5 Important Facts About Over-the-Counter Birth Control Pills

What You Should Know
  • The overturning of Roe v. Wade has accentuated the critical need for accessible contraceptive care.

  • An FDA advisory panel will convene in November 2022 to consider HRA Pharma’s application to make Opill the first birth control pill available over the counter in the United States.

  • Policy should follow the lead of more than 100 other countries and take this important step to improve contraceptive options for women across the country.

In the months since the US Supreme Court overturned Roe v. Wade, the state of reproductive health in the United States—including access to contraceptive care—has moved to the forefront of public consciousness. Expanding access to the full range of contraceptive options will not negate the need for abortion care services, but contraceptive care is a critical access point to ensure that women can plan their pregnancy and to improve access to comprehensive reproductive health and rights. This includes expanding access to hormonal contraception, which is the most common form of reversible contraception in the United States.

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The most common reason for using contraception is to prevent pregnancy, but many women also use hormonal contraceptive pills to manage other medical conditions—such as irregular periods, menstrual pain, and acne—further reinforcing the importance of having access to contraception. Unfortunately, many women and other people who use contraception—some studies estimate up to one-third of adult women—report experiencing barriers when seeking contraceptive care. These barriers include, but are not limited to, financial problems and incapacity; lack of transportation; living in rural areas or underserved communities; cultural and linguistic differences from their providers; and many more. In addition, 19 million women of reproductive age live in contraceptive deserts, which are counties where the number of health centers offering a range of methods is insufficient to meet the needs of the county’s number of women eligible for publicly funded contraception. Furthermore, Black women and other women of color face heightened barriers when seeking contraceptive care – especially Black women, who have faced decades of misinformation and coercive and unethical practices related to contraceptive access.

Contraceptive care is an important access point to ensure that women can plan their pregnancies and to improve access to comprehensive reproductive health and rights.

And overturning of Roe, a long-standing effort to advocate ‘expanding contraceptive access by securing over-the-counter approval has gained renewed attention. This past July, HRA Pharma took a small step in this direction when it submitted a first-of-its-kind application to the US Food and Drug Administration (FDA), seeking approval to sell Opill over the counter without a prescription. The Opill 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. If approved, it would be the first hormonal contraceptive pill sold OTC in the United States. Another pill manufacturing company – Cadence Health – is reportedly close to submitting an application for approval of its combined progestin-estrogen contraceptive pill. For more information on the types of oral contraceptive pills, see the text box below.

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The OTC FDA approval process is long, taking about 10 months to complete. As a result, the general public will likely not see any movement until mid to late 2023. Regardless, the public should be aware of the impact of this app on contraceptive access.

Types of oral contraceptives

There are three types of oral contraceptive pills: combination, progestin-only, and extended-release and continuous pills. The following describes the types of pills available along with examples, how they work, and a typical daily regimen for users.

Combination pills
  • Contains two hormones, estrogen and progestin
  • Examples are Beyaz, Loestrin, Yaz, and Yasmin
  • How it works:
    • Stops the ovaries from releasing eggs
    • Thickens cervical mucus, stopping sperm from reaching the egg
    • Thins the lining of the uterus to prevent implantation of a fertilized egg
  • Regimen:
    • For daily use
    • Comes in 21-, 24-, or 28-day packs
    • 21 or 24 active hormone pills followed by the remaining inactive or low-dose pills
The progestin-only pill
  • Contains only the hormone progestin
  • Examples include Norenthindrone (Micronor) and Norgestrel
  • How it works:
    • Thickens cervical mucus, stopping sperm from reaching the egg
    • May stop ovaries from releasing eggs (less often)
  • Regimen:
    • For daily use
    • Only 28 days package
    • All pills are active
Extended-release and continuous pills
  • Contains estrogen and progestin
  • Examples include Lybrel, Quasense, Seasonale, and Seasonique
  • How it works:
    • Stops the ovaries from releasing eggs
    • Thickens cervical mucus, stopping sperm from reaching the egg
    • Thins the lining of the uterus to prevent implantation of a fertilized egg
  • Regimen:
    • For daily use
    • Usually the pack is 91 days
    • 84 days of active hormone pills followed by seven inactive pills and / or low-dose pills

1. Support for and interest in OTC oral contraceptive pills is widespread and growing

As noted above, the oral contraceptive pill is the most common form of reversible contraception in the United States. Data from the 2017-2019 National Survey of Family Growth shows that 65 percent of women aged 15 to 49 use contraception. The most commonly used contraceptive methods were “female sterilization (18.1 percent), oral contraceptive pills (14 percent), long-term reversible contraception (10.4 percent), and external condoms (8.4 percent). This number varies across racial groups, and current use is higher among non-Hispanic white women (17.8%) than among Hispanic (7.9%) and non-Hispanic Black (8.1%) women. Use also varies by age group, with younger women using contraception at higher rates than older women. The National Survey of Family Growth provides a complete snapshot of contraceptive use in the United States.

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Women’s health advocacy groups and major medical organizations have supported the fight to make the oral contraceptive pill available for years. In fact, almost three dozen medical organizations-including the American Medical Association, the American College of Obstetricians and Gynecologists (ACOG), and the American Academy of Family Physicians-have signed a statement supporting OTC contraception without age restrictions. Additionally, in March, 59 members of the US House of Representatives Pro-Choice Caucus wrote to FDA Commissioner Robert Califf urging the agency to approve the pill for OTC consumption.

Importantly, research shows that women of reproductive age are more likely to make birth control available OTC. A 2011 survey of a nationally representative sample of US women aged 18 to 44 (n = 2,046) found that among all respondents, 62 percent said they “strongly or somewhat in favor” of oral contraceptives being available OTC. In addition, a 2015 online survey of interest in OTC progestin-only contraception found that 39 percent of adult women and 29 percent of teenagers reported that they would likely use the pill, especially if covered by insurance. Furthermore, most voters support “birth control pills to be sold over the counter,” and two-thirds of voters believe that the FDA should “prioritize the sale of birth control pills over the counter.”

2. Oral contraceptive pills meet FDA standards for OTC sale

As mentioned above, the FDA process is designed to demonstrate that consumers can understand and follow OTC labels. According to ACOG, “the potential toxicity of a medication and whether the medication can benefit the consumer without jeopardizing their safety” are the main factors the FDA considers to make the medication OTC. Labels and instructions must be understood without the presence of a healthcare provider. Packaging should also outline the benefits and risks to the user’s health. Leading medical organizations have reiterated that a prescription is not clinically necessary for access to the pill. It is non-toxic, non-addictive, and poses no risk of overdose, meeting FDA criteria for OTC access. In fact, other OTC medications to relieve cold, flu, and allergy symptoms carry higher risks.

3. Consumers can accurately assess their eligibility to use contraceptive pills and use them effectively

Consumers have been safely using the pill for 60 years. And years of research have shown that women can accurately understand the label and eligibility criteria to use oral contraceptive pills. A study found that self-screening for contraindications to oral contraceptives using a medical checklist is relatively accurate, with about 7 percent of women in the sample mistakenly thinking they were eligible for use. This is similar to the level of accuracy of examinations and screenings guided by health care providers. The authors determined that the provision of OTC oral contraceptives would likely be safe, especially for young women and with blood pressure screenings. In addition, a 2019 systematic literature review found that not only women can accurately assess the feasibility and contraindications for use, but also determined that OTC access can encourage continued use and minimize interruptions in treatment.

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4. Oral contraceptive pills have been available OTC in other countries for many years

When it comes to reproductive access, the United States is falling behind the rest of the world. OTC contraceptive pills are available in more than 100 countries, mostly in Latin America, Africa, and European countries. A 2013 study of data from 147 countries found that oral contraceptives were informally available without a prescription in 38 percent of countries; legally available without a prescription (no screening by a health professional required) in 24 percent of the country; legally available without a prescription (screening required) in 8 percent of the country; and available only by prescription in 31 percent of the country. The United States is one of the few countries that still does not have at least one OTC contraceptive pill option. US policymakers can look to other countries’ models for implementation to help strengthen and improve access.

5. Policymakers should expand the range of options available to buy OTC

A 2012 study found that a relatively small proportion of women who use contraceptives use the progestin-only contraceptive option. Still, because this option generally presents lower risks and rarer contraindications to consumers, it can be a good first attempt to make it available OTC. Perhaps just as important, making Opill available OTC can be used as a springboard to make other options available.

Cost is also a major factor: More consumers are interested and willing to use progestin-only contraception if it has lower out-of-pocket costs. Policymakers should be mindful of this fact and work to keep costs low, including ensuring that OTC birth control methods can be covered by insurance.

conclusion

Making oral contraceptive pills available over the counter is an important strategy to increase the bodily and reproductive autonomy of women and all people who can become pregnant. This is especially important for people who currently face many barriers when trying to access care, especially at a time when threats to gender equity and reproductive health are emerging. While FDA approval will not fully address these disparities, making contraceptives accessible OTC at low cost will mark a significant step forward for access.

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