FDA Makes History by Approving First Over-the-Counter Birth Control

When Opill becomes available in pharmacies in early 2024, it will be the first nonprescription daily birth control pill in the United States.

Photo of different packs of birth control pills
The FDA’s approval of over-the-counter Opill is an important step forward in access. Rewire News Group illustration

The Food and Drug Administration made history today when it approved Opill, a progestin-only birth control pill, for over-the-counter use. When Opill becomes available in pharmacies in early 2024, it will be the first nonprescription daily birth control pill in the United States.

Opill’s OTC approval is a major victory for advocates and researchers who have pushed for this change for decades. It also catches the United States up to most of the rest of the world, where contraceptive pills have long been more accessible. Experts agree: It’s about time.

There’s no question that the FDA’s approval of the first birth control pill 63 years ago changed the course of many of our lives. But for too many people—especially low-income people, people of color, and young people—a full range of contraceptive options remains out of reach.

The FDA’s approval of OTC Opill is an important step forward in access, at a time when the conservative movement is ratcheting up its attacks on birth control. It’s also a major milestone in the long history of contraceptive innovation. What step forward might we see next?

Ancient history
For as long as there have been humans, there has been birth control. People in ancient societies—from Crete to Egypt to China—used condoms made from materials like linen and silk.

People in New Guinea even developed a female condom. Around the world, people always knew that certain plants could be used for contraception or abortion.

The modern contraceptive era begins with the invention of rubber condoms and diaphragms. Sponges also become a popular method of contraception.

Congress passes the Comstock Act, which bans the mailing of “obscene” material, including devices and information related to birth control. Activists work around the law by sneaking contraceptives into shipping containers with other products, among other risky maneuvers.

Two gynecologists, Kyusaku Ogino and Hermann Knaus, figure out that ovulation happens roughly in the middle of the menstrual cycle and introduce cycle tracking, or the “rhythm method,” as a form of contraception.

Animal experiments find that high doses of the hormone progesterone stop ovulation.

Late 1940s to ’50s
Chemist Carl Djerassi, known as the “father of the pill,” figures out how to make synthetic progesterone. Planned Parenthood founder Margaret Sanger closely follows these scientific developments and personally funds birth control pill research led by biologist Gregory Pincus.

Sanger’s friend Katharine Dexter McCormick—one of the first female graduates of the Massachusetts Institute of Technology and heir to a massive fortune—begins funding birth control pill research. Over the next few years, she gives around $2 million to the cause.

Catholic gynecologist John Rock, also a friend of Sanger’s, conducts the first human birth control pill trials on 50 patients in Boston.

Federal and state Comstock laws make conducting larger trials in the mainland U.S. too difficult, so Rock and Pincus take their research to Puerto Rico. Their experimental pill contains far higher hormone dose than today’s pills, which means more risks and side effects.

Though the Puerto Rico trials confirm that the pill works, Rock and Pincus dismiss local doctors’ concerns about side effects. Over 200 women are involved in these trials, and are not made aware of all the potential risks. One woman dies. Similar trials are conducted in Mexico and Haiti.

The FDA approves Enovid, the first oral contraceptive pill.

In Griswold v. Connecticut, the Supreme Court legalizes contraception for married couples.

13 million people worldwide are using the pill.

The Supreme Court case Eisenstadt v. Baird legalizes contraception for single people.

Scientists confirm that much lower hormone doses are safer and just as effective, so newer and better pills come onto the market.

1990s to 2000s
Other hormonal delivery methods like patches, rings, gels, and injections become available, expanding options further.

The FDA approves the first hormonal emergency contraceptive pills. Scientists had known since the early 1970s that higher doses of existing birth control pills could prevent pregnancy if taken after sexual activity, but this was an uncommon off-label use until the late 90s.

The FDA approves the first over-the-counter (OTC) emergency contraceptive, Plan B, for people 18 and older.

The FDA approves OTC Plan B for all ages.

Pharmaceutical company Perrigo submits an application to the FDA to bring a progestin-only daily pill, Opill, over the counter.

May 2023
FDA advisory committees hold a public hearing on the Opill application and vote unanimously to recommend approval.

July 2023
The FDA approves over-the-counter Opill.