What Is Opill? FDA Approves First Over-the-Counter Birth Control

Opill, the daily oral contraceptive, received FDA approval for over-the-counter use today.

In May, Opill received a unanimous recommendation from a panel of Food and Drug Administration (FDA) advisors, encouraging the FDA to approve it as an OTC birth control option.

At the top of their list of reasons, approving Opill for OTC sales would expand access to contraception and reduce unintended pregnancies, particularly for young people, minorities, and those who have difficulty dealing with the challenges involved in getting a prescription for their contraceptive needs, reproductive experts and advocacy groups like Free the Pill noted.

“Over-the-counter access to birth control is widely supported by Latinas/xs and would greatly reduce the barriers that prevent our communities from getting the care they need,” Lupe M. Rodríguez, executive director of the National Latina Institute for Reproductive Justice told Health.

Making OTC oral contraception available to the general public is also supported by major medical organizations including the American College of Obstetricians and Gynecologists (ACOG), the American Medical Association (AMA), and the American Academy of Family Physicians (AAFP).

ACOG indicates that since the fall of Roe v. Wade, increasing access to birth control through over-the-counter oral contraception is critical so that people can not only control their own reproductive futures but also avoid unintended pregnancies.

Opill is the first birth control pill available without a prescription in the U.S.

What Is Opill?

Opill is a progestin-only birth control pill that, according to the manufacturer, consists of 0.075 mg norgestrel. This pill, which was approved by the FDA in 1973, has been used by millions of people in the U.S. since it was first approved.

Advocates for approving the pill for over-the-counter use, like Daniel Grossman, MD, director of Advancing New Standards in Reproductive Health and a member of the Department of Obstetrics, Gynecology, and Reproductive Sciences at UCSF, indicate that Opill is not only proven effective in preventing pregnancy but is also safe to use.

“As a physician, birth control pills are one of the safest medications I can prescribe to my patients, and removing the medically unnecessary prescription requirement will mean that more people can get care without barriers,” Dr. Grossman explained. “From a public health and equity perspective, this is a win-win.”

What’s more, many other countries already offer OTC birth control like Opill, noted Sarah McBane, PharmD, BCPS, FCCP, FCPhA, FSCHP, APh, founding associate dean of pharmacy education at the UC Irvine School of Pharmacy and Pharmaceutical Sciences.

Progestin-only birth control pills like Opill also are appealing because they do not contain estrogen, which can have potential side effects such as blood clots, said Molly McBride, MD, a board-certified gynecologist with Elite Gynecology. “They may also be a better option for people who are unable to take estrogen-containing birth control.”

Why Experts Believe OTC Birth Control Is Important

Unintended pregnancy is a significant public health issue in the United States, with researchers estimating that more than a third of pregnancies are unintended.

By making OTC birth control more accessible, experts estimate that unintended pregnancies could be reduced by more than 80%. This benefit is particularly important for teens, young adults, and minorities who typically have limited access to birth control and often rely on less effective methods for pregnancy prevention.

Being able to make their own decisions about when to start birth control also is a huge benefit, noted Jill Purdie, MD, board-certified OB-GYN and medical director at Pediatrix Medical Group. “It would also allow [people] to have an option for birth control that is not dependent on their partner utilizing a condom.”

Additionally, people without health insurance—or teenagers who do not have access to a provider without a parent’s knowledge—would be able to access reliable birth control and potentially avoid unintended pregnancy, Dr. Purdie added.

This is a huge benefit for people who have ever tried to get a prescription and were met with challenges. In fact, one study indicates that nearly one-third of U.S. women have experienced difficulties getting a prescription (or refill) for a contraceptive pill, patch, or ring.

Removing the prescription requirement would not only improve access, but it also would make available a contraceptive that is more effective at preventing pregnancy than all current methods available OTC. Plus, it would provide an OTC option for people that cannot take birth control containing estrogen.

“Some people cannot take estrogen because of a past history of blood clots, because they have a higher risk of blood clots, or because they must take medications that interact with estrogen,” noted Dr. McBane. “Other people are not able to tolerate estrogen due to side effects, particularly nausea and vomiting. Many of these individuals do very well on progestin-only contraceptives.”

Considerations Regarding the Approval of Opill

The FDA had a lot of evidence to consider before making the decision to approve Opill.

“The FDA is tasked with ensuring that medications available in the U.S. meet rigorous safety and efficacy standards,” said Dr. McBane. “Over-the-counter medications must be especially safe because they can be used without any supervision from a healthcare practitioner.”

More specifically, the FDA must consider the likelihood of whether or not people will use the medication as directed. There also has been some concern that people might not recognize that progestin-only pills could potentially be less effective in people who are obese.

“[Research suggests] obesity can affect the effectiveness of birth control pills because it can impact the way that the medication is metabolized in the body,” Dr. McBride said. Some people also maintain that those who are overweight or obese may need a higher dose of the medication to achieve the same level of effectiveness, she added.

But, experts stress that Opill is still more effective than no birth control and should not be withheld. What’s more, current evidence continues to support progestin-only daily contraceptives, like Opill, as safe and effective regardless of BMI (body mass index), Dr. McBane said.

The FDA also had to consider the pill’s side effects—although the risk is relatively low for progestin-only pills, she noted. While progestin-only contraceptives are very safe, there is still a risk of side effects just like with any other medication.

“The most likely side effects include irregular bleeding, headache, nausea, and breast tenderness, though,” Dr. McBane concluded. “These are the same side effects someone might experience with any progestin-only contraceptive. Remember that a pharmacist or physician can provide advice on both OTC and prescription contraceptives at any time.”