Opill: FDA Panel Gives Green Light to Over-the-Counter Birth Control

Last week, a panel of Food and Drug Administration (FDA) advisors unanimously recommended Opill for approval as an over-the-counter birth control option, citing expanded access to contraception and reduced unintended pregnancies as key advantages of OTC sales. Reproductive experts and advocacy groups, including Free the Pill, pointed out that young people, minorities, and those who have issues obtaining a prescription for their contraceptive needs would particularly benefit from OTC access to birth control. Lupe M. Rodríguez, executive director of the National Latina Institute for Reproductive Justice, stated that "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." Approval for OTC oral contraception 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).

According to ACOG, increasing access to birth control through over-the-counter oral contraception is critical for avoiding unintended pregnancies and controlling reproductive futures since the fall of Roe v. Wade. In the U.S., Opill would be the first birth control pill available without a prescription if approved. Opill, a progestin-only birth control pill, comprises 0.075 mg norgestrel and has been used by millions of people since its 1973 FDA approval. Advocates for approving Opill for OTC use, including Daniel Grossman, MD, director of Advancing New Standards in Reproductive Health, have stated that Opill is both effective in preventing pregnancy and safe to use. Additionally, many other countries already offer OTC birth control like Opill.

Progestin-only birth control pills such as Opill do not contain estrogen, which can have potential side effects like blood clots, and they may be a better option for individuals who are unable to take estrogen-containing birth control, according to Molly McBride, MD, a board-certified gynecologist with Elite Gynecology. Unintended pregnancy is a public health issue in the United States, with more than a third of pregnancies estimated to be unintended. Experts estimate that unintended pregnancies could be reduced by over 80% by making OTC birth control more accessible, particularly for teenagers, young adults, and minorities who typically have limited access to birth control and may rely on less effective methods for pregnancy prevention.

Jill Purdie, MD, board-certified OB-GYN and medical director at Pediatrix Medical Group, highlights that having their own options for birth control and reducing the reliance on their partner utilizing a condom would be a huge benefit for people. Individuals without health insurance or teenagers who do not have access to a provider without a parent's knowledge would also be able to access reliable birth control, potentially avoiding unintended pregnancy. Furthermore, removing the prescription requirement would improve access to a contraceptive that is more effective at preventing pregnancy than all current methods available OTC.

“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.”

The exact timeframe for when the FDA will make a decision following the recent vote has not been released. But they have a lot of evidence to consider before making a decision.

“The FDA is tasked with ensuring that medications available in the U.S. meet rigorous safety and efficacy standards,” explained 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 will be considering 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 would still be 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 explained.

The FDA also will likely 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.”