A French pharmaceutical company, HRA Pharma, has submitted an application to the FDA for approval of the first over-the-counter (OTC) oral contraceptive in the US.1,2 Although the company has been working with the FDA since 2015 to clear the application, the actual submission is timely in light of the US Supreme Court's decision to overturn Roe v. Wade. Rumblings about a possible attack on rights to contraception in general adds importance to this move by HRA Pharma.
Abortion has always been a heated, emotional topic in this country, sparking fierce debate, and leading to protests and often violent behaviors in the midst of advocacy on both prolife and prochoice sides.
Support for OTC use
Opill is a minipill that contains only the hormone progestin. HRA Pharma has successfully marketed an OTC minipill in the United Kingdom since 2021 under the brand name Hana(R). A decision from the FDA is expected sometime in the next 10 months. The American Medical Association, the American College of Obstetricians and Gynecologists, and the American Academy of Family Physicians have voiced support for OTC oral contraceptives because they are considered safe, and women can be trusted to assess their own risk and make informed decisions about taking them. Many organizations have been working for decades to remove barriers to contraception and reproductive healthcare services, such as Planned Parenthood and the Free the Pill coalition, which seeks reproductive justice and "...more equitable access to safe, effective, and affordable birth control to people of all ages, backgrounds, and identities..." in the US.3
The minipill
Combination oral contraceptive pills contain estrogen and progestin. The progestin-only minipill has been available in the US since 1973. Progestin alters cervical mucus (thickens) and the endometrium (thins), reducing the chance of implantation of a fertilized egg. One disadvantage of progestin-only pills is they must be taken daily at the same time. The minipill is a contraceptive option suitable for women who are breastfeeding, have certain health problems such as a history of blood clots or migraine headaches, have poorly controlled high BP, are over 35 years of age, or simply have concerns about taking estrogen. In 2011, Plan B, an emergency contraceptive with only the progestin levonorgestrel, was approved by the FDA for access without a prescription with some restrictions, preventing many unplanned pregnancies. No method of birth control is 100% effective, and all hormonal preparations involve a risk for adverse reactions.
Health equity
The ever-present and ongoing problem of access to reproductive health services and the right to make medical decisions about one's personal health-which includes when to seek pregnancy-will not disappear for women. Healthcare disparities and inequities entrenched in the US health system are well documented. Even with OTC oral contraceptives, there will still be challenges and barriers. Will Opill be affordable? Will insurers cover the OTC minipill but require a prescription (necessitating a medical visit) for enrolled members? Will the pill be available in all pharmacies in every state? Will providers, pharmacies, and pharmacists create administrative barriers to access? What will messaging to women state? Women's health issues and reproductive rights across the US deserve attention from the APRN profession. Health equity is a goal that can only be achieved by addressing social justice issues through advocacy and action.
Jamesetta A. Newland, PhD, FNP-BC, FAANP, DPNAP, FAAN
EDITOR-IN-CHIEF [email protected]
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