Facts

A medical overview of the first over-the-counter birth control pill

How does the “mini-pill” – soon on store shelves – differ from other birth control pills?

Opill, the first FDA-approved oral contraceptive available over the counter, is close to being for sale on store shelves. Here, Dr. Raegan McDonald-Mosley — CEO of Power to Decide, chief medical advisor for Contraceptive Access Initiative and one of the nation’s top medical leaders on access to reproductive health — shares some need-to-know facts about this “mini-pill” and explains what differentiates it from other types of hormonal birth control.

Dr. Raegan McDonald-Mosley is not financially affiliated with any pharmaceutical company, including Opill.

Everything you need to know about the first over-the-counter birth control pill

In 2024, Opill arrived on store shelves and can be purchased without a prescription. In this video, Dr. Raegan McDonald-Mosley — CEO of Power to Decide, chief medical advisor for the Contraceptive Access Initiative and one of the nation’s top medical leaders on access to reproductive health — talks about what’s really in this little pill, its safety, and what the medical community thinks about it. Dr. McDonald-Mosley also predicts the significant opportunities Opill’s launch will offer to millions of people in the U.S. who face systemic barriers to reproductive health care, including living in contraceptive deserts, economic inequities, and more.

Dr. Raegan McDonald-Mosley is not financially affiliated with any pharmaceutical company, including Opill.

Facts in the video:

Birth control pills have a 50-year safety record, with decades of research reinforcing safety of the pill. (Sept. 14, 2023: “Over-the-Counter Oral Contraceptive Pills,” KFF)

Bringing the birth control pill over the counter will increase access for the more than 19 million people who live in contraceptive deserts, without close proximity to a clinic that offers the full range of contraceptive methods. (June 2022: “Reproductive Well-Being: A Framework for Expanding Contraceptive Access,” American Journal of Public Health)

The safety of oral contraception for all ages is well established. The FDA first approved the pill over 60 years ago.

Several studies have already successfully demonstrated that women can utilize self-screening tools to determine whether the pill is right for them.

Like many over-the-counter pharmacy products, some people with certain medical conditions should not choose the pill and may need to consult medical professionals. Research has shown that people can accurately identify if the pill is a safe option for them. These facts are consistent with over-the-counter safety standards.

The American Medical Association has endorsed the pill over-the-counter.

“Providing patients with OTC access to the birth control pill is an easy call from a public health perspective as the health risks of pregnancy vastly outweigh those of oral contraceptive use.”

— American Medical Association Board Member David H. Aizuss, M.D.

 

In a media landscape permeated with misinformation and disinformation about reproductive health, it is crucial to distinguish facts from myths. In this video, Dr. Raegan McDonald-Mosley, CAI’s chief medical advisor and Power to Decide’s chief executive officer, debunks six such myths and provides clarity about the birth control pill, which is backed by decades of scientific research underscoring its safety and effectiveness.

 Facts in the video:

“After a person stops taking the pill, the ability to become pregnant comes back almost immediately, and the ability to get pregnant should be the same as it was before taking the pill.” (Mayo Clinic)

“Emergency contraception does not cause abortion.” (ACOG)

“Oral contraception may lower a person’s overall risk of cancer by providing protection against some forms of cancer such as ovarian cancer, uterine cancer, and colon cancer, ”  (American Journal of Obstetrics & Gynecology) and “Hormonal birth control may cause a small increase in the risk of breast cancer, but the overall risk of breast cancer among hormonal birth control users remains very low.” (ACOG)

“Overall, most people report no change in mood after starting the pill.”

(See all CAI explainer videos on our YouTube channel)

The Need for Access for all

The pill is the most popular form of reversible contraception in the United States. In an average month, approximately 14% of American women of reproductive age use the contraceptive pill and 82% of sexually active women have ever used the pill.

In a 2014 poll, three out of four women in America said that the birth control pill is one of the most important medical advances of the last century and has had a positive impact on women’s day-to-day lives.

According to American Medical Association Board Member David H. Aizuss, M.D.:

“Access is one of the most cited reasons why patients do not use oral contraceptives, use them inconsistently, or discontinue use. Expanding OTC access would make it easier for patients to properly use oral contraceptives, leading to fewer unplanned pregnancies.”

Ensuring affordable access to over-the-counter contraception is essential. National expert and CAI co-founder Dana Singiser explains the roadmap to affordability:

See the roadmap to affordability here.

Learn more at thepillotc.org/affordability.

Frequently Asked Questions

HOW DOES THE PILL GET APPROVED TO GO OVER THE COUNTER?

Click here for details on the FDA approval process.

WHEN WILL THE PILL GO OVER THE COUNTER?

Two birth control pills — the progestin-only mini-pill and the combined oral contraceptive pill — have sought over-the-counter status. After a lengthy FDA process, one birth control pill, the mini-pill, was approved for over-the-counter use, and another is undergoing review:

  • The pHRA Pharma’s progestin-only mini-pill, especially useful for those with certain health conditions, was approved for over-the-counter sales in July 2023. This is a progestin-only pill — the same type of medication as emergency contraception, which is already available over the counter for all ages.

  • The most common birth control pill, a combined oral contraceptive (COC), taken by 95% of pill users in the United States, is expected to finish the FDA review process within a few years. This pill contains both estrogen and progestin. The makers of this pill are developing a novel technology solution to help consumers screen for safety.

WHAT DOES “OVER THE COUNTER” MEAN?

Removing a prescription requirement means that people can directly access a product on a store shelf. This is different from pharmacist-access, available in many states, where a pharmacist can approve the sale of prescription over-the-counter birth control pills. The two pharmaceutical companies that submitted applications to the FDA (one of which, Perrigo, received approval on bringing a mini-pill over the counter in 2024) pursued a “switch” from prescription status to over-the-counter status. This means the birth control pill will be directly accessed by consumers of all ages on the store shelf starting in 2024 with Opill.

ISN’T IT BEST TO HAVE A MEDICAL SCREENING BEFORE TAKING THE PILL, JUST IN CASE?

Thousands of medications are currently available over the counter with important safety information, including headache, allergy and cold medicine. People should have access to safe medications, like the contraceptive pill, without unnecessary barriers. People should also have access to healthcare so they can choose to have medical screenings and consultations when needed.

WILL WOMEN WITH HYPERTENSION BE AT AN INCREASED RISK?

Unintended pregnancy may present a greater threat to women with hypertension than birth control use. According to ACOG, “The VTE (Venous thromboembolism) risk with combined oral contraceptive use is small compared with the increased risk of VTE during pregnancy and the postpartum period.” Label studies reviewed by FDA will prove that women are able to understand the medical risks associated with the pill.

WILL PEOPLE WHO PURCHASE THE PILL OVER THE COUNTER BE ABLE TO UNDERSTAND AND FOLLOW THE LABEL INSTRUCTIONS?

Several studies have demonstrated that people are capable of using self-screening tools for over-the-counter birth control.

A provider visit is not the only way, nor the most efficient way, for people to receive information and counseling about contraceptive methods. Websites, apps and community-based education are places where people can get information about oral contraceptives.

WILL PATIENTS FOREGO SEXUAL AND REPRODUCTIVE HEALTH PREVENTIVE CARE IF THEY NO LONGER NEED AN OFFICE VISIT FOR BIRTH CONTROL?

Not necessarily. Research suggests large majorities of women — roughly nine in 10 — get screenings such as Pap tests and breast exams even if they are not using birth control. One robust study showed that nine in 10 women with OTC access still obtained Pap tests, pelvic exams and breast exams.

Study authors concluded, “Our results are encouraging that women would continue to obtain necessary preventive screening if OCs were available OTC in the USA. If barriers to access are an important reason why women fail to obtain recommended screening, it is likely that the prescription requirement for OCs only limits their access to contraception, rather than improving their access to screening.”

WILL ELIMINATING A DOCTOR’S VISIT TO OBTAIN THE PILL MEAN THAT PEOPLE WILL NOT GET IMPORTANT COUNSELING?

People who most benefit from over-the-counter access may not have access to provider counseling visits. Making safe contraception more accessible is likely to increase the number of people who can successfully plan their pregnancies. 

Over-the-counter access does not prevent those with access to health care from getting counseling on different options.