FDA Approves First Over-the-Counter Birth Control Pill

Experts say the decision will increase access to safe and effective contraceptives for millions of Americans

Opill logo
Opill was first approved by the FDA about 50 years ago, but until now, users needed a prescription to access it. Perrigo Company

The United States Food and Drug Administration (FDA) approved the first daily oral contraceptive for over-the-counter use on Thursday. The medication, called Opill, was initially approved in 1973, but its manufacturer, Perrigo’s HRA Pharma, applied for the drug to be available without a prescription last year. 

“This is a monumental decision,” Melissa Simon, a clinical gynecology researcher at Northwestern University, tells Berkeley Lovelace Jr. of NBC News. “OTC birth control is available in over 100 countries, so we’ve been behind in availing safe, effective methods such as this oral contraceptive pill to individuals who are trying to avoid pregnancy.”

The pill is one of the most popular forms of birth control—in 2018, about 20 percent of contraceptive users ages 15 to 49 were taking a pill. Oral birth control pills are up to 99 percent effective at preventing pregnancy when taken daily, and Opill was found to be 93 percent effective, per NBC News. They come in two main varieties, according to Mayo Clinic: combination birth control pills and the minipill. Combination pills, the most common, contain the hormones estrogen and progestin. Minipills, including Opill, contain only progestin.

Organizations such as the American Academy of Pediatrics and the American Medical Association (AMA) have applauded the FDA decision, saying the move will help provide millions of patients gain “broader access to safe and effective reproductive health care,” per a statement from the AMA. 

“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 to ensure patients can effectively limit unintended pregnancies and manage family planning,” Jesse M. Ehrenfeld, president of the AMA, says in the statement. “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.”

The approval comes about a year after the Supreme Court overturned Roe v. Wade, ending the constitutional right to an abortion. Following a separate opinion from Justice Clarence Thomas in which he wrote the court “should reconsider” past rulings on contraception access, same-sex relationships and same-sex marriage, some worried that access to contraceptives could be overturned next.

The U.S. has a higher rate of unintended pregnancies than many other developed countries—about 45 percent of the six million pregnancies in the U.S. in 2011 were not intentional, per the Guttmacher Institute, a research and policy organization focused on reproductive health. Increased access to the full range of contraceptive methods and correct and consistent use of contraceptives can help decrease unintended pregnancies

Power to Decide, a nonprofit campaign to prevent unplanned pregnancy, estimates 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. And about 1.2 million of those women live in a county without a single center that provides the full range of contraceptive methods. 

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, reports Matthew Perrone for the Associated Press.

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.

But questions remain about the pill’s cost, which Perrigo will release later this year, per the AP. 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. 

“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,” Lupe M. Rodríguez, executive director at the National Latina Institute for Reproductive Justice, says in a statement. “Now, we must ensure that this safe and effective birth control pill is affordable and covered by insurance.”

The FDA committee did have some concerns about the pill, 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—and FDA scientists had worried some consumers wouldn’t be aware of that. But the committee decided that individuals can choose whether using the pill is right for them.

“There are no good scientific reasons to keep them from being as accessible as possible,” Sarah Prager, an obstetrics and gynecology specialist at the University of Washington, says to NBC News.

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