What You Should Know
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The overturning of Roe v. Wade has accentuated the critical need for accessible contraceptive care.
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An FDA advisory panel will convene in November 2022 to consider HRA Pharma’s application to make its Opill the first daily birth control pill available over the counter in the United States.
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Policymakers should follow the lead of more than 100 other countries and take this important step toward improving contraceptive options for women across the country.
In the months since the U.S. Supreme Court overturned Roe v. Wade, the dire state of reproductive health care in the United States—including access to contraceptive care—has moved to the forefront of public awareness. Expanding access to the full range of contraceptive options would not negate the need for abortion care services, but contraceptive care is a critical access point for ensuring that women can plan their pregnancies and for improving access to comprehensive reproductive health and rights. This includes expanding access to hormonal contraceptives, which are the most common form of reversible contraception in the United States.
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The most common reason for using contraceptives is to prevent pregnancy, but many women also use hormonal contraceptive pills to manage other medical conditions—such as irregular menstruation, menstrual pain, and acne—further reinforcing the importance of having access to contraceptives. 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 concerns and unaffordability; lack of transportation; living in a rural area or underserved community; cultural and linguistic differences from their providers; and more. Additionally, 19 million women of reproductive age live in contraceptive deserts, which are counties where the number of health centers offering the full range of methods is not enough 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 contraception access.
With the overturning of Roe, advocates’ long-standing efforts to expand contraceptive access by securing over-the-counter approval has gained renewed attention. This past July, HRA Pharma took one small step in this direction when it submitted a first-of-its-kind application to the U.S. Food and Drug Administration (FDA), seeking approval to sell its 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 about the types of oral contraceptive pills, see the text box below.
The FDA OTC approval process is lengthy, taking around 10 months to complete. As a result, the general public likely will not see any movement until mid- to late 2023. Regardless, the public should be aware of the impact these applications may have on contraceptive access.
Types of oral contraceptives
There are three types of oral contraceptive pills: combination, progestin-only, and extended- and continuous-use pills. The following describes the types of pills available along with examples, how they work, and the typical daily regimen for users.
Combination pill
- Contains two hormones, estrogen and progestin
- Examples include Beyaz, Loestrin, Yaz, and Yasmin
- How it works:
- Stops ovaries from releasing eggs
- Thickens cervical mucus, stopping sperm from reaching the egg
- Thins the uterine lining to discourage 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
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 frequent)
- Regimen:
- For daily use
- Only 28-day packs
- All active pills
Extended- and continuous-use pills
- Contains estrogen and progestin
- Examples include Lybrel, Quasense, Seasonale, and Seasonique
- How it works:
- Stops ovaries from releasing eggs
- Thickens cervical mucus, stopping sperm from reaching the egg
- Thins the uterine lining to discourage implantation of a fertilized egg
- Regimen:
- For daily use
- Typically 91-day packs
- 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 show that 65 percent of women ages 15 to 49 were using contraception. The most common contraceptive methods used were “female sterilization (18.1 percent), oral contraceptive pills (14 percent), long-acting reversible contraceptives (10.4 percent), and the external condom (8.4 percent).” These numbers vary across racial groups, with current use “higher among non-Hispanic white women (17.8%) than among Hispanic (7.9%) and non-Hispanic Black (8.1%) women.” Use also varies across age groups, with younger women using contraceptives at higher rates than older women. The National Survey of Family Growth provides a full snapshot of contraceptive use in the United States.
Women’s health advocacy groups and major medical organizations have supported the fight to make oral contraceptive pills available over the counter 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 in support of OTC contraception without age restrictions. Additionally, in March, 59 members of the U.S. House of Representatives Pro-Choice Caucus wrote to FDA Commissioner Robert Califf urging the agency to approve the pill for OTC consumption.
Importantly, research demonstrates that women of reproductive age overwhelmingly are in favor of making birth control available OTC. One 2011 survey of a nationally representative sample of U.S. women ages 18 to 44 (n=2,046) found that among all respondents, 62 percent said they were “strongly or somewhat in favor” of oral contraceptives being made available OTC. Additionally, a 2015 online survey of interest in OTC progestin-only contraception found that 39 percent of adult women and 29 percent of teens 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 the FDA’s standards for OTC sale
As mentioned above, the FDA process was designed to demonstrate that consumers can accurately understand and follow OTC labels. According to ACOG, “the potential toxicity of the medication and whether the medication can benefit consumers without endangering their safety” are the main factors the FDA considers to make a medication available OTC. Labels and instructions must be understandable without the presence of a health care provider. Packaging must also outline the benefits and risks to the user’s health. Leading medical organizations have reaffirmed that a prescription is not clinically necessary for access to the pill. It is not toxic, not addictive, and has no risk of overdose, meeting the 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 for using contraceptive pills and use them effectively
Consumers have safely been using the pill for 60 years. And years of research have shown that women can accurately understand the labels and eligibility criteria for using oral contraceptive pills. One 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 incorrectly thinking they were eligible for use. This is similar to the accuracy rate of health care provider-guided assessments and screenings. The authors determined that OTC provision of oral contraceptives would likely be safe, especially for younger women and with blood pressure screenings. Additionally, a 2019 systematic review of the literature found that not only are women overwhelmingly able to accurately assess their eligibility and contraindications for use, but it also determined that OTC access may encourage continued use and minimize disruptions in care.
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 American, African, and European countries. A 2013 study of data from 147 countries found that oral contraceptives were informally available without prescription in 38 percent of countries; legally available without prescription (no screening by a health professional required) in 24 percent of countries; legally available without prescription (screening required) in 8 percent of countries; and available only by prescription in 31 percent of countries. The United States is one of the few countries that still does not have at least one OTC contraceptive pill option. U.S. policymakers can look to other countries’ models for implementation to help strengthen and improve access.
5. Policymakers must expand the range of available options for OTC purchase
A 2012 study found that a relatively small proportion of women who use contraceptives use the progestin-only pill option. Still, because this option generally presents lower risks and rarer contraindications to consumers, it may be a good first attempt to make available OTC. Perhaps equally important, making the Opill available OTC could function as a springboard to making other options available.
Cost is also a major factor: More consumers are interested in and willing to use progestin-only contraception if it has little to no out-of-pocket cost. Policymakers should be mindful of this fact and work to keep costs low, including ensuring that OTC methods of birth control can be covered by insurance.
Conclusion
Making oral contraceptive pills available over the counter is one important strategy for increasing the bodily and reproductive autonomy of women and all people who can become pregnant. This is particularly important for people who currently face myriad barriers when trying to access care, especially in a time with emerging threats to gender equity and reproductive health. While FDA approval would not fully address these disparities, allowing contraceptives to be accessed OTC at low costs would mark a significant step forward for access.
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5 Important Facts About Over-the-Counter Birth Control Pills - Center For American Progress
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