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.