At a time of unrelenting attacks on reproductive autonomy, the Food and Drug Administration’s decision on July 13 to approve a birth control pill for over-the-counter (OTC) use is an important advance toward providing people with tools to control their fertility. This includes preventing unwanted pregnancy. Having Opill, a safe, effective, easy-to-use birth control option available without a prescription is essential, because it so difficult for many people to get prescription birth control in the U.S.
As researchers and clinicians specializing in reproductive health care, we applaud the FDA for following the science and joining the more than 100 other countries, including Mexico and nations in most of South America, most of Central Asia and parts of Africa, that already allow people to buy birth control pills without a prescription. But how much the FDA decision will affect people’s ability to manage their reproductive lives in the U.S. will depend on what we and Opill’s maker, Perrigo, do to get these progestin-only pills into people’s hands when they are finally available, sometime in early 2024.
Our current health care system and the widespread stigma around sex create many barriers for people who want to avoid pregnancy. For some, the challenges in getting an appointment with a health care provider include the cost of a visit, a lack of insurance or an inability to take time off work. Being unable to see a clinician confidentially is another issue, particularly for minors or people in abusive or controlling relationships. The cost of a prescription can create another financial barrier. These barriers are even greater for those who face discrimination and judgment because of their racial or ethnic identity, sexuality, gender identity, disability, age, socioeconomic status or immigration status.
For example, youth report facing difficulties with scheduling appointments, a lack of transportation and stigma from parents and health care providers. In a national survey of young people, more than half reported that one or more of those barriers prevented them from getting birth control at all. Black and Latine people and those with low English proficiency also report being less likely to receive quality contraceptive counseling that focuses on their values and preferences. Black people specifically experience racism when receiving contraceptive care, including being pressured to use contraceptives. More than 50 percent of Black people in one study reported having had discriminatory experiences that reflected racialized stereotypes, such as being assumed to have multiple sexual partners. Transgender or nonbinary people who can become pregnant face discrimination and stigma and sometimes have health care providers who lack training in providing gender-inclusive care.
Having an over-the-counter birth control pill available removes many of these barriers for those wishing to prevent pregnancy. The approval of the OTC Opill is therefore a bright spot in an otherwise bleak landscape for reproductive autonomy in the U.S. It is not enough to merely have this medication approved, however, given the myriad barriers people face accessing and using any medication, including OTC medications. Government officials, health care systems and providers and advocates must make it easier to get Opill and any subsequent over-the-counter birth control options by making these medications affordable, easily available, simple to use and able to be dispensed without stigma or gatekeeping. This way we can ensure that all people in the U.S. who wish to can use this pregnancy prevention option.
Opill is a little different from other hormonal birth control pills, which typically combine progestin and a form of estrogen. While combined pills stop ovulation, leaving nothing for sperm to fertilize, progestin-only pills primarily work by thickening the cervical mucus, creating a barrier to prevent sperm from entering the uterus or fallopian tube to fertilize an egg. Progestin-only pills are very effective at preventing pregnancy and are associated with fewer health risks than combined pills, particularly with regard to blood clots. Some people taking these pills may have more irregular bleeding than with combined hormonal pills, but side effects such as breast tenderness and nausea are less common.
Progestin-only pills are not new. Clinicians already prescribe them for people who have underlying health conditions that affect their ability to tolerate an estrogen-containing pill and for people who have recently had a baby. Making the pills over the counter won’t increase the risk of someone with contraindications taking them. People can accurately identify the rare circumstances when they should not use the progestin-only pill using a simple checklist. And when it comes to people’s record of taking birth control pills consistently, OTC pill takers are just as consistent, if not more so, than people using prescription pills. These data show us that people of all ages are able to assess the risks and adhere to directions for taking birth control pills without the additional need for a health care provider to screen or counsel, just as they do when buying pain or allergy medications over the counter.
Intentional efforts to ensure this method is available to all who wish to use it must include these requirements:
- The FDA and Perrigo must ensure information about correctly using the pill is widely available, including what the potential is for side effects and how to manage them. This information needs to be understandable and in multiple languages.
- The FDA and pharmacists must make the pills available on shelves rather than behind the pharmacy counter. Pharmacies must additionally set up home delivery options to reduce marginalized peoples’ exposure to stigma and negative health care experiences.
- Perrigo must make this pill affordable. State and federal legislators need to mandate that private and state-based insurance plans cover this medication, as they do for other OTC medications, because over-the-counter medications can be more expensive for consumers than prescription drugs.
- The FDA must ensure that pharmacies and pharmacy employees do not create additional barriers to accessing these drugs through inaccurate information or shaming, as has happened with over-the-counter emergency contraception.
- The FDA, pharmacies, parents and society at large need to trust that young people, including adolescents, can make decisions about their health and ensure their access to the pill by not limiting availability via age restriction or ID requirement.
As we celebrate this win for reproductive autonomy, we must not lose sight of the broader fight. Everyone should have the ability to access the health care and medications they need to manage their reproductive health as they choose. Expanding access to birth control pills is a great step, but it is not enough. We must continue to work toward expansion of low-barrier essential health care access, including comprehensive sex education, access to the wide breadth of available prescription contraceptives and abortion care. As we watch the courts battle over mifepristone, an abortion medication known to be safe and effective, we hope that the FDA’s decision to approve Opill serves as a precedent and an inspiration to follow the scientific evidence in all aspects of reproductive health.
This is an opinion and analysis article, and the views expressed by the author or authors are not necessarily those of Scientific American.