HRA Pharma is seeking FDA approval for the first birth control pill that people could buy without a prescription in the U.S.
Since the 1960s, millions of Americans have used hormone-based pills to prevent pregnancy, making daily contraceptive pills one of the most common forms of birth control in the country, according to the U.S. Centers for Disease Control and Prevention (CDC).
In June, the Supreme Court overturned Roe v. Wade, the landmark case that federally protected the right to an abortion. In the opinion, Justice Clarence Thomas wrote that the Court should also reconsider other rulings, including Griswold v. Connecticut, which protects the liberty of married couples to buy and use contraceptives without government restriction. In many countries outside of the U.S., birth control pills are available over the counter, but recent online searches show (here, here and here) that many people are wondering if they can get daily contraceptive pills in the U.S. without a prescription.
Is an over-the-counter daily birth control pill currently available in the U.S.?
No, an over-the-counter daily birth control pill is not currently available in the U.S.
On July 11, pharmaceutical company HRA Pharma submitted an application to the FDA to switch Opill, a progestin-only daily birth control pill, from prescription to over the counter. If approved, it would be the first daily birth control pill available without a prescription in the U.S.
An over-the-counter (OTC) daily birth control pill is not currently available in the United States. According to the U.S. Food and Drug Administration (FDA), all OTC medications must meet FDA quality, effectiveness and safety standards prior to receiving the agency’s approval.
The FDA lists available birth control options in the U.S on its website. Combination oral contraceptives (pills that contain two hormones, estrogen and progestin, to stop the ovaries from releasing eggs; commonly known as “the pill”) and the “mini pill,” a progestin-only oral contraceptive, both need a prescription from a healthcare provider, according to the FDA.
Other short-acting hormonal birth control methods, including the patch and the vaginal contraceptive ring, also need prescriptions. Hormone-based birth control pills have always required a prescription in the U.S., usually so health care providers can screen for conditions that raise the risk of rare, but dangerous, blood clots.
The “morning-after” emergency contraceptive pill, also known as Plan B, is available in the U.S. over the counter without a prescription. Plan B is not a daily contraceptive but instead, a single-dose pill meant to be taken after sexual activity.
RELATED: Claim that Plan B emergency contraceptive pill has a weight limit needs context
On July 11, HRA Pharma, a pharmaceutical company based in France, submitted its application for a prescription to OTC switch for Opill, a progestin-only daily birth control pill (also known as a mini pill or non-estrogen pill) to the FDA. Opill has been used to prevent pregnancy in the U.S. since it was approved by the FDA in 1973, HRA Pharma said in a press release. If approved, it would be the first daily birth control pill available OTC without a prescription in the U.S.
“Nearly one-third of adult U.S. women who have ever tried to obtain a prescription or refill for contraceptive pill, patch, or ring reported difficulties doing so,” HRA Pharma said, citing a 2016 study. “Removing the prescription requirement with Opill would improve access to a contraceptive method that is well tolerated and notably more effective at preventing pregnancy than all current methods available OTC.”
Most birth control pills contain progestin plus estrogen, which can help make periods lighter and more regular, but estrogen also accounts for most of the blood clot risk associated with oral contraceptives. The FDA’s labeling warns against their use in certain women already at risk for heart problems, such as those who smoke and are over 35.
Progestin-only pills, like Opill, are generally recommended for women who can’t take the more popular combination pills due to health issues. OTC birth control pill advocates were particularly interested in Opill because they say it’s likely to raise fewer safety concerns.
RELATED: No, health data from most period-tracking apps is not protected under HIPAA
Over 100 countries currently provide birth control pills OTC without a prescription, according to a 2012 study conducted by Ibis Reproductive Health, a global research and advocacy organization. Ibis has led a coalition-driven effort, known as “Free the Pill,” to bring the birth control pill over the counter in the U.S. for nearly two decades.
In a press release, Ibis said the organization and its coalition partners conducted critical research and built consensus on the need for an over-the-counter birth control pill for a decade. Ibis says it partnered with HRA Pharma in 2016 to conduct the research needed to submit its application to the FDA.
“Ibis Reproductive Health celebrates this important milestone and looks forward to continuing to work with coalition members to ensure that future OTC birth control pills are affordable, fully covered by insurance, and accessible to people of all ages in the United States,” Ibis wrote.
Cadence Health, another company that has been working on an OTC birth control pill for several years, says it has plans to submit its own application to the FDA for Zena, an oral combined contraceptive pill. In early 2021, the FDA placed a hold on a clinical study by Cadence Health, telling the company to conduct additional blood pressure checks of trial participants. Cadence Health told VERIFY it is “actively working to overcome this regulatory hurdle by developing an easy-to-use technology interface for our OTC product.”
“We have conducted more than 30 studies with more than 3,000 women simply to determine that women are able to understand the contraindications and follow the instructions, as there are some women who should not take the birth control pill,” Cadence Health said. “We were ready to begin the final step, the Actual Use Trial, when the FDA placed the study on hold. We are now working diligently to overcome this regulatory hurdle. Of note, there is more than 25 years of safety data on this particular pill.”
RELATED: VERIFY Fact Sheet: Where abortion is legal, and where it is not
Several major medical associations, including the American College of Obstetricians and Gynecologists, the American Medical Association, and the American Academy of Family Physicians, all support moving birth control pills over the counter. In March, more than 50 members of Congress sent a letter to FDA Commissioner Robert M. Califf, M.D., expressing their support for OTC birth control pills.
“We urge FDA to review applications for over-the-counter birth control pills without delay and based solely on the data and defend against political interference during the review processes. The health and well-being of people capable of pregnancy across America is at stake,” the congressmembers wrote.
The FDA is required to hold a public meeting to evaluate HRA Pharma’s application before making a decision. Executives at HRA expect a decision in the first half of 2023.
VERIFY reached out to the FDA for comment but did not hear back by the time of publication.
The Associated Press contributed to this report.
More from VERIFY: No, the Supreme Court’s decision to overturn Roe v. Wade does not ban birth control