The relevance of the first over-the-counter birth control pill in U.S.

Experts see the U.S. FDA’s approval of Opill as a way to ‘off-set’ the abortion restrictions placed by the overthrow of 60-year-old Roe v. Wade protections

July 26, 2023 04:16 pm | Updated July 28, 2023 10:02 am IST

The U.S. Food and Drug Administration recently approved the daily contraceptive Opill as the first non-prescription over-the-counter birth pill. Image for representational purpose only.

The U.S. Food and Drug Administration recently approved the daily contraceptive Opill as the first non-prescription over-the-counter birth pill. Image for representational purpose only. | Photo Credit: Reuters

In a landmark decision, the U.S. Food and Drugs Administration (FDA) on July 13 approved the first birth control pill that can be purchased over the counter without prescription — nearly 60 years after birth control was first introduced in the U.S. The once-a-day Opill will expand access to a safe method of contraception in an increasingly stifling reproductive health landscape, barricaded with abortion restrictions and infrastructure gaps. The American Medical Association (AMA) called the decision a “monumental step” in ensuring people “can effectively limit unintended pregnancies and manage family planning”.

“Since losing legally protected access to abortion care [under Roe v. Wade], there has been a frenzy of activity around restoring and enhancing reproductive care,” explains Sanjam Ahluwalia, a Women’s and Gender Studies professor at the Northern Arizona University, Flagstaff.  FDA’s decision comes “in response to the urgency of the moment, anything that can extend and ensure greater contraceptive protection for larger numbers”.

What is Opill?

The Opill, or the ‘mini pill’, is a progestin-only pill (POP) using a synthetic version of the hormone progesterone called norgestrel. The typical combination birth control pill contains a formulation of both progesterone and estrogen. Opill’s story goes back to 1973 when norgestrel was first approved for use in the U.S., but combination pills soared in popularity.

Opill uses low doses (0.075-milligram) of progestin to thicken the cervical mucus and thin the uterus’s lining, blocking the sperm from the cervix. POPs also stop ovulation in some cases (40% of women continued to ovulate, according to the American College of Obstetricians and Gynaecologists).

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The nonprescription approval means the over-the-counter pill for women will be made available in pharmacies — just like over-the-counter condoms, aspirin and other drugs. Women and people can access the pill without consultations from a primary physician or gynaecologist. The Ireland-based manufacturer Perrigo Company said Opill will be made available in the U.S. in early 2024. Taken correctly, only two in 100 women get pregnant in their first year of taking norgestrel (a 98% efficacy), according to the FDA.

POPs require discipline and sincerity. “Opill should be used daily, at the same time and continuously till one wants the contraceptive effect,” explains Ankita Gharge, a gynaecologist. The effect of the pill is for roughly 24 hours. If delayed by more than three hours, the person needs to take backup birth control for two days, she adds.

Difference between a combination and progestin-only pill (POP). Photo Credit: The Hindu

Difference between a combination and progestin-only pill (POP). Photo Credit: The Hindu

OPs are advised for those with breast feed, are estrogen-intolerant, have a history of blood disorders, high blood pressure and heart problems.

“FDA’s approval means we will have one more option to give to people who are seeking contraception. In certain conditions, they are more effective and have lesser side effects [such as for breastfeeding mothers],” Dr. Gharge says.

The FDA advised against using Opill alongside hormonal birth controls — oral contraceptive tablet, vaginal ring, contraceptive patch, contraceptive implant, contraceptive injection or an intra-uterine device (IUD). Like other minipills, Opill is not an emergency contraceptive (which prevents pregnancy after unprotected sex).

FDA scientists previously flagged that the minipill is not suitable for people with a history of breast cancer and undiagnosed vaginal bleeding. Other side effects include irregular menstrual bleeding, headaches, decreased libido, dizziness, nausea, acne, increased appetite, abdominal pain, cramps or bloating, per the FDA. Medicines that interact with Opill can result in decreasing its efficacy, potentially resulting in unintended pregnancy. 

Opill is currently sold without a prescription in the United Kingdom. India made birth control pills an over-the-counter drug in 2005 to tackle unwanted pregnancies and unsafe abortions. More than 15.1 crore people opt for oral birth control pills globally, as per a 2019 United Nations report. Pills were also found to be the dominant contraceptive method in 13 countries, followed by injectables and male condoms and female sterilisation. 

Opill vs. Combination pills

Hormonal birth control pills change the level of the natural hormones the body makes. They vary by mode of action and directions of use.

Combination pills are varied: there is a mixture of ‘active’ and ‘inactive’ (placebo, where there are no hormones) pills. One common type is 21 active pills and seven inactive pills. POPs, on the other hand, have a fixed composition of progestin in their 28-pill pack. The failure rate of is the same as that of combined pills, a study shows.

“POPs are more effective than the non-prescription forms of contraception,” says Dr. Gharge. “The failure rate is much lesser than methods like condoms.” Oral contraceptive pills do not have protection against transmission of HIV and AIDS, and other sexually transmitted infections (STIs), for which barrier contraceptives such as condoms are advised. “People can use POPs in combination with condoms,” she adds.

People’s choice of pills will depend on one’s health profile, their desired contraceptive duration and their need to prevent sexually transmitted infections. Estrogen reduces the quantity of milk produced, making combination pills an unfavourable option for women who breastfeed. Estrogen levels in the first combination birth control pills circa 1960s were as high as 150 micrograms; pills today contain 10-35 micrograms.

The rule of thumb, says Dr. Gharge, is to consult a doctor to find the right contraceptive. 

Global prevalence of birth control pill usage. “Contraceptive Use by Method 2019”. Photo Credit: United Nations

Global prevalence of birth control pill usage. “Contraceptive Use by Method 2019”. Photo Credit: United Nations

How safe is Opill?

FDA based its decision on eight U.S. clinical studies, which examined 2,173 women, 53% of whom were Caucasian and 47% African American, between the ages of 15 to 49 years. The pill was safe and effective in “almost 30% of subjects in the clinical trials who were under 20 years of age”, the FDA stated. Opill’s use is currently not indicated for postmenopausal women.

A review of the literature around minipill’s efficacy also found “norgestrel 75 µg/day is highly effective in clinical use, with similar estimates of failure in breastfeeding and non-breastfeeding women, providing support to the case for approval over-the-counter.”

FDA scientists previously cited concerns that minors and people with limited literacy may not adhere to label instructions, and overlook side effects. There is also a tendency to over-indulge in OTC birth control pills, mentions Dr. Gharge, adding that a lack of awareness about different contraceptives restricts women from making informed choices. India is the third largest market for emergency contraceptives, one estimate showed. 36% of respondents to a survey also thought the morning after-after pill could be used as a regular contraceptive, hinting at a knowledge gap that has stretched in the absence of sex education.

Label instructions on OTC pills thus function as a guiding star. The manufacturer H. R. Pharma demonstrated that consumers were able to use the product effectively relying only on the drug labelling, without any outside consultation, the FDA confirmed. A health panel in May said the public health benefits of making a nonprescription birth control pill available outweigh the “limited number of risks from the medication itself”. 

“While it is important patients maintain relationships with their physicians to stay up to date on screenings, requiring an office visit to begin birth control is an unnecessary hurdle for patients who must take time off work, find childcare, and travel to appointments.”American Medical Association

“Contraceptive Use by Method 2019”. Photo Credit: United Nations

“Contraceptive Use by Method 2019”. Photo Credit: United Nations

A reproductive health ‘milestone’

Opill is a triumph on two fronts: the minipill is another option for safe contraception, and its OTC availability eliminates obstacles of bias, money, time and distance, besides stigma. Black women were more likely than white women to use a contraceptive method associated with lower efficacy, such as condoms, or no contraceptive at all, due to systemic barriers and discrimination. Globally, reports show how one’s gender, class, caste, immigrant status determine access to reproductive services.

OTC pills carve new routes of access in the path to reproductive autonomy; conversations with gynaecologists and physicians can be pitstops. Experts await details on cost and health insurance coverage, concurring that Opill will have to meet the benchmark of affordability to live to its promise.

The ecstatic response is also a product of the “fraught moment” in U.S. history, where the approval is a way to offset the abortion restrictions placed by overthrowing Roe v. Wade’s protection, Prof. Ahluwalia adds. Restricting abortion care, while making contraceptives inaccessible, would lead to unwanted pregnancies that people would be forced to carry to term. The United Nations Population Fund March 2022 report found almost half of all pregnancies globally (totalling 12.1 crore each year) are unintended; more than 60% of these end in abortion and 45% of all abortions are unsafe.  

The road ahead

“Reproductive rights are not on neutral ground. It has not been resolved anywhere,” Prof. Ahluwalia notes. India, for instance, offers access to OTC pills and has extended abortion care to women irrespective of marital status, but contraceptive use remains the lowest among women from marginalised communities. The National Family Health Survey-5 found the burden of family planning responsibility falls mostly on women. Although abortion is legal, a report found 67% of abortions in India are unsafe. Entrenched stigma, shortage of doctors, public health gaps feed into contraceptive inequities.  

“The Indian story is not one of feminist empowerment in contrast to what’s occurring in the U.S.,” she says. Women still struggle to exercise control over their reproductive bodies, because “contraceptive technologies for over a century have focused on women as users”.

Activists say OTC access to pills cannot be viewed in isolation. Efforts to develop an inclusive vocabulary — which articulates the need for sex education, affordable and safe contraceptives, and reproductive care — must follow. 

“When birth control pills were introduced in the U.S., it was a big moment where women were able to join the workforce in larger numbers. There was a certain empowerment, a freedom that women got from having access to the pill,” Prof. Ahluwalia says. The conversation has mockingly come full circle: “In 2023, we are at a point where women are singularly burdened with the responsibility of contraceptive usage.” 

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