Resources

Contraceptive Pearl: The Latest Updates on the Over-the-Counter Contraceptive Pill

By Joi C. Spaulding MD, MS

Opill, a daily progestin-only birth control pill (POP), was first approved for over-the-counter (OTC) use by the United States Food and Drug Administration (FDA) on July 13, 2023. As of March 2024, the pill is now available to people of all ages to purchase at retailers online and in stores nationwide, with no ID or prescription required. This groundbreaking move comes after decades-long organizing and advocacy led by the Free The Pill coalition to bring oral contraceptives over the counter in the United States and make contraception more accessible. This is the first oral contraceptive in the U.S. that does not require a prescription, and it is now the most effective form of OTC contraception available.¹

This OTC oral contraceptive pill is a progestin-only pill (POP) and contains 0.075mg of norgestrel, which is a synthetic progestin.² The pill should be taken at the same time every day and is considered to be effective two days after starting.³ Recent research suggests that for some progestin-only pill formulations, like Opill, if a pill is missed or delayed, the window for sustaining efficacy may be wider than 3-hours. If taken exactly as directed, the over-the-counter birth control pill is 98% effective in preventing pregnancy. However, with typical use, the efficacy is estimated to drop to 93%.³ Norgestrel 0.075mg pill is very safe for most people to take as contraindications to oral progestins are rare, such as breast cancer, severe cirrhosis, liver tumors, systematic lupus, having had malabsorptive bariatric surgery, and taking certain anticonvulsants or antimicrobial treatments.4-5 Research shows that people can accurately determine whether the OTC contraceptive pill is appropriate for them.6 For further details about the safety profile, risks, and eligibility criteria for POPs, check out this previous Contraceptive Pearl.

Although the FDA approval of an OTC oral contraceptive is a monumental step in expanding access to birth control, the cost of the pill can still be a barrier to use. The suggested retail price for Opill is $19.99 for a monthly supply, $49.99 for a three-month supply, and $89.99 for a six-month supply.3,7 Research shows that the highest amount the average person is willing to pay is around $15 for adults and $10 for teens. Additionally, about 15% of adults and 20% of teens cannot afford to pay anything.8 The OTC contraceptive pill is FSA/HSA eligible; however, it remains unclear if it will be covered by insurance without requiring a prescription, and coverage may vary by state and insurance plan. Access to contraception is a reproductive justice issue, and the out-of-pocket cost of Opill will disproportionately impact people of color and other marginalized communities that experience systemic oppression. While the manufacturers of the pill have introduced a cost assistance program, it will be important to ensure that this resource is easily available to all who need it.


RHAP Resources:

Your Birth Control Choices Fact Sheet

Progestin-Only Pill (Mini-Pill) User Guide

Progestin-Only Birth Control Sheet

Non-Prescription Birth Control Methods


Non-RHAP Resources:


Sources:

1. Over-the-Counter Access to Hormonal Contraception: ACOG Committee Opinion, Number 788. Obstet Gynecol. 2019;134(4):e96-e105. doi:10.1097/AOG.0000000000003473

2. Commissioner, O. of the. (2023b, July 13). FDA approves first nonprescription daily oral contraceptive. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive

3. “For Providers: Frequently Asked Questions about Opill.” Free the Pill, Mar. 2024.

4. American College of Obstetricians and Gynecologists. (2023, January). Progestin-only hormonal birth control: Pill and injection. American College of Obstetricians and Gynecologists.

5. CDC – Summary – USMEC – Reproductive Health. Published 2019. https://www.cdc.gov/reproductivehealth/contraception/mmwr/mec/summary.html

6. “Sober S, Bradford R, Henrie B, et al. Evaluation of consumer self-selection of a proposed over-the-counter, progestin-only daily oral contraceptive. Contraception. 2024;133:110401. doi:10.1016/j.contraception.2024.110401

7. “Opill®, Daily Oral Contraceptive Pill.” Opill, 2024, opill.com/products/opill?variant=47067484455216. Accessed 9 Apr. 2024.

8. Grindlay K, Grossman D. Interest in Over-the-Counter Access to a Progestin-Only Pill among Women in the United States. Womens Health Issues. 2018;28(2):144-151. doi:10.1016/j.whi.2017.11.006


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