What the new FDA approval of an over-the-counter birth control pill means

Last week, the Food and Drug Administration (FDA) approved a brand of oral contraceptive for over-the-counter sales, making it available for purchase without needing a prescription as of 2024. This first-of-its-kind approval in the United States paves the way for other oral birth control options to be sold in stores without needing a prescription to purchase.

“This decision is significant,” says Alison Packard, MD, obstetrician and gynecologist in the Department of Obstetrics and Gynecology (OB/GYN) at Massachusetts General Hospital. “Oral birth control is a more effective method of contraception compared to the other options currently available over the counter — namely condoms and spermicides.”

For patients who do not have easy access to a health care provider, over-the-counter oral birth control will dramatically improve their ability to effectively and safely prevent pregnancy.

“To imagine that a person who does not have the time, opportunity or insurance coverage to schedule a visit with a provider can walk into a pharmacy and purchase a pack of pills just as easily as a pack of condoms is thrilling—and long overdue,” says Dr. Packard. “We are hopeful that someday it will also be easier to access options such as the combination birth control pill, the contraceptive ring, and contraceptive injections.”

The approved contraceptive is often called the "minipill," because it contains only the hormone progesterone rather than both progesterone and estrogen. Without estrogen, there is a lower risk of blood clots or high blood pressure. There are few reasons a person should not take this pill.

“Those who have ever had breast cancer should avoid hormonal birth control because of concerns that these medications might increase the risk of recurrence,” says Beverly Moy, MD, MPH, clinical director of the Breast Oncology Program at the Mass General Cancer Center and breast cancer expert who participated in the FDA Advisory Committee meeting.

Physicians caution that the progesterone-only pill needs to be taken at the same time every day, and that it is common to experience irregular bleeding after starting this pill. You should reach out to your health care provider if you experience side effects after starting this pill.

“Thinking about which method of birth control is best for you depends on many factors,” says Dr. Packard. “A conversation with your physician or other health professional can help you evaluate the risks and benefits of the various methods in the context of your specific health history.”

What is the right birth control for me?

Tip #1: Think about your birth control or family planning needs

If you're planning to use birth control to prevent pregnancy, it's important to consider your family planning needs, your health conditions, how easy a method is for you to use, and any other goals you have (for example, improving or eliminating your periods or treating migraines). If all your needs are considered, then you’re more likely to end up with the method that works best for you for the long-term.

For patients who cannot access a health care provider for more personalized birth control counseling, taking the progesterone-only pill is a very safe and more effective option than using condoms alone for pregnancy prevention.

Learn more about birth control options >

Tip #2: Talk with your PCP about which form of birth control is right for you.

There are several birth control options, each with its own set of advantages and disadvantages. Birth control pills effectively prevent pregnancy and can treat several medical conditions, including heavy and painful periods, menstrual migraines, endometriosis and premenstrual dysphoric disorder. They need to be taken every day and cannot be taken if you have certain medical conditions such as blood clots, breast cancer or high blood pressure. Intrauterine devices (IUDs) and implants also treat these medical conditions and are more effective than the birth control pill but require an office visit to insert and remove.

Talking with your primary care provider (PCP) or OB/GYN specialist can help you determine if the over-the-counter progesterone-only birth control pill, or one of these other options, is best for you. While you will need an appointment for this type of counseling, it can be done virtually without needing to come into the office.

Tip #3: Continue to get regular reproductive health care check-ups.

Even though this over-the-counter birth control pill will allow people to get safe and effective birth control without needing a doctor visit, some reproductive health care can only be provided in a clinic, such as Pap smears, screening for sexually transmitted infections, evaluating causes of abnormal bleeding and pelvic pain, and accessing more effective, long-term birth control like IUDs and implants.

Tip #4: Those with a history of breast cancer should avoid hormonal birth control.

Those with a history of breast cancer should avoid hormonal birth control because of concerns that these medications might increase the risk of the cancer returning. These concerns come from preclinical research, which is research that occurs before clinical trials involving humans.

There is limited data in the clinical setting, particularly for progesterone-only pills. One small study suggests that neither oral contraceptives containing progesterone and estrogen, nor IUDs increase the risk of breast cancer recurrence. However, these data are not sufficient to establish safety, so doctors recommend that patients with a history of breast cancer should not take oral contraceptives.