On July 13, The U.S. Food and Drug Administration made history by approving the first-ever birth control pill for sale without a prescription. OTC Opill, which is identical in formula to a prescription contraceptive approved half a century ago, is expected to reach the market early next year.
This marks a crucial step in improving reproductive healthcare access across the United States. In 2011, 2.8 million of the 6.1 million pregnancies in the United States were unintended. National surveys have shown that the need for a prescription often hinders women’s access to contraception, or causes interruptions in their medication usage. Eliminating these roadblocks is essential to decrease the financial, physical, and psychological burden of unplanned and unwanted pregnancies—a goal that has become all the more urgent since the overturning of Roe v. Wade.
With support from the Templeton World Charity Foundation, Cadence Health aims to make OTC birth control accessible for all women. For the last six years, Cadence Health has been working with the FDA to gain approval for Zena, a combination oral contraceptive (COC).
While Opill is a progesterone only pill (POP), also known as a “minipill,” Zena contains both estrogen and progesterone to prevent ovulation and pregnancy. More than 90% of the 10 million women using oral contraceptive pills today are prescribed COCs. Minipills are safer for women at risk of blood clots, but have a higher risk of user error as they must be taken within the same three-hour window each day to reliably prevent pregnancy.
“We should provide what people are already using safely, not shoehorn them into a medication option that is not their first choice,” said Cadence co-founder Dr. Robert (Nap) Hosang, MD MPH MBA. “We see the mini-pill approval as a good first step. It opens the door for the next logical step, which is approval of the combination hormone birth control pill that 90% of women on oral birth control take.”
The American College of Obstetricians and Gynecologists supports OTC sale of combination hormone birth control. While contraceptives containing estrogen are unsafe for certain individuals—those already at risk of dangerous blood clots—research shows that women are capable of assessing which option is appropriate for their needs if risks are stated clearly. ACOG also notes that the risk of deep vein thrombosis due to combined oral contraceptive use is miniscule compared with the increased risk of the same condition during pregnancy and the postpartum period.
“The responsible action is to try to make the directions to consumers about using COCs as safe as possible, which means informing those at risk for complications from the estrogen in the pill to avoid using it at all—for example, people who smoke cigarettes, or who have high blood pressure,” explained Dr. Hosang.
The FDA ruling is still “momentous for access to contraception,” Dr. Hosang added. “POPs and COCs made available OTC are each more effective than any other OTC product available today. The most effective today is the condom, and women have little control over their use. It’s time for women to have access to that same level of control.”
Since 2018, the TWCF has provided $3.5 million USD in grant funding to support Cadence’s mission. Cadence has worked to create easy-to-understand OTC labels that test well with adolescents and women with low literacy, and aims to begin trials of its OTC pill in the near future.
“TWCF has helped us ride out the many stalls that the program has endured from the regulatory authorities,” Dr. Hosang said. “Without the assistance from TWCF and its commitment to improving the well-being of all people, our plight would have been much more arduous.”
TWCF supports increased access to reliable contraception as a means of achieving human flourishing. OTC oral contraceptives have the potential to decrease unintended pregnancies, reduce the risk of maternal death for young mothers, and allow more women to complete their education and have the opportunity to pursue careers before having children.
“Getting birth control should not be a stressful process,” Dr. Hosang said. “It’s great to have the support of an organization like TWCF as we work toward our goal of contraceptive access for everyone everywhere.”
