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My mother may have had more formal rights than the generations before her, but she still faced systems that were not built around women’s needs. Contraception is one example: greater legal access did not mean easy access in the 70s and 80s. Affordability, availability, and stigma still shaped whether women could actually obtain reproductive care, and state barriers to contraception for unmarried women and adolescents remained present. She also lived through workplace and insurance barriers. The Pregnancy Discrimination Act did not arrive until 1978, a response to a system that forced many women to choose between work and family.
By the time I reached adolescence in the 90s, women had more rights on paper, but access still depended heavily on income, insurance, and employer policies. I grew up in an era when women had long been excluded from clinical trials, without fully realizing how profoundly this impacted scientific understanding. It took the NIH Revitalization Act of 1993 to begin changing that, and after decades of underinvestment in women’s health research, efforts such as the Women’s Health Initiative (WHI) began to shift the landscape.
Even as policy and research gained momentum, access remained uneven as I entered adulthood. By the mid-2000s, insurance gaps continued to burden women, with over 17 million uninsured in the United States (KFF). Barriers had become increasingly financial and structural: coverage was inconsistent for everything from contraception to maternity care, and access still depended heavily on income, employment, insurance type, and state policy. Around the same time, my mother entered menopause and encountered another kind of barrier: limited access to hormone therapy, shaped by the post-WHI climate of caution and reinforced by FDA labeling.
So, what has changed? Women’s access barriers are now less about whether care exists and more about whether women can reach it, afford it, trust it, and fit it into their lives. Structural factors such as coverage, provider availability, and the broader social determinants of health still shape whether women receive care. While the Affordable Care Act’s contraceptive coverage requirement helped to reduce out-of-pocket costs, contraception remains vulnerable to cost and coverage gaps. Mental health care is still difficult to access. Menopause care remains under-discussed and under-supported, impacted by the limited time devoted to the topic in medical school training and historical gaps in clinical research for women’s health. Discrimination and mistreatment persist: Black women continue to experience maternal mortality at numbers that dwarf what women of other racial and ethnic groups experience (NIH).
Women today do not face a single access problem. They face many, layered across every stage of life.
It’s clear that existing models of care are not meeting the needs of women. Even when a woman is fortunate enough to have access to a primary care physician, opportunity costs, systemic hurdles, and out-of-pocket expenses can still prevent her from getting the care she needs. And this is only going to get worse: research suggests a shortage of between 40,800 and 104,900 physicians by 2030 (AAMC).
Telehealth is helping. Since the pandemic, it has become mainstream, accounting for more than 5% of medical claim lines in 2025 (Fair Health). But its growth is stabilizing, demonstrating the limits of a model that still depends on scheduling, clinician availability, and cost. Telehealth improves access but does not fully solve the problem.
To significantly expand access to healthcare, we require new approaches. One promising approach is called ACNU, a four-letter acronym for “Additional Condition for Nonprescription Use,” which essentially spells out a new regulatory pathway for making a prescription medication also available as a nonprescription medication for "qualified” individuals. In practice, this could mean making contraception, menopause hormone therapy, migraine medications, statins, and perhaps hundreds of other drugs available to appropriate individuals without a doctor’s prescription.
The “additional condition” within ACNU is what differentiates this incremental pathway. An ACNU is not a prescription medication, but it’s also not the same as an OTC medication. You wouldn’t be able to purchase this type of product as simply as you could pick up a bottle of headache medication. According to the FDA, “consumers must successfully complete an extra step to see if the drug is right for them before buying or using a nonprescription drug with an ACNU.” (FDA) The extra step might involve watching a video, completing a digital questionnaire, or supplying results from a recent blood test, for example. But that extra step, in conjunction with consumer labelling, is meant to provide safe and structured nonprescription access for those who can appropriately use the medication without a doctor’s intervention. For those who need more support or evaluation, the traditional prescription pathway remains available.
Think about the implications for women’s health. For starters, ACNU could expand access to contraception without many of today’s state-specific barriers. It could improve access to vaginal estrogen for genitourinary syndrome of menopause. For groups that experience bias at the point of care, ACNU provides a pathway that could avoid negative interactions while promoting care seeking. It could reduce copays, eliminate unnecessary refill visits, and spare women from taking time off work just to maintain treatment. ACNU has the potential to improve access not only for conditions unique to women, but also for conditions that affect women differently, including cardiovascular disease, mental health conditions, migraine, osteoporosis, and autoimmune disease.
As at-home diagnostics continue to evolve, the possibilities become even greater. Imagine a woman prescribed an ACE inhibitor by her doctor who wants to try the nonprescription version of the same drug to help her stay adherent. Within an ACNU scenario, the additional condition may require her to periodically confirm that her blood pressure is still in range with no new symptoms. The choice of whether to get a prescription, which requires a doctor’s appointment and time off work, or whether to buy the nonprescription equivalent becomes easier to imagine when you consider the convenience of blood pressure monitoring at a local pharmacy or at home. The public health impact could be significant if consumers are incentivised to track their blood pressure over time. In that sense, ACNU could provide a valuable secondary impact to consumer and public health, as ACNU could help to extend healthcare monitoring into the self-care realm and provide genuine supports to adherence for chronic conditions.
Since prescription and nonprescription versions of the same therapy may be co-marketed under the ACNU rule, women could move more seamlessly between different levels of care as their needs change across life stages. There may be times in a woman’s life when her primary care physician should be more involved in her care, and times when self care is appropriate. That creates the potential for more continuous medication access, greater self-management, and more personalized support over time.
ACNU is more than a regulatory innovation. It is an opportunity to rethink how women access care. For too long, women’s health needs have been shaped by systems that can create unnecessary obstacles for them. By creating a new pathway to appropriate nonprescription access, ACNU can help remove some of the barriers that continue to stand between women and the care they need.
Its potential impact is significant. ACNU can empower women to take greater ownership of their health, expand access where provider or pharmacy access is limited, and support women where they are, at every stage of their life. From contraception to menopause care, and for conditions that disproportionately affect women, this pathway could make care more continuous, accessible, and equitable.
To be clear, ACNU is not about replacing clinicians. It is about creating a more flexible continuum of care that better reflects the realities of women’s lives. Through co-marketing with traditional prescription therapies, it can support both self-management and clinician-guided care, helping women access the right level of support at the right time.
If we are serious about advancing women’s health, we need to think differently about access. ACNU offers a new way forward, one that can unlock more equitable healthcare for the current generation of women and the generations that follow.
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Aleks Lyons is a Senior Director at Klick Health Consulting. She is a design leader with more than 25 years of experience. Her work marries strategic innovation, design research, behavioral science, and
emerging technologies.
Recently, Aleks co-authored an article in the Journal of Regulatory Affairs on the ACNU pathway with Paul Wardle, senior vice president of innovation consulting at Klick Health. He has more than 25 years of professional experience focused on consumer and patient-centric solutions to advance availability, access, and adoption of healthcare products by leveraging innovative regulatory and consumer engagement strategies, including ACNU NDA’s and Rx-to-OTC switch.
Wardle P, Lyons A. Transforming medication access: A novel regulatory pathway for increasing direct-to-consumer access. RAPS JOURNAL OF REGULATORY AFFAIRS. 2026;1(1):25-36. Published online 12 January 2026. https://www.raps.org/news-and-articles/News-Articles/2026/1/Transforming-medication-access-A-novel-regulatory
Klick are proud sponsors of the upcoming Women’s Health Week in NYC (May 13-14, 2026).
