FDA approves first over-the-counter birth control pill in the US

On July 13, the Food and Drug Administration (FDA) approved an over-the-counter birth control pill that can be sold without a prescription for the first time in the United States. The pill is sold under the brand name Opill and will be the most effective birth control method available without a prescription. Oral contraceptives are more effective in preventing pregnancy than barrier methods such as condoms, according to the Cleveland Clinic.

[Related: Over-the-counter birth control pills could change reproductive care in the US.]

Nonprescription availability of the drug, generic name norgestrel, should reduce barriers to access by allowing individuals to obtain oral contraception without seeing a health care provider first, according to the FDA. Roughly half of the 6.1 million annual pregnancies in the US are unintended, which have been linked to negative maternal and perinatal outcomes.

“Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States,” director of the FDA’s Center for Drug Evaluation and Research Patrizia Cavazzoni said in a statement today. “When used as directed, daily oral contraception is safe and is expected to be more effective than currently available non prescription contraceptive methods in preventing unintended pregnancy.”

Opill’s manufacturer Perrigo Company said that it will most likely be available in stores and online retailers in early 2024, but did not specify how much the medication would cost. However, Perrigo’s global vice president for women’s health Frédérique Welgryn, called the move a “groundbreaking expansion for women’s health in the US,” and said that the company was committed to making Opill “accessible and affordable to women and people of all ages.”

Opill is a once-daily single hormone birth control pill. CREDIT: Perrigo via PR Newswire.

Perrigo submitted several years of research to the FDA that demonstrates that women can understand and follow the instructions for using the pill. Today’s approval also came despite some concerns from FDA scientists on whether individuals with some underlying medical conditions would understand that they shouldn’t take Opill.

Like with many birth control pills, Opill should be taken at the same time every day for effectiveness. The most common side effects include irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps or bloating.

Since the Supreme Court’s decision in Dobbs v. Jackson Women’s Health overturned the federal right to abortion in June 2022, accessibility to contraception has become an increasingly urgent issue. Even before that decision, the move to develop an over-the-counter birth control pill received support from groups such as the American Medical Association and the American College of Obstetricians and Gynecologists.

[Related: What we know about hormonal birth control and breast cancer risk.]

“We’re thrilled by the FDA’s historic decision to approve Opill as the first ever over-the-counter birth control pill,” executive director of the National Latina Institute for Reproductive Justice and Free the Pill coalition steering committee member Lupe M. Rodríguez said in a statement. “Over-the-counter access to birth control will greatly reduce the barriers that prevent Latinas/xs from getting the care they need, including barriers due to transportation, cost, language, and documentation. 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. Now we must ensure that this safe and effective birth control pill is affordable and covered by insurance.”

Today’s FDA action only applies to Opill which is in an older class of contraceptives that are sometimes called minipills. These contain a single synthetic hormone and typically have fewer side effects than combination hormone pills.

Some women’s health advocates hope that this major decision will signal more over-the-counter birth control options and even for abortion pills in the future.