This summer ushered in a wave of groundbreaking and long-overdue women’s health advancements amid a year rife with attacks on abortion care and reproductive freedom. On July 13, 2023, the U.S. Food and Drug Administration (FDA) made a landmark decision to approve the first hormonal birth control pill for over-the-counter (OTC) sale with no age restrictions. And just a few weeks later on August 4, the FDA approved the first oral medication to treat postpartum depression (PPD). Yet even with these remarkable innovations in women’s health and wellness, one persistent question remains: Will these drugs be affordable and accessible?
The approval of both medications marks a historic moment and a critical step forward for women’s health, with the possibility to transform access to health care for millions of women in the United States. As the manufacturers set out to determine prices for each of these drugs, they must put health over profits and consider the unique factors that facilitate and obstruct how women seek, obtain, and sustain the medical treatment they need. First and foremost, this means making these drugs affordable and mitigating one of Americans’ biggest barriers to receiving the care they need: prohibitive cost.
As the manufacturers set out to determine prices for each of these drugs, they must put health over profits and consider the unique factors that facilitate and obstruct how women seek, obtain, and sustain the medical treatment they need.
This moment is an opportunity for the pharmaceutical industry to push for equitable access to not only these medications but also new drug approvals in the future.
Facts about the two new FDA-approved drugs for women’s health
- Opill (norgestrel) is a progestin-only, daily birth control pill that has been used on a prescription basis for 50 years and, because it does not contain estrogen, carries a lower risk of blood clotting than other hormonal pill options.
- Research shows that birth control pills are safe and effective for over-the-counter use for people of all ages.
- OTC access may help reduce barriers by allowing women to receive hormonal birth control pills without having to first see a health care provider for a prescription.
- Opill is currently still prescription-only, and it is expected to appear on shelves in the first quarter of 2024. The manufacturer, Perrigo, has not yet said what price it plans to set for the product.
- Most birth control currently on the market can cost up to $50 per month without insurance.
- Zurzuvae (zuranolone) is a fast-acting, once-daily oral medication taken for 14 days to treat postpartum depression.
- Depression is one of the most common medical complications during and after pregnancy, affecting about 1 in 8 women.
- Making PPD treatment more attainable has the potential to improve maternal health and reduce the shame and guilt associated with PPD.
- Zurzuvae is expected to be commercially available by the end of 2023 after scheduling by the U.S. Drug Enforcement Administration.
- The only other FDA-approved drug for PPD, brexanolone, requires a 60-hour intravenous infusion in a hospital and has a list price of $34,000.
- Sage Therapeutics and Biogen have not revealed a list price yet. In August 2023, Sage Therapeutics announced its commitment to ensure that Zurzuvae is accessible to all women who need it “regardless of financial circumstances.” Some have speculated the cost could be high—and close to the cost of brexanolone—given that the drug was not approved by the FDA for treatment of major depressive disorder.
Drug affordability is particularly important for women
Drug affordability is a gender equity issue. The rising cost of prescription drugs and other medical expenditures has contributed to increased financial burden and medical debt for many Americans. Yet women often bear a greater financial burden when it comes to health care costs, and this burden disproportionately affects low-income women and women of color. In fact, 1 in 4 women report having had problems paying for their medical bills in the past year. Additionally, the Centers for Disease Control and Prevention (CDC) reports that in 2021, women were more likely than men to not take a medication as prescribed due to cost—9.1 percent compared with 7 percent. These financial barriers are only exacerbated by the wage gap, employer discrimination and bias, and the gender gap in caregiving responsibilities as well as other inequities that magnify disparities in care.
1 in 4
women report having had problems paying for their medical bills in the past year
During a time when women’s health care and rights are under the judicial microscope and on the legislative chopping block, it is unacceptable that millions of women cannot access and afford medicines that have the potential to drastically improve quality of life. Moreover, women’s health research is woefully underfunded, and women are significantly underrepresented in clinical trials, creating a staggering gap between this population and the innovation ecosystem. Researchers have estimated that even the slightest increase in funding for women’s health research could substantially improve health outcomes for women.
The time is now to fill these gaps.
Steps to make sure these drugs are affordable for all
Policymakers have already begun taking steps to tackle these issues. In late July 2023, for example, Sens. Mazie Hirono (D-HI), Patty Murray (D-WA), and Catherine Cortez Masto (D-NV) led a letter urging Perrigo to set a “low and affordable retail price” for Opill and posed several questions for the manufacturer. Additionally, in late September 2023, the departments of Health and Human Services, Labor, and the Treasury released a request for information (RFI) to gather information about the needs of agencies and the general public on coverage of OTC preventive products without a prescription.
It is unacceptable that millions of women cannot access and afford medicines that have the potential to drastically improve quality of life.
Drug manufacturers must not be allowed to stymie the promise of these medications. To start, manufacturers should release these drugs at a low and affordable price and work with other actors throughout the prescription drug system, such as pharmacy benefit managers and regulators, to ensure affordable coverage through health plans. For example, research shows that most adults are unwilling or unable to pay more than $15 per month for OTC contraception, and this number is even less for adolescents, at $10 per month. Manufacturers must take heed of such data and use it to inform their pricing decisions. This would help women and their families access needed and routine health care without delay and unnecessary barriers.
These advancements for contraception and postpartum depression come at a time when there is a renewed and heightened interest in protecting women’s health and expanding access to care. At the same time, the cost of medicine frequently remains too high and incompatible with those goals. Indeed, according to recent polling, 61 percent of U.S. adults take at least one prescription medication, and at least 30 percent say they haven’t taken their medicines as prescribed due to cost. Affordability is a ubiquitous issue. While these recent advancements are crucial milestones, the fight is far from over.
This is just the first in a series of steps to make women’s drugs more accessible and narrow existing gaps. Drug companies and policymakers must act with urgency to ensure that these drugs—and future ones—are affordable for all.
The author would like to thank Nicole Rapfogel, Andrea Ducas, Amina Khalique, and Maggie Jo Buchanan for their reviews of and contributions to this column.