensus on blood pressure screening recommendations for future over-the-counter combined oral contraceptives. The panel supported over-the-counter access to combined oral contraceptives without requiring users to document their blood pressure before purchasing or using the product, provided that over-the-counter switch behavioral studies demonstrate that individuals can correctly self-screen for use. The panel recommended that individuals who do not know their blood pressure or have not had their blood pressure checked in the last year should be advised in product labeling to get it checked prior to purchase, and that blood pressure screening should be made more accessible and affordable. Additionally, the panel recommended additional consumer education on multiple risk factors for high blood pressure, which can increase the risk of cardiovascular disease.

In deliberating on these questions, experts weighed the risks and benefits of over-the-counter access for combined oral contraceptives, as well as those of mandating blood pressure screening documentation. Prior research indicates that people generally can accurately self-screen for contraindications to combined oral contraceptives using simple checklists [22,23], and the absolute risk of adverse events is low among people with hypertension who use combined oral contraceptives [35], and must be balanced against the substantially higher risks of pregnancy [37] as well as benefits of increased contraceptive access. Further, research demonstrates that users may be more conservative than physicians in self-screening [24].

Requiring users to document blood pressure would impose new barriers related to users’ technology access, restrict how the product could be accessed (for example, precluding vending machines and other locations where documentation could not be confirmed), increase costs, and add hurdles that could impact timely access and disproportionately affect those already facing the greatest barriers to contraception. Such a requirement would be a departure from how all other over-the-counter drugs contraindicated for those with high blood pressure are accessed.

Overall, the panel agreed that over-the-counter access for combined oral contraceptives presents a valuable opportunity to educate people of all ages, including adolescents, on how to enhance awareness and manage their own health when thinking about the intersections and risks of hypertension, contraception, and pregnancy. Given that nearly one-in-five women of reproductive age with high blood pressure is unaware of their hypertension status [37], it seems evident that there are barriers to screening, diagnosis, and management of hypertension. Racial and ethnic disparities exist in the levels of awareness, treatment, and control of hypertension [29], and lack of health insurance, cost, and limited access to health care services as well as other structural inequalities and systemic racism contribute to these disparities [29,56,57]. Additionally, for Native American/Indigenous people living on reservation or tribal land and individuals living in rural areas, access to clinics for blood pressure screening and contraception can be challenging due to long travel times and limited clinic hours [3]. Limited access to grocery stores and pharmacies can also make it challenging for people living in rural areas to access blood pressure screening in these public spaces [3]. It is critical to increase access to blood pressure screening when considering an over-the-counter combined oral contraceptive; that people have adequate information and education on how to measure blood pressure properly and accurately at home; and that public screening sites have a wide range of cuff sizes. Expanded methods and settings should be explored for hypertension screening access, including at non-primary care visits, schools, places of work and worship, and community events.

An over-the-counter progestin-only pill is now available in the United States and an over-the-counter combined oral contraceptive would add another popular contraceptive option. Removing the prescription for a combined oral contraceptive could help to reduce barriers to its access including obstacles related to being underinsured and uninsured, privacy concerns, and accessing a clinic. It is imperative, however, to ensure over-the-counter methods are affordably priced and equitably available to all communities, including rural communities, young people, those without insurance, Native American/Indigenous communities relying on the Indian Health Service, and those with other forms of public insurance. This would further increase reproductive autonomy and choice, promote the long-standing self-care movement [58], and help address stigma surrounding contraception.

4.1. Limitations

The recommendations from this convening of experts represent a diverse group of clinical, research, regulatory, and reproductive justice stakeholders. However, a limitation to the panel was that it did not include potential users, who could have provided additional insights into the questions posed to the panel. Future research should explore potential users’ lived experiences on how hypertension screening could be expanded to meet their needs. Further, additional stakeholders including those at the FDA will ultimately decide on these questions as part of their review of an application to make a specific combined oral contraceptive product available over the counter in the United States.

5. Conclusions

Over-the-counter combined oral contraceptives provide an opportunity to increase access to the most used reversible contraceptive method, as well as education and awareness of hypertension and preventive cardiovascular screenings among people of reproductive age, particularly young people and people of color.

Author agreement

All authors have seen and approved the final version of the manuscript being submitted. They warrant that the article is the authors' original work, hasn't received prior publication and isn't under consideration for publication elsewhere.

Funding

This work was made possible with generous support from the Collaborative for Gender + Reproductive Equity and the David and Lucile Packard Foundation. Additionally, MG was supported by contracts from the National Heart, Lung, and Blood Institutes nos. N01-HV-068161, N01-HV-068162, N01-HV-068163, N01-HV-068164, grants U01 HL064829, U01 HL649141, U01 HL649241, K23 HL105787, K23 HL125941, K23 HL127262, K23HL151867, T32 HL069751, R01 HL090957, R03 AG032631, R01 HL146158, R01 HL146158–04S1, R01 HL124649, R01 HL153500, U54 AG065141, General Clinical Research Center grant MO1-RR00425 from the National Center for Research Resources, the National Center for Advancing Translational Sciences Grant UL1TR000124, Department of Defense grant PR161603 (CDMRP-DoD), and grants from the Gustavus and Louis Pfeiffer Research Foundation, Danville, NJ, The Women’s Guild of Cedars-Sinai Medical Center, Los Angeles, CA, The Ladies Hospital Aid Society of Western Pennsylvania, Pittsburgh, PA, QMED, Inc., Laurence Harbor, NJ, the Edythe L. Broad and the Constance Austin Women’s Heart Research Fellowships, Cedars-Sinai Medical Center, Los Angeles, CA, the Barbra Streisand Women’s Cardiovascular Research and Education Program, Cedars-Sinai Medical Center, Los Angeles, CA, The Society for Women’s Health Research, Washington, D.C., the Linda Joy Pollin Women’s Heart Health Program, the Erika Glazer Women’s Heart Health Project, the Adelson Family Foundation, Cedars-Sinai Medical Center, Los Angeles, CA, Robert A. Winn Diversity in Clinical Trials Career Development Award (Winn CDA), and the Anita Dann Friedman Endowment in Women’s Cardiovascular Medicine & Research. This work is solely the responsibility of the authors and does not necessarily represent the official views of the National Heart, Lung, and Blood Institute, the National Institutes of Health, or the U.S. Department of Health and Human Services. The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Ethical review: This state-of-the-art review study did not involve human subjects and was not subject to ethical review.

Conflict of Interest Disclosures: The authors report no conflict of interest. KG and KK are affiliated with Ibis Reproductive Health, which has a partnership with HRA Pharma in which Ibis provided financial support for some of the research that was part of an over-the-counter switch application to the US FDA for a progestin-only pill. Ibis receives no monetary compensation nor ownership of any rights to the product. Ibis raised the funding for this partnership from a private foundation and selected HRA Pharma as its partner through an open process overseen by the Oral Contraceptives Over-the-Counter Working Group steering committee in an effort to incentivize a pharmaceutical company to complete the work to make a birth control pill available over the counter. DG reported receiving grants from Ibis Reproductive Health outside the submitted work and being a member of the Free the Pill Coalition steering committee. MG reported consulting with Novartis, Esperion, and Medtronic Inc, and serves on a DSMB for an investigational product for Merck, all unrelated to this topic. MK reported consulting with HRA Pharma on its over-the-counter switch application to the US FDA for a progestin-only pill.

CRediT authorship contribution statement

Kate Grindlay: Writing – review & editing, Writing – original draft, Formal analysis, Data curation, Conceptualization. Katherine Key: Writing – review & editing, Writing – original draft, Formal analysis, Data curation. Raegan McDonald-Mosley: Writing – review & editing, Formal analysis, Data curation. Melissa Kottke: Writing – review & editing, Formal analysis, Data curation. Dázon Dixon Diallo: Writing – review & editing, Formal analysis, Data curation. Martha Gulati: Writing – review & editing, Formal analysis, Data curation. Daniel Grossman: Writing – review & editing, Formal analysis, Data curation, Conceptualization.

Declaration of competing interest

The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Kate Grindlay and Katherine Key reports financial support was provided by Collaborative for Gender + Reproductive Equity. Kate Grindlay and Katherine Key reports financial support was provided by David and Lucile Packard Foundation. Martha Gulati reports financial support was provided by National Heart Lung and Blood Institute. Martha Gulati reports financial support was provided by National Center for Research Resources. Martha Gulati reports financial support was provided by National Center for Advancing Translational Sciences. Martha Gulati reports financial support was provided by Department of Defense. Martha Gulati reports financial support was provided by Gustavus and Louis Pfeiffer Research Foundation. Martha Gulati reports financial support was provided by Women’s Guild of Cedars Sinai Medical Center. Martha Gulati reports financial support was provided by The Ladies Hospital Aid Society of Western Pennsylvania. Martha Gulati reports financial support was provided by Cedars-Sinai Medical Center. Martha Gulati reports financial support was provided by Society for Women’s Health Research. Martha Gulati reports financial support was provided by Adelson Family Foundation. Martha Gulati reports financial support was provided by Robert A. Winn Diversity in Clinical Trials Career Development Award. Martha Gulati reports financial support was provided by Anita Dann Friedman Endowment in Women’s Cardiovascular Medicine and Research. KG and KK are affiliated with Ibis Reproductive Health, which has a partnership with HRA Pharma in which Ibis provided financial support for some of the research that was part of an over-the-counter switch application to the US FDA for a progestin-only pill. Ibis receives no monetary compensation nor ownership of any rights to the product. Ibis raised the funding for this partnership from a private foundation and selected HRA Pharma as its partner through an open process overseen by the Oral Contraceptives Over-the-Counter Working Group steering committee in an effort to incentivize a pharmaceutical company to complete the work to make a birth control pill available over the counter. DG reported receiving grants from Ibis Reproductive Health outside the submitted work and being a member of the Free the Pill Coalition steering committee. MG reported consulting with Novartis, Esperion, and Medtronic Inc, and serves on a DSMB for an investigational product for Merck, all unrelated to this topic. MK reported consulting with HRA Pharma on its over-the-counter switch application to the US FDA for a progestin-only pill. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.