On July 13, 2023, 50 years after its initial approval for prescription use, norgestrel (Opill®) became the first daily oral contraceptive approved by the US Food and Drug Administration (FDA) for use as over-the-counter (OTC) birth control in the United States.1 This approval will change the way that people who can become pregnant access contraceptive care, especially in states where abortion is restricted or banned.
US History & OTC Birth Control
To understand the significance of this decision by the FDA, the approval of Opill for OTC use must be placed in a historical context.
From the Civil War to the Turn of the Century
Up until the Civil War, abortion was a common practice.2 Black women, some enslaved, provided half of all reproductive care at this time as midwives, along with Indigenous and White women. Ironically, prior to 1865, enslaved Black women were prohibited by their owners from undergoing abortions.
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Starting in the 1860s in an attempt to take authority away from the midwives performing abortions, a coalition of male physicians pushed for states to outlaw the practice.2 Abortion was outlawed nationwide by 1901, with some exceptions for life-saving procedures.2,3
Association for the Study of Abortion
In 1955, Planned Parenthood convened with physicians to discuss the growing problem of deaths resulting from illegal abortions.3 The organization encouraged lawmakers to change abortion laws to permit physicians to provide safe abortions. The Association for the Study of Abortion was created in 1964, working together with physicians and groups like Planned Parenthood to advocate for legal abortion for all.
Roe v. Wade
By the time the Supreme Court ruled on Roe vs Wade in 1973, Alaska, Hawaii, New York, and Washington had repealed their abortion bans and 13 other states expanded access.3 The Supreme Court ruled that the right to abortion was constitutionally protected by the 14th Amendment, protecting this right in all 50 states.
This historic decision changed the landscape of reproductive health in America and was met with significant pushback from individuals and groups that opposed abortion.3 In 1976, the Hyde Amendment restricted the use of federal funds by Medicaid for abortion services, a move that disproportionately affected marginalized communities.
Although many states maintained their Medicaid abortion funds, the Hyde Amendment started a period of slow chipping away at abortion access.3 These changes were possible under Roe vs Wade, as the ruling only addressed the right to an abortion, not access to one.
In the decades following Roe vs Wade, antiabortion politicians worked to appoint antiabortion judges and justices to US courts.4 This effort culminated with the 2022 Supreme Court ruling in Dobbs vs Jackson Women’s Health Organization to overturn Roe vs Wade. This decision immediately limited abortion access across the United States, with 18 states banning or restricting abortion access within months of the ruling.
Opill Approval & OTC Birth Control
At a time when abortion is restricted or banned in many states, the approval of Opill represents an important milestone for post-Roe reproductive rights. Even in states where abortion remains legal, getting an appointment with a physician and attending that visit to obtain a prescription for contraception can be challenging.5
Over-the-counter availability of Opill removes these barriers and should improve access to pregnancy prevention for many people.6
Opill Efficacy & Safety Considerations
The FDA initially approved Opill for prescription use in 1973.7 Opill is a progestin-only oral contraceptive that is highly effective at preventing pregnancy when taken daily at the same time without interruption. Initial clinical trials demonstrated an efficacy of 98% in participants who followed this regimen and used backup contraception if they were delayed in taking their pill.
OTC Birth Control Contraindications for Opill
Opill is considered safe for people who could become pregnant, with the exception of people with certain medical conditions or those who take certain medications.7 Unlike estrogen-containing contraception, progestin-only pills like Opill also carry a much lower risk for venous thromboembolism (VTE). According to the manufacturer, Opill is contraindicated for people with current or past breast cancer, known or suspected pregnancy, abnormal uterine bleeding, acute liver disease, and benign or malignant liver tumors.8
Drug-Drug Interactions for Opill
Drug interactions to consider with Opill include hepatic enzyme-inducing drugs like phenytoin, carbamazepine, barbiturates, rifampin, efavirenz, bosentan, and St John’s wort.8 When taken with Opill, these agents may reduce the effectiveness of the oral contraceptive. Nonhormonal backup contraception should be used when Opill is taken with these agents and continued for 28 days after discontinuing them or another hepatic enzyme inducer.
For people who take these agents chronically, another contraceptive method should be considered.
The efficacy of Opill and ulipristal acetate, an emergency contraceptive, may be reduced if Opill is taken within 5 days of taking ulipristal acetate.8 After taking ulipristal acetate, people should wait at least 5 days to resume Opill and use backup contraception reliably until their next menstrual period.
Supporting Patient Autonomy
Because Opill is the first OTC oral contraceptive approved in the United States, physicians may feel uncertain about patients taking this medication without their approval. However, research demonstrates that people who can become pregnant are capable of self-screening to determine their hormonal contraceptive eligibility, and the American College of Obstetricians and Gynecologists (ACOG) supports OTC oral contraception access without age restrictions.9 Therefore, physicians should be reassured of their patients’ capacity to make this autonomous reproductive health decision.
However, OTC availability does not guarantee affordability.1 Additionally, although the Affordable Care Act requires insurers to cover prescribed contraceptives, this requirement is not in place for OTC products. Taken together, experts are concerned that Opill may be prohibitively expensive without insurance coverage or controlled costs. Physicians should consider advocating for affordable costs to support patient access to OTC oral contraceptives.
OTC Birth Control: Next Steps
The approval of Opill has the potential to significantly improve access to oral contraceptives for the many people who can become pregnant, and physicians are uniquely positioned to support its use. As Opill becomes available in pharmacies, physicians can work together with their pharmacy colleagues to educate people about Opill and provide guidance about other options when needed.1
Physicians may also consider advocating for expanded access to OTC oral contraceptives, including combined oral contraceptives, as well as medroxyprogesterone acetate, an injectable contraceptive. Most importantly, physicians should support their patients’ contraception health choices, whatever those may be.
Physicians can learn more about OTC access to hormonal contraception from the ACOG committee opinion, available here.
This article originally appeared on MPR.
References
- Hartman, M. Why the FDA’s approval of Opill matters — and what’s next. Johns Hopkins Bloomberg School of Public Health. Published July 13, 2023. Accessed July 31, 2023.
- Abortion is central to the history of reproductive health care in America. Planned Parenthood. Published 2022. Accessed July 31, 2023.
- Historical abortion law timeline: 1850 to today. Planned Parenthood. Published 2022. Accessed July 31, 2023.
- Roe v. Wade overturned: How the Supreme Court let politicians outlaw abortion. Planned Parenthood. Published 2022. Accessed July 31, 2023.
- Musa A. The FDA approved the US’ first over-the-counter birth control pill. What happens next? CNN. Published July 21, 2023. Accessed July 31, 2023.
- FDA approves first nonprescription daily oral contraceptive. News release. US Food and Drug Administration. Published July 13, 2023. Accessed July 31, 2023.
- Opill (0.075mg oral norgestrel tablet) information. US Food and Drug Administration. Published online July 14, 2023. Accessed July 31, 2023.
- Opill® . Prescribing Information. Laboratoire HRA Pharma; 1973. Accessed July 31, 2023.
- Over-the-counter access to hormonal contraception. The American College of Obstetricians and Gynecologists. Published October 2019. Accessed July 31, 2023.
