Statement of Purpose

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The Oral Contraceptives (OCs) Over-the-Counter (OTC) Working Group is a coalition of reproductive health, rights, and justice organizations, nonprofit research and advocacy groups, university-based researchers, and prominent clinicians who share a commitment to providing all women of reproductive age easier access to safe, effective, acceptable, and affordable contraceptives.

The working group is focused on the potential of OTC access to OCs to reduce disparities in reproductive health care access and outcomes among low-income, poor, and young women, and to increase opportunities for all people to access a safe, effective method of contraception, free of unnecessary gatekeeping by the health care system, as part of a healthy sexual and reproductive life.

The prescription requirement for hormonal contraception is an access barrier for some, including those who lack health insurance, as well as those who are insured but face other obstacles such as difficulties getting to a health facility or expenses related to taking time off for a clinic visit. Additionally, young women and immigrant women report cultural and linguistic barriers to accessing quality, comprehensive reproductive health services, and these barriers can make prescription access challenging [1]. Although the passage of the Affordable Care Act (ACA) has improved contraceptive access for millions of US women [2], not all women are covered under health care reform, including some immigrants and low-income people in states that have not expanded Medicaid under the ACA. Further, some houses of worship that oppose contraceptive coverage are exempted from the ACA benefit, and women who receive health coverage through such organizations may not get contraceptive coverage. In addition, evidence from settings where contraception is available free of charge indicates that barriers to access persist when a prescription is required, and that women in these settings are interested in OTC access [3, 4].

The substantial literature available on OCs confirms they meet the Food and Drug Administration’s (FDA) criteria for OTC status. At a population level, the drug’s benefits outweigh the risks for women of reproductive age; the potential for misuse or abuse is low; a consumer can easily self-diagnose the condition for which the pills are indicated; and directions for use are straightforward. Because progestin-only pills (POPs) have fewer contraindications than combined oral contraceptive pills (COCs), we are pursuing an OTC switch for a POP first. Progestin-only emergency contraception (EC) is already available without a prescription for people of all ages in the United States [5]. Both POPs and COCs are very safe and we believe that both types of pills should ultimately be available over the counter.

Several studies document that US women are interested in OTC access to OCs. In a 2011 national survey, 62% of women reported that they were strongly or somewhat in favor of OCs being available OTC; 33% of women currently using a less effective birth control method (like condoms alone) and 28% of women using no method said they were very or somewhat likely to start using the pill if it were available OTC. Uninsured and privately insured women, younger women, and current pill users were more interested in OTC access; women of all races and ethnicity were equally interested [6].

Additional research suggests that requiring a prescription from a health care provider for hormonal contraception does not necessarily improve reproductive health outcomes, and that women are able to screen themselves for contraindications. A 2008 study among Latinas in Texas found that women can accurately use a checklist to assess whether they have contraindications to pill use [7]. However, more data that closely approximate a real-world OTC environment are needed to determine if current or potential users of oral contraception in the United States can accurately self-screen for contraindications.

Giving women greater control over their birth control choices with easier access to safe, effective options may lead to higher rates of initiation and continuation and fewer gaps in contraceptive use. This could in turn lead to a decrease in the rates of unintended pregnancy. However, some women might not benefit from a switch or may find access more difficult in an OTC environment, especially in the absence of insurance coverage for OTC products. The experience with moving EC OTC shows that cost, especially when there is limited competition in the marketplace, remains a barrier for some.

Members of the working group recognize that individual women will experience different benefits and risks of an OTC product based on factors such as underlying health status, race, income, education and literacy, immigration status, and access to culturally competent reproductive and preventive health services. As such, the working group is committed to evaluating the risks and benefits of a switch from multiple perspectives.

To maximize the benefit and minimize the risk for every woman, the working group will carry out several activities, including: conducting original research; engaging in public education and discussion; building consensus on key issues, particularly with those who will be most affected by a switch; and, where appropriate, influencing the drug development and regulatory process. We will initiate dialogue with health professions associations as well as organizations representing diverse groups of women and create informational materials appropriate for different audiences. Additionally, we will liaise with health insurance experts and Medicaid advocates to expand public and private insurance coverage of OTC contraceptives without requiring a prescription. If an OTC switch for an OC does take place, we also plan to monitor the impact on women’s health, access, and out-of-pocket expenditures. We recognize our goal cannot be achieved without creating conditions that will promote good outcomes in an OTC environment. We will therefore support policies that:

Expand coverage of OTC birth control without a prescription in all public and private insurance plans.
Ensure adolescents have full access to OTC contraceptives.
Ensure pharmacies and retail outlets have proactive measures in place to guarantee an individual’s religious or moral beliefs do not interfere with people’s access to contraception.
Train health educators, including pharmacy staff, to answer consumers’ questions about OTC OCs.
Expand access to the full range of contraceptive methods, especially for people who have a harder time obtaining the contraception they want and need.

While the focus of our work is domestic, we recognize that regulatory changes in the United States could have ramifications in other countries. We plan to disseminate our results internationally and hope to adapt our materials for people outside of the United States who could benefit from easier access to birth control pills. Additionally, we can learn from the experiences of other countries where contraception is more demedicalized than in the United States, and will look to international experience to inform our efforts.

The working group is open to clinicians, researchers, and advocates with a direct interest in the issue. Employees of the pharmaceutical industry and FDA are welcome to join the group informally as individuals, although we will involve them in our activities at our discretion. The working group’s activities are guided by a steering committee composed of individuals from the research, clinical, and advocacy communities. The working group has been funded by private foundation and government research grants and in-kind contributions of group members. The working group does not accept any contributions from manufacturers of birth control methods to support its meetings or advocacy and education efforts; we may accept funding from pharmaceutical companies for research activities, but all such funding will be clearly declared.

This statement was approved by the working group Steering Committee on June 23, 2016, and may be revised and updated as data and real world experience on this topic accumulates.
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References

1. Cohen SA. Abortion and women of color: The bigger picture. Guttmacher Policy Review. Summer 2008; 11(3): 2-12.
2. Sonfield A, Tapales A, Jones RK, Finer LB. Impact of the federal contraceptive coverage guarantee on out-of-pocket payments for contraceptives: 2014 update. Contraception. 2015; 91(1): 44-8.
3. Parsons J, Adams C, Aziz N, Holmes J, Jawad R, Whittlesea C. Evaluation of a community pharmacy delivered oral contraception service. The Journal of Family Planning and Reproductive Health Care. 2013; 39(2): 97-101.
4. Stuart JE, Secura GM, Zhao Q, Pittman ME, Peipert JF. Factors associated with 12-month discontinuation among contraceptive pill, patch, and ring users. Obstetrics & Gynecology. 2013; 121(2 Pt 1): 330-6.
5. Reproductive Health Technologies Project. Women’s health advocates celebrate FDA decision to remove restrictions on generic emergency contraception. 2014 [cited 2016 June 23]; Available from: http://www.rhtp.org/documents/RHTPPressRelease-FDADecisiontoRemoveRestrictionsonGenericEC.pdf
6. Grossman D, Grindlay K, Li R, Potter JE, Trussell J, Blanchard K. Interest in over-the-counter access to oral contraceptives among women in the United States. Contraception. 2013; 88(4): 544-52.
7. Grossman D, Fernandez L, Hopkins K, Amastae J, Garcia SG, Potter JE. Accuracy of self-screening for contraindications to combined oral contraceptive use. Obstetrics & Gynecology. 2008; 112(3): 572-8.

Sign-ons:

Abortion Care Network
Adolescent Health Initiative
Advancing New Standards in Reproductive Health (ANSIRH)
Advocates for Youth
All-Options
American Academy of Nursing
American Academy of PAs
American Academy of Pediatrics
American Civil Liberties Union
American College of Clinical Pharmacy Women’s Health Practice and Research Network
American College of Nurse-Midwives
American College of Obstetricians and Gynecologists
American Nurses Association
American Sexual Health Association
Association of Physician Assistants in Obstetrics & Gynecology
Association of Reproductive Health Professionals (ARHP) (closed)
Association of Women’s Health, Obstetric, and Neonatal Nurses (AWHONN)
Black Women for Reproductive Justice (closed)
Black Women for Wellness
Black Women’s Health Imperative
Bold Futures
California Latinas for Reproductive Justice
California Women’s Law Center
Catholics for Choice
Center for Biological Diversity
Center for Reproductive Rights
CHOICES. Memphis Center for Reproductive Health
Colorado Organization for Latina Opportunity and Reproductive Rights (COLOR)
Contraceptive Access Initiative (CAI)
DKT International
Doctors for America
EngenderHealth
Essential Access Health
ETR
EverThrive Illinois
Feminist Majority Foundation
FHI 360
Forward Together
Girls Inc.
Grandmothers for Reproductive Rights GRR!
Guttmacher Institute
Gynuity Health Projects
Healthy Teen Network
Ibis Reproductive Health
If/When/How: Lawyering for Reproductive Justice
Illinois Caucus for Adolescent Health
Illinois Contraceptive Access Now (ICAN)
In Our Own Voice: National Black Women’s Reproductive Justice Agenda
Indigenous Women Rising
Ipas
Jacob’s Institute of Women’s Health
Jane’s Due Process
John Snow, Inc.
Latino Commission on AIDS
Legal Voice
Medical Students for Choice
Michigan Organization on Adolescent Sexual Health
NARAL Pro-Choice America
NARAL Pro-Choice Maryland Fund
National Abortion Federation
National Asian Pacific American Women’s Forum
National Association of Nurse Practitioners in Women’s Health (NPWH)
National Association of Pediatric Nurse Practitioners
National Center for Lesbian Rights
National Council of Jewish Women
National Family Planning & Reproductive Health Association
National Health Law Program
National Hispanic Medical Association
National Institute for Reproductive Health
National Latina Institute for Reproductive Health
National LGBTQ Task Force
National Organization for Women
National Partnership for Women & Families
National Women’s Health Network
National Women’s Law Center
Native American Community Board (NACB)
New Jersey Health Care Quality Institute
North American Society for Pediatric and Adolescent Gynecology
Northwest Health Law Associates
Nurses for Sexual and Reproductive Health
NY Birth Control Access Project
Pathfinder International
Physicians for Reproductive Health
Planned Parenthood Federation of America
Population Connection
Population Council
Positive Women’s Network – USA
Power to Decide
Prosalud Interamericana Foundation
Religious Coalition for Reproductive Choice
Reproaction
Reproductive Health Access Project
Reproductive Health Technologies Project (closed)
Rez Condom Tour
Rhia Ventures
Sexual Health and Reproductive Equity Program
SIECUS: Sex Ed for Social Change
SisterLove
SisterReach
SisterSong
Society for Adolescent Health and Medicine
Society of Family Planning
Society of General Internal Medicine
Society of General Internal Medicine – Women and Commission
SPARK Reproductive Justice Now!, Inc.
Training in Early Abortion for Comprehensive Healthcare
Upstream USA
URGE
Venture Strategies for Health and Development (closed)
Wisconsin Alliance for Women’s Health
Women’s Health Research Team
Women with a Vision
Woodhull Freedom Foundation
WREN

Katie Adamek, MPH, Researcher, Mathematica
Eli Y. Adashi, MD, MS, CPE, FACOG, Brown University
Elisabeth Aubeny, Medical Gynaecologist, President of French Association for Contraception
Sandra Azancot, BS
Lynn Borgatta, MD, MPH, Department of OB/GYN, Boston Medical Center
Anne Burke, MD, MPH, FACOG, Johns Hopkins University
Reia Chapman, MSW, LISW-CP, LCSW, Center for Family & Maternal Wellness
Kelly Cleland, MPA, MPH, American Society for Emergency Contraception and Princeton University
Sima Michaels Dembo, SMD Health Consulting
Marian Evans, MD, MPH, CRA, Assistant Professor, Southern CT State University
Beth Fredrick, Johns Hopkins Bloomberg School of Public Health
Jenn French, Attorney
Richard A. Grossman, MD, MPH
Edith Guilbert, MD, MSc, Medical Adviser, National Institute of Public Health of Quebec, Canada; Clinical Professor, Department of OB/GYN, Laval University, Quebec, Canada
Cynthia C. Harper, PhD, Bixby Center for Global Reproductive Health, UCSF
Kathleen Hill-Besinque, PharmD, FASHP, USC School of Pharmacy
David Howard, MD, PhD, Department of OB/GYN, University of Missouri-Kansas City
Julie Komarow, MD, Sound Family Medicine, Washington State Medical Association
Ali Kubba, FRCOG, FFSRH
Marjorie Macieira, M.A., Macieira Consulting, LLC
Shawn Malarcher
Jennifer McIntosh, PharmD, MHS
Susan Milstein, PhD, MCHES, Milstein Health Consulting
Tony Ogburn, MD, Department of OB/GYN, University of New Mexico
Heather Paladine, MD, MEd, FAAFP, Assistant Professor of Medicine, Center for Family and Community Medicine Columbia University Medical Center
Rachel Perry, MD, MPH, Assistant Professor of Obstetrics and Gynecology, University of California, Irvine
Kathryn Phillips, PhD, UCSF
Joseph E. Potter, PhD, Population Research Center, University of Texas at Austin
Heather Prescott, PhD, Department of History at Central Connecticut State University
Sally Rafie, PharmD
Francisco T. Rivas, Esq.
Eleanor Bimla Schwarz, MD, MS, Associate Professor of Medicine, Epidemiology, Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh
Kunal Sindhu
Summer Starling, DrPH MPH, Founder & Principal, Starling Consulting Group, Inc.
Lisa M. Stone, Executive Director, Legal Voice
James Trussell, PhD, Office of Population Research, Princeton University
Becky Twamley, RPh
Ellen Wiebe, MD, Medical Director, Willow Women’s Clinic; Clinical Professor, University of BC
Lisa Wynn, PhD, Department of Anthropology, Macquarie University
Matthew Young, Harvard Medical School

If you or your organization is interested in signing on to this statement of purpose, please contact us!