Birth control pills
Birth control pills are the most commonly used form of reversible contraception in the United States, used by approximately 14 percent of women aged 15â49. (Some 18 percent of American women opt for sterilizationâtubal ligation, âtying their tubesââbut this is not considered a reversible method of birth control.) In the United States, two types of birth control pills (widely and generically called âthe Pillâ) are typically prescribed: combined estrogen-progestin (a synthetic form of progesterone) pills and progesterone-only pills (also called POP or minipills); combination pills are by far the more popularly used of the two types. The main difference between them is the presence of estrogen, which can adversely affect some women, such as those who are breastfeeding or have a history of high blood pressure, clotting issues, or migraines, making POPs a safer alternative for them. For both types, a single active pill is taken each day (at the same time of day for minipills) to prevent ovulation (the fertile period when pregnancy is possible) or to address other health concerns such as acne or endometriosis. Birth control pills are around 99 percent effective at preventing pregnancy when taken as prescribed, but their effectiveness drops when women forget to take them, increasing the risk of pregnancy. [120] [146]
The pills commonly come in either 21- or 28-day packs. When taking the former, after taking the 21 daily pills, the user takes nothing for 7 days, beginning a new pack on the eighth day. The 28-day pack contains 21 active pills and 7 placebo pills. (âPlaceboâ means something that soothes, and placebo pills are fake medication that look identical to real drugs but contain no active ingredient; they are commonly used in medical clinical trials to see if the real drug works better than merely the psychological belief of feeling better due to receiving medicationâa brain/body healing response called the âplacebo effect.â) The main purpose of the 7 dummy placebo pills is to maintain the daily habit of taking a pill, though their lack of any active ingredient will also will trigger a bleeding period similar to a menstrual cycle, also caused by not taking the pills for 7 days; the period is visual confirmation for the woman that she is likely not pregnant. The benefit of the 28-day pack is that the user maintains the daily habit of taking the pills, making the tracking of days unnecessary and facilitating the transition from one pack to the next. [146]
There are also âextended-cyle pills,â taken for an extended period, usually 84 consecutive days (about 12 weeks), followed by a 7-day break (with placebo or low-dose estrogen pills), resulting in a bleeding period only once every three months (four times a year). Low dose and ultra-low dose pills are combination pills that have a lower dose of estrogen, which can have fewer side effects, such as the risk of blood clots, for some women. There are also âcontinuous packs,â containing a daily pill for all 365 days of the year, which prevents a womanâs period entirely.[146] [152] [153]
While dozens of brand name and generic birth control pills are approved by the Food and Drug Administration (FDA) in the United States for prescription use, only oneâthe minipill Opillâhas been approved for over-the-counter (OTC) use. This means that the most widely used kind of birth control pillâthe combination pill, which is much more flexible in terms of when it can be taken each dayâis not available OTC, but only by prescription. Birth-control shots are also not available OTC.[146] [154]
Who uses the pill
About 65 percent of women aged 15-49 used some form of contraception in 2017-2019, which is the most recent data from the Centers for Disease Control (CDC). Among those women, female sterilization is the most popular form of birth control (18.1 percent). The second most popular is the Pill at 14 percent, followed by long-acting reversible contraceptives (LARCs) including intrauterine devices (IUDs) and implants at 10.4 percent, and male condoms (8.4 percent). CDC surveys found that white, college-educated, childless women 20â29 years old with higher incomes and private insurance were more likely to use the Pill and less likely to use female sterilization, though overall contraceptive use did not vary significantly across educational attainment. [120]
Women aged 40-49 use contraception at higher rates (74.8 percent) than younger women: 72.3 percent of women 30-39, 60.9 percent of women 20-29, and 38.7 percent of girls 15-19. Not surprisingly, use of birth control pills decreases with age (6.5 percent of women 40-49, 10.9 percent of those aged 30-39, 21.6 percent of those aged 20-29, and 19.5 percent of those aged 15-19). [120]
Globally, the United Nations found that of women aged 15-49 worldwide who use contraception, 15.7 percent used the birth control pill (compared to 14 percent in the United States) in 2022 (the most recent data). The most popular contraception remained female sterilization (22.9 percent), followed by the male condom (21.8 percent), and IUDs (16.8 percent). However, the Pill is the most popular form of contraception in Australia (38 percent), New Zealand (38 percent), Northern Africa (31 percent), Western Asia (31 percent), Latin America (26 percent), and the Caribbean (26 percent).[136]
How the pill works
There are two kinds of birth control pills: minipills (or POPs), which contain only progestin (a synthetic progesterone), and combination pills, which contain progestin and estrogen. In minipills and combination pills, progestin thickens the mucus in the cervix (making it difficult for sperm to enter the uterus), suppresses ovulation, and thins the lining of the uterus, all of which helps prevent pregnancy. According to the Mayo Clinic, minipills are often recommended for those who are breastfeeding, have certain health problems (such as blood clots), or are concerned about the side effects of estrogen. Risks and side effects of the minipill include unintended pregnancy (as many as 13 out of 100 users became pregnant in the first year of use), acne, irregular menstrual bleeding, depression, and decreased libido (sex drive), among others. [111] [112] [113]
Unlike minipills, the combination pill causes the body to maintain high levels of estrogen, which, when combined with progestin, lowers the levels of two other hormonesâfollicle-stimulating hormone (FSH) and luteinizing hormone (LH)âwhich in turn prevents the release of eggs for fertilization. The Mayo Clinic states that combination pills are recommended for more predictable menstrual cycles; relief from premenstrual syndrome (PMS), menstrual cramps, and acne; and decreased risk of ovarian and endometrial cancers and heavy menstrual bleeding. Risks and side effects of the combination pill include headaches, nausea, blood clots, and heart attacks, among others. [114] [115]
FDA path to over-the-counter (OTC) status
To change the status of a drug from prescription-based to over the counter, two paths can be taken by the drug manufacturer. In one option, the manufacturer submits an âOTC drug reviewâ to the FDA asking for OTC status consideration; groups of non-government experts then review the active ingredients in the prescription drug to determine if they are safe for OTC use. In the second option, the manufacturer submits new information via the new drug application process. In this option, the manufacturer submits studies to the FDA showing the label can âbe read, understood, and followed by the consumer without the guidance of a health care provider,â along with other information such as additional safety studies. [117] [118]
In both methods, if a drug is the first of its category to be switched to OTC status, the FDA asks a joint advisory committee that includes experts on that type of drug. The FDA then weighs the safety of the drug, whether consumers can follow the label directions without help, whether patients can diagnose themselves for the condition the drug treats, and whether the condition requires a medical exam or lab tests to use the drug over time. More than 100 drug ingredients and dosages have been moved from prescription to over-the-counter status since 1975. [117] [118]
Efforts to move birth control pills to OTC status
A February 23, 1993, scheduled FDA hearing on making the Pill available over the counter (OTC) was canceled just one week after it was announced. The meeting was partially organized by R.W. Johnson Pharmaceutical Research Institute, the research arm of Ortho Pharmaceutical Corporation that makes Ortho Novum, the best-selling Pill at the time. The FDA stated that the meeting was canceled because the agenda was not broad enough. [101] [102]
In 2006, Plan B, an emergency contraceptive that prevents pregnancy up to five days after sex, was approved for OTC sales to women age 18 and older. Opponents included conservative members of Congress and organizations like the Family Research Council, which stated, âWe think this is putting womenâs health at risk.â On June 20, 2013, the FDA approved Plan B One-Step for unrestricted OTC sales. The generic version was approved on February 25, 2014, for unrestricted OTC sales. In December 2022, amid the escalating abortion debate, the FDA clarified that Plan B is not an abortion drug: the Pill âwill not work if youâre already pregnant, and will not affect an existing pregnancy.â [81] [101] [103] [130]
In December 2012, the American College of Obstetricians and Gynecologists became the first major medical organization to endorse OTC birth control pills, stating, âWeighing the risks versus the benefits based on currently available data, OCs [oral contraceptives] should be available over-the-counter.â [104]
After the 2012 election some Republican lawmakers, including then-governor of Louisiana Bobby Jindal, promoted the idea of OTC birth control pills as an alternative to the Obamacare mandate that birth control be provided for free to insured women In 2015, Senators Cory Gardner (R-CO) and Kelly Ayotte (R-NH) proposed a bill to incentivize manufacturers to submit applications for OTC status to the FDA for women over age 17, including fast-track options and the waiving of the $1 million filing fee. A bill proposed by Senator Patty Murphy (D-WA), also in 2015, would have required that health insurance cover OTC birth control pills. Neither bill passed, and similar bills in subsequent years also stalled in Congress. [105] [106] [107] [108] [109]
FDA approval of first OTC birth control pill: Opill
In December 2016, Ibis Reproductive Health and HRA Pharma stated they would take the necessary steps to apply for OTC status for a birth control pill in the United States. [110]
HRA Pharma announced on July 11, 2022, that the company had submitted to the FDA the first application for an OTC birth control pill in the United States. Specifically, the application asked that Opill, a progestin-only daily birth control pill (also referred to as a minipill, POP, or non-estrogen pill), be switched from prescription-only to OTC. The drug had already been sold OTC in England under the brand name Hana. [128] [129]
On July 13, 2023, the FDA approved the request, making Opill the first OTC birth control pill in the United States. As Patrizia Cavazzoni, director of the FDAâs Center for Drug Evaluation and Research, said, âTodayâs approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States. When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy.â [131] [132] [133]
Opill began shipping to retail stores on March 4, 2024. A monthly supply of the progestin-only pill cost $19.99 in mid-2025; a three-month supply cost $49.99. [134]
Pros and Cons at a Glance
| PROS | CONS |
|---|---|
| Pro 1: Birth control pills are safe and offer additional health benefits. Read More. | Con 1: Women who take birth control pills without medical supervision can put themselves at risk. Read More. |
| Pro 2: OTC birth control pills would increase access to contraceptives for all women, including low-income and medically under-served populations. Read More. | Con 2: OTC birth control pills would be the least effective way to increase use of the best contraceptives. Read More. |
| Pro 3: OTC birth control pills could lower the rate of unintended and teen pregnancies, as well as the abortion rate. Read More. | Con 3: OTC birth control pills could result in more unwanted pregnancies. Read More. |
| Pro 4: Women are responsible and knowledgeable enough to care for their own bodies. Read More. | Con 4: OTC birth control pills would decrease privacy. Read More. |
Pro Arguments
(Go to Con Arguments)Pro 1: Birth control pills are safe and offer additional health benefits.
Plan B One-Step and other emergency contraception pills are available without a prescription and share the same active ingredient as daily birth control pills, levonorgestrel, but in a higher dose. The FDA has already indicated the safety of the drug by making Plan B available without prescription. [8] [9]
The Pill carries no risk of overdose or addiction, and globally many women use the drug with no problem. About 72.7 million American women of reproductive age (15-49 years) used the Pill between 2017 and 2019, the CDCâs most recent data. Furthermore, an overwhelming majority of the global population (80.29 percent) has access to OTC birth control pills. [1] [2] [3] [10] [120] [121]
Professor Eve Espey of the Department of Obstetrics and Gynecology at the University of New Mexico states, âNonsteroidal medicines kill far more people than birth-control pills.â In fact, other OTC drugs carry more serious risks. Non-steroidal pain pills (NSAIDS) like ibuprofen can cause stomach bleeding. Sudafed can raise blood pressure. Tylenol can cause liver toxicity. Antihistamines like Benadryl can worsen glaucoma and kidney disease. Diet pills can cause irregular heartbeats and raise blood pressure. This does not mean birth control pills have no side effects, but the side effects are no more serious than those of other OTC drugs. [6] [7]
âAs medications go, the pill is very safeâsafer than having a baby, driving, smoking, or taking daily aspirin,â explains Bedsider, a nonprofit online birth control network. As Joe Speidel of Bixby Center for Global Reproductive Health explains. pregnancy has a mortality rate about the same as car accidentsâone in 8,300âwhile the risk of dying from birth control is about one in 1,667,000, about the same as dying after being struck by lightning. [4] [5]
Furthermore, research indicates women who have access to OTC birth control pills are more likely to use the Pill continuously, whereas women who have to go through a doctor to get a prescription are more likely to miss pills between refills or another doctorâs appointment. Continuous use of hormonal birth control pills has also been shown to reduce or prevent anemia, irregular or heavy menstrual cycles, bone thinning, endometriosis, fibroids, acne, ectopic pregnancies, breast and ovarian cysts, PMS, menstrual migraines, pelvic inflammatory disease, and infections in the ovaries, fallopian tubes, and uterus. [19] [27] [28] [29]
Plus, according to the National Cancer Institute, using the Pill long term was associated with a 30 to 50 percent lower risk of ovarian cancer, a 15 to 20 percent lower risk of colorectal cancer, and at least a 30 percent lower risk of endometrial cancer. [26]
Not only are birth control pills safe for OTC use, they have the additional benefit of reducing the risk of or preventing other major health concerns.
Pro 2: OTC birth control pills would increase access to contraceptives for all women, including low-income and medically under-served populations.
A majority of American women (54 percent) agree that simplyhaving access to birth control has health benefits. [25]
About 19 million women live in âcontraception deserts,â places with one clinic or fewer per 1,000 women. Over 1.2 million of those women live in counties with no health center that provides the full range of contraceptive methods. Women in these deserts face long wait times, often three to six months, for any primary medical care, and even longer for gynecological care. An additional 11-21 percent of sexually active low-income women studied were more likely to use the Pill if it were available OTC. In these contraception deserts, women can more easily find a local drug store for medication than a doctorâs office. [3] [11] [12] [13] [137]
Even where healthcare is abundant, barriers to access exist for teens, the LGBTQ+ community, immigrants, and women of color, including parental consent, poverty, immigration status, discrimination, and language barriers. [3] [14] [15] [16] [22]
Furthermore, about 10 percent of American women ages 19â64 do not have health insurance and pay anywhere from $10 to $150 per month for prescription birth control pills. Plus, the average cost of a doctorâs visit to obtain a birth control pill prescription for an uninsured woman is $386. That doesnât include fees for other services that may be required such as a Pap smear ($39-125 on average), or associated costs (time off work, child care, etc.), all of which could be saved by popping into a pharmacy while running everyday errands. Opill, the birth control pill that went OTC in 2023, costs $15 to $20 a month, with no additional co-pays or doctorâs bills. [139] [140] [141]
Even for insured women for whom birth control is covered by health insurance, getting birth control by prescription has several associated costs that would be eliminated with OTC status, including co-pays for doctorâs visits, time taken off work to go to the doctor, and transportation and childcare fees. [38] [124]
Pro 3: OTC birth control pills could lower the rate of unintended and teen pregnancies, as well as the abortion rate.
About 54 percent of unintended pregnancies were associated with not using contraceptives and 41 percent with inconsistent use. Unintended pregnancies cost the U.S. federal and state governments $21 billion in 2010 (the newest numbers available) with the average cost-per-birth being $12,770 for prenatal care, labor and delivery, postpartum care, and 12 months of infant care ($20,716 for 60 months). The Guttmacher Institute estimated that $15.5 billion dollars could have been saved if the unintended pregnancies had been prevented. [1] [17]
Only 5 percent of unintended pregnancies happened while the woman used effective birth control consistently. Women who received a one-year supply of the Pill were 30 percent less likely to have an unplanned pregnancy and 46 percent less likely to have an abortion. A study comparing Pill use by women who obtained Pills with a prescription from a clinic in El Paso, Texas, with women who obtained Pills OTC from Mexico showed that the latter were more likely to continuously use the medication. [1] [18] [19]
OTC Pills can also help lower teen pregnancy rates. From 1991 to 2023, the nationwide teen pregnancy rate dropped almost 79 percent among 15- to 19-year-olds. Experts believe the drop is due to increased contraceptive use and delayed sexual activity. [20] [123] [142]
âDecades of research show that a majority of adolescents initiate sex before the age of 18 and that earlier use of contraception reduces the risk of teen pregnancy,â explains physician Krishna Upadhya. âGiving teens easier access to various contraceptives will not lead to more sex but would result in fewer unwanted pregnancies.â Teens may be more likely to use OTC birth control because taking the Pill is a daily routine and comes without the stress and angst tied to condom use.[21]
Finally, OTC Pills can lower the abortion rate. In a survey of women seeking abortions, 72 percent said they were pregnant because they could not get the contraception they needed, and 32 percent reported an institutional reason such as the prescription requirement. [22]
âThe most effective way to reduce abortion rates is to prevent unintended pregnancy by improving access to consistent, effective, and affordable contraception,â according to the American College of Obstetricians and Gynecologists. A âstrategy for improving access to contraception is to allow over-the-counter access to oral contraceptive pills.â [23]
Pro 4: Women are responsible and knowledgeable enough to care for their own bodies.
âMy main philosophy as someone who provides reproductive health care is to trust women to make their own decisions. The idea that they have to [have a] conversation with a doctor to decide which method is best for them seems overly paternalistic and unnecessary,â argues physician Alison Block. [30]
Often, doctors will only prescribe birth control pills once a patient has visited and had a pelvic exam with a cancer screening. However, Pap smears (the HPV and cancer screening test) are now recommended every three years instead of every year and only after a woman has turned 21. Obstetrician Nancy Stanwood states, âWe were holding pregnancy prevention hostage to cancer screening. Theyâre both worthwhile goals, but one should not be held hostage to the other.â [31]
Women can sort out for themselves whether hormonal birth control is right for them. A study showed that 98 percent of women came to the same conclusion as their doctors about whether they could use hormonal birth control. However, the women were more cautious about âcontraindicationsâ (medical reasons not to take a drug) such as headaches, smoking, and potential pregnancy than their doctors were. The Border Contraceptive Access Study found that women who got the Pill OTC from a pharmacy in Mexico were adequately self-screening for contraindications. [32] [33]
Of reproductive age women surveyed, 77 percent indicated that they were in favor of OTC Pills, with 56 percent strongly favoring the option. A majority of recent birth control pill users (60 percent) favored OTC pills and would be likely to use them. However, even most women (52 percent) who have not used any contraception in the past year favor OTC Pills and 29 percent would use them. Thatâs almost a third of reproductive-age women not using contraception who would do so if the Pill were available OTC. [147]