Unmet need

One in 7 sexually active women do not use contraception.15 Learn more about the barriers they face and the impact of unintended pregnancy.

Current barriers to contraception access16,17

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Prescription requirement

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Inability to take time off work or school to visit a medical provider

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Difficulty traveling to healthcare clinics

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Lack of clinics offering full range of contraceptive options

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Inability to pay for contraceptive method

Lack of knowledge and misinformation are common among consumers and providers

Worries about health risks

Many individuals have unfounded worries about oral contraceptives carrying major health risks or incorrectly believe that the pill is an abortifacient.18

Misperceptions about exams

13% of women who ever tried to obtain a prescription for hormonal contraception reported requirements for a healthcare visit, examination or Pap test as a barrier to contraceptive access, although progestin-only pills do not require examinations before initiation.4,9

Privacy concerns

Adolescents often think there are parental notification procedures in place and don’t realize their privacy may be protected by federal regulations.18

Woman holding question mark sign

Pelvic and breast examinations, cervical cancer screening, and sexually transmitted infection screening are not required before initiating hormonal contraception and should not be used as reasons to deny access to hormonal contraception.9

ACOG

How these barriers affect women

More than 19 million women of reproductive age live in a contraceptive desert.19 Research has found that millions of people eligible for publicly funded contraception have no reasonable access to a full range of birth control methods near them.19

01

1.2 million

Roughly 1.2 million women live in counties without a single clinic that offers a full range of contraceptive methods.19

02

~1/3

Approximately 1/3 of women trying to access oral contraceptive pills, patches or rings report difficulty obtaining prescriptions or refills17, or that they simply couldn’t get their next supply of contraception in time.15

03

~50%

Almost half of women at risk for unintended pregnancy reported not using contraception due to barriers to access.8 
01

1.2 million

Roughly 1.2 million women live in counties without a single clinic that offers a full range of contraceptive methods.19

02

~1/3

Approximately 1/3 of women trying to access oral contraceptive pills, patches or rings report difficulty obtaining prescriptions or refills17, or that they simply couldn’t get their next supply of contraception in time.15

03

~50%

Almost half of women at risk for unintended pregnancy reported not using contraception due to barriers to access.8 

Impact of unintended pregnancy

About 45% of pregnancies in the US are unintended.7 An unintended pregnancy, compared with an intended pregnancy, can be associated with:

  • Delayed or reduced prenatal care22-26
  • Less likelihood of starting or continuing breastfeeding24,26
  • Increased rate of low birthweight babies, preterm births and worse maternal outcomes25,27
  • Higher rates of maternal depression27-29

There is high demand for an OTC option

83%

83% of 665 people who used Opill in a clinical study said they would be likely to use a progestin-only pill if it was available OTC.20

77%

Findings from the 2022 KFF Women’s Health Survey indicate 77% of women of reproductive age support making oral contraceptives available OTC.21

World Image

With the approval of Opill, the US will join over 100 other countries in providing access to oral contraception without a prescription.30

Learn more about Opill

References

1. Trussell J, Aiken ARA, Micks E, Guthrie KA. Efficacy, safety, and personal considerations. In: Hatcher RA, Nelson AL, Trussell J, Cwiak C, Cason P, Policar MS, Edelman A, Aiken ARA, Marrazzo J, Kowal D, eds. Contraceptive technology. 21st ed. New York, NY: Ayer Company Publishers, Inc., 2018.
2. US Food and Drug Administration. FDA approves first nonprescription daily oral contraceptive. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive. Accessed October 13, 2023.
3. US Food and Drug Administration. Opill® label. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017031s041lbl.pdf. Accessed October 13, 2023.
4. Curtis KM, et al. U.S. Selected Practice Recommendations for Contraceptive Use, 2016. MMWR Recomm Rep. 2016;65(4):1-66.
5. Centers for Disease Control and Prevention. National Survey of Family Growth 2017-2019. Available at: https://www.cdc.gov/nchs/nsfg/nsfg_2017_2019_puf.htm. Accessed July 26, 2023.
6. Data on file. HRA Pharma. Unpublished analysis of the NSFG data by Pinney Associates 2023.
7. Finer LB, Zolna MR. Declines in unintended pregnancy in the United States, 2008–2011. N Engl J Med. 2016;374(9):843-852.
8. Biggs MA, et al. Unprotected intercourse among women wanting to avoid pregnancy: attitudes, behaviors, and beliefs. Womens Health Issues. 2012;22(3):e311-e318.
9. American College of Obstetricians and Gynecologists. ACOG Committee Opinion Number 788: over-the-counter access to hormonal contraception. Obstet Gynecol. 2019;134(4):e96-e105.
10. Han L, et al. Mechanism of action of a 0.075 mg norgestrel progestogen-only pill 2. Effect on cervical mucus and theoretical risk of conception. Contraception. 2022;112:43-47.
11. Glasier A, et al. Mechanism of action of norgestrel 0.075 mg a progestogen-only pill. I. Effect on ovarian activity. Contraception. 2022;112:37-42.
12. Curtis KM, et al. U.S. Medical Eligibility Criteria for Contraceptive Use, 2016. MMWR Recomm Rep. 2016;65(3):1-104.
13. US Food and Drug Administration. Opill (0.075mg oral norgestrel tablet) information. Available at: https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/opill-0075mg-oral-norgestrel-tablet-information. Accessed October 13, 2023.
14. Raine-Bennett T, et al. Ectopic pregnancy prevention: further evidence of benefits of prescription contraceptives. Contraception. 2022;105:19-25.
15. Frederiksen B, et al. Women’s sexual and reproductive health services: key findings from the 2020 KFF Women’s Health Survey. Available at: https://www.kff.org/womens-health-policy/issue-brief/womens-sexual-and-reproductive-health-services-key-findings-from-the-2020-kff-womens-health-survey. Accessed May 25, 2023.
16. Key K, et al. Challenges accessing contraceptive care and interest in over-the-counter oral contraceptive pill use among Black, Indigenous, and people of color: an online cross-sectional survey. Contraception. 2023;120:109950.
17. Grindlay K, Grossman D. Prescription birth control access among U.S. women at risk of unintended pregnancy. J Womens Health (Larchmt). 2016;25(3):249-254.
18. American College of Obstetricians and Gynecologists. Committee Opinion Number 615: access to contraception. Obstet Gynecol. 2015;125(1):250-255.
19. Power to Decide. Tip sheet: understanding contraceptive deserts. Available at: https://powertodecide.org/what-we-do/information/resource-library/understanding-contraceptive-deserts. Accessed April 26, 2023.
20. Grindlay K, et al. Interest in continued use after participation in a study of over-the-counter progestin-only pills in the United States. Womens Health Rep (New Rochelle). 2022;3(1):904-914.
21. Long M, et al. Interest in using over-the-counter oral contraceptive pills: findings from the 2022 KFF Women’s Health Survey. Available at: https://www.kff.org/womens-health-policy/issue-brief/interest-using-over-the-counter-oral-contraceptive-pills-findings-2022-kff-womens-health-survey. Accessed November 16, 2023..
22. Cheng D, et al. Unintended pregnancy and associated maternal preconception, prenatal and postpartum behavior. Contraception. 2009;79(3):194-198.
23. Dibaba Y, et al. The effects of pregnancy intention on the use of antenatal care services: systemic review and meta-analysis. Reprod Health. 2013;10:50.
24. Lindberg L, et al. Pregnancy intentions and maternal and child health: an analysis of longitudinal data in Oklahoma. Matern Child Health J. 2015;19(5):1087-1096.
25. Mohllajee AP, et al. Pregnancy intention and its relationship to birth and maternal outcomes. Obstet Gynecol. 2007;109(3):678-686.
26. Kost K, Lindberg L. Pregnancy intentions, maternal behaviors, and infant health: investigating relationships with new measures and propensity score analysis. Demography. 2015;52(1):83-111.
27. Maxson P, Miranda ML. Pregnancy intention, demographic differences, and psychosocial health. J Womens Health (Larchmt). 2011;20(8):1215-1223.
28. Fellenzer JL, Cibula DA. Intendedness of pregnancy and other predictive factors for symptoms of prenatal depression in a population-based study. Matern Child Health J. 2014;18(10):2426-2436.
29. Abajobir AA, et al. A systemic review and meta-analysis of the association between unintended pregnancy and perinatal depression. J Affect Disord. 2016;192:56-63.
30. Grindlay K, et al. Prescription requirements and over-the-counter access to oral contraceptives: a global review. Contraception. 2013;88(1):91-96.
31. Joint Meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee. Laboratoire HRA presentations. Available at: https://www.fda.gov/media/167980/download. Accessed June 5, 2023.
32. American Medical Association. AMA urges FDA to make oral contraceptive available over-the-counter. Available at: https://www.ama-assn.org/press-center/press-releases/ama-urges-fda-make-oral-contraceptive-available-over-counter. Accessed November 2, 2023.
33. Society for Adolescent Health and Medicine. SAHM statement: over-the-counter status for oral contraceptives. Available at: https://www.regulations.gov/comment/FDA-2022-N-1959-0557. Accessed November 2, 2023.
34. North American Society for Pediatric and Adolescent Gynecology. NASPAG statement to FDA on over the counter OCPs 2022. Available at: https://naspag.memberclicks.net/assets/docs/NASPAG%20Statement%20to%20FDA%20Over%20the%20Counter%20OCPs.pdf. Accessed October 20, 2023.
35. US Food and Drug Administration. Opill tablets. Prescribing information. Laboratoire HRA Pharma; 2017. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017031s035s036lbl.pdf. Accessed October 13, 2023.