FDA Approval

FDA Approves First Over-the-Counter Birth Control Pill

Increased Access to Safe and Effective Contraception

On Thursday, the United States Food and Drug Administration (FDA) made a monumental decision by approving the first daily oral contraceptive for over-the-counter (OTC) use. This breakthrough medication, called Opill, was initially approved in 1973, but until now, users needed a prescription to access it.

The Importance of Over-the-Counter Birth Control

Melissa Simon, a clinical gynecology researcher at Northwestern University, emphasizes the significance of OTC birth control. “This is a huge step forward,” she says. “OTC birth control is available in over 100 countries, so we’ve been lagging behind in providing safe and effective methods like this oral contraceptive pill to individuals who are trying to prevent pregnancy.”

The Efficacy of Birth Control Pills

Birth control pills are one of the most popular forms of contraception. In 2018, about 20% of contraceptive users between the ages of 15 and 49 were taking a pill. Oral birth control pills are up to 99% effective at preventing pregnancy when taken daily. Opill, specifically, has been found to be 93% effective, according to NBC News.

Types of Birth Control Pills

There are two main types of birth control pills: combination pills and minipills. Combination pills, the most common, contain the hormones estrogen and progestin. Minipills, including Opill, contain only progestin.

Addressing Concerns

The FDA committee did have some concerns about Opill, such as its potential side effects, which may include vaginal bleeding, headaches, cramps, or dizziness. Additionally, people with a history of breast cancer should not take the pill, as it could promote tumor growth. However, the committee ultimately decided that individuals can make the choice whether using the pill is right for them.

Expanding Access to Contraception

Organizations such as the American Academy of Pediatrics and the American Medical Association (AMA) have applauded the FDA decision, saying it will help provide millions of patients with broader access to safe and effective reproductive health care.

“At a time when reproductive health care services are becoming increasingly limited and reproductive health clinics are closing in several states, improving access to oral contraceptives is critically important,” says Jesse M. Ehrenfeld, president of the AMA. “We hope this is just the first of several to be approved, and we urge the FDA to consider applications from the full range of available oral contraceptives for over-the-counter access.”

Addressing Unintended Pregnancies

The U.S. has a higher rate of unintended pregnancies than many other developed countries. About 45% of the six million pregnancies in the U.S. in 2011 were not intentional. Increased access to the full range of contraceptive methods and correct and consistent use of contraceptives can help decrease unintended pregnancies.

Contraceptive Deserts and Access Barriers

Power to Decide, a nonprofit campaign to prevent unplanned pregnancy, estimates that more than 19 million reproductive-age women live in contraceptive deserts, or areas where the number of health centers offering a full range of methods cannot meet the demands of the women eligible for publicly funded contraception.

Even in areas with health centers, people with low income, teens, and people of color have reported greater challenges in getting and picking up prescriptions, including paying for a doctor’s visit and getting time off work.

The Availability and Cost of Opill

After Opill becomes available without a prescription—which the maker estimates will happen in early 2024—those seeking the minipill will be able to purchase it at grocery and convenience stores across the country, and access will come with no age restrictions.

However, questions remain about the pill’s cost, which Perrigo will release later this year. Birth control pills can cost about $15 to $30 per month without insurance coverage. While over-the-counter medications are generally less expensive, they are also not usually covered by insurance.

Empowering Individuals

“If this is implemented correctly, expanding access to birth control will allow our communities the freedom to make meaningful decisions about our lives and futures,” says Lupe M. Rodríguez, executive director at the National Latina Institute for Reproductive Justice. “Now, we must ensure that this safe and effective birth control pill is affordable and covered by insurance.”