Good news: FDA approves daily birth control pill

The U.S. Food and Drug Administration announced on July 13, 2023, it has approved the country’s first daily birth control pill that can be used without a prescription, a move that reproductive health advocates celebrated after more than 20 years of advocating for an over-the-counter option.

The contraceptive, called Opill, is a progestin-only oral pill that could soon become available in drug stores, convenience stores and grocery stores, as well as online, without requiring a visit to a health care provider.

Michelle Trupiano, Missouri Family Health Council executive director, said July 13 also included distressing news for many Missourians’ health care access

“At the same time the FDA approved the first-ever, over-the-counter birth control pill, Congress proposed eliminating Title X, a federal safety-net program thousands of Missourians rely on for affordable birth control and related preventive care,” she said in a release.

“Defunding Title X will hinder critical access to family planning services at a time when reproductive healthcare is already in deep crisis.

She called the FDA approval of Opill “a promising first step for increasing access,” but added that further investment in the safety net is needed to ensure everyone can obtain contraception that’s right for them.

“The availability of over-the-counter birth control removes just one barrier – it does not eliminate the many additional and often insurmountable barriers Missourians face. More needs to be done, including state-level policy change, to ensure equitable access to affordable sexual and reproductive health services,” according to Trupiano.

Services Offered by Title X include contraception counseling and supplies, pregnancy screening and counseling, preconception care, reproductive life planning, and basic infertility services

Also covered are wellness exams, clinical breast and cervical cancer screenings, and sexually transmitted infection (STI) and HIV prevention, screenings, treatment, and immunizations. 

Opill’s manufacturer, Perrigo, anticipates the pill will be on sale in major retail stores across the country and online by early 2024. The retail price was not disclosed, and the firm plans to work to list Opill as an option with private insurance and Medicaid.

Reproductive-focused organizations including the American College of Obstetricians and Gynecologists, celebrated the announcement, as did the American Medical Association [AMA].

Dr. Jesse M. Ehrenfeld, AMA president, said in a statement that it should be the first step of approval for a variety of oral contraceptive options for over-the-counter use.

“It is important that patients have options when choosing which type of birth control works best for them. We hope this is just the first of several to be approved,” Ehrenfeld said

 “We must continue to remove barriers to affordable care for those in underserved, high-poverty, and rural communities. We know barriers to oral contraceptives can lead to inconsistent or discontinued use.”

According to research from the Guttmacher Institute, nearly half of the 6.1 million pregnancies in the U.S. in 2011 were unintended, and 18% of those pregnancies were considered unwanted. Further evidence has determined unintended pregnancy is significantly associated with higher incidences of depression during pregnancy and postpartum, along with higher rates of preterm birth and low infant birth weights.

Fourteen states, including Missouri, have near-total bans on abortion. Iowa could soon join Georgia with a gestational ban at six weeks, before many people realize they are pregnant.

Indiana’s abortion ban, which applies to all stages of pregnancy with exceptions for rape, incest, fetal anomalies, and the life of the pregnant person, is expected to take effect Aug. 1.

“Opill over-the-counter paves the way for improved access by removing barriers for the people who struggle to access contraception most, particularly people working to make ends meet, people of color, young people, and those who live in rural areas,” said Dr. Stephanie Sober, global lead of medical affairs for Perrigo

“For some, the ability to secure insurance, find a provider, make an appointment, and then obtain childcare and access reliable transportation, all can create an insurmountable obstacle to obtaining contraception. Being able to pick it up at a pharmacy knocks down those obstacles, and it’s truly game changing.”

The FDA said Opill should not be used by those who currently have or have ever had breast cancer, and those who have had any other form of cancer should ask a doctor before use. It should not be used with any other hormonal birth control product, including other oral pills, patches or injections, vaginal rings, or intrauterine devices.