Facts

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

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)

CAI’s collection of expert-led explainer videos includes: 

The pill OTC

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

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

• The roadmap to affordable contraception

• Everything you need to know about the combined oral contraceptive (COC)

• The path to FDA approval for the combined oral contraceptive (COC)

Challenging myths about birth control

• Challenging myths about birth control

Fighting misinformation and disinformation 

• Fighting disinformation about pregnancy and contraception

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)

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 digital label for the COC pill that will allow consumers to scan a QR code in the store using their phone, or via URL on a computer. This will take them to a page that answers health-related questions, based on the drug facts label (DFL). This will assist consumers with correct self-selection, by clarifying if Zena is right or not right for the consumer. If it’s right, the consumer will see a barcode that can be taken to the cashier to purchase. If it’s not right, the message will say something like “You cannot purchase it at this time. Please talk to a doctor to see if you can use Zena.”

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. In 2015, the FDA began the review process for a switch to OTC status for two types of birth control pills: the progestin-only birth control pill, often called the “mini-pill,” which was approved for OTC status in July 2023; and the combined oral contraceptive (COC), which is currently making its way through the approval process. As of March 2024, Opill, the “mini-pill,” arrived on store shelves and online, and this form of the pill can now be purchased by consumers of all ages, without a prescription.

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?

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.