Company seeks FDA approval for OTC birth control pill

HRA Pharma is seeking FDA approval for the first birth control pill people in the US can buy without a prescription

Since the 1960s, millions of Americans have used hormone-based pills to prevent pregnancy, making the daily birth control pill one of the most common forms of birth control in the country, according to the US Centers for Disease Control and Prevention (CDC).

In June, the Supreme Court upheld Roe v. Wade, the landmark case that protected abortion rights at the federal level. In the opinion, Justice Clarence Thomas wrote that the Court should consider other judgments, including Griswold v. Connecticut, which protects the freedom of married couples to buy and use contraceptives without government restrictions. Birth control pills are available over the counter in many countries outside the US, but recent online research shows (here, here, and here) that many people are wondering if they can get daily birth control pills in the US without a prescription.


Is an over-the-counter daily birth control pill currently available in the US?



That's wrong.

No, an over-the-counter daily birth control pill is not currently available in the United States

On July 11, pharmaceutical company HRA Pharma filed an application with the FDA to switch Opill, a progestin-only pill used for daily birth control, from a prescription to an over-the-counter (OTC) pill. If approved, it would be the first over-the-counter daily birth control pill in the United States


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 drugs must meet FDA quality, efficacy, and safety standards before receiving agency approval.

The FDA lists birth control options available in the United States on its website. Combined 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 require a prescription by a healthcare provider, according to the FDA.

Other short-acting hormonal birth control methods, including the patch and vaginal birth control ring, also require a prescription. Hormone-based birth control pills have always required a prescription in the US, usually so healthcare providers can screen for conditions that increase the risk of rare but dangerous blood clots.

The morning-after emergency contraceptive pill, also known as Plan B, is available over the counter in the United States. Plan B isn’t a daily contraceptive, but a two-dose regimen to be taken after sexual activity.

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On July 11, HRA Pharma, a pharmaceutical company based in France, submitted its application to the FDA for an OTC Switch prescription for Opill, a progestin-only daily birth control pill (also known as the minipill or non-estrogen pill). . Opill has been used to prevent pregnancy in the United States since it was approved by the FDA in 1973, HRA Pharma said in a press release. If approved, it would be the first over-the-counter birth control pill in the United States

“Nearly one-third of U.S. adult women who have ever attempted to obtain a prescription or refill for birth control pills, patches or rings reported difficulty doing so,” HRA Pharma said, citing a 2016 study. “Removing the prescription requirement for Opill would increase access to a birth control method that is well tolerated and significantly more effective at preventing pregnancy than any currently available OTC method.”

Most birth control pills contain progestin plus estrogen, which can help make periods lighter and more regular, but estrogen is also responsible for most of the risk of blood clots associated with oral contraceptives. The FDA label warns against its use in certain women who are already at risk for heart problems, such as: B. Smokers and over 35-year-olds.

Progestogen-only pills like Opill are generally recommended for women who cannot take the more popular combination pills for health reasons. Over-the-counter birth control pill advocates have been particularly interested in Opill because they say it’s likely to pose fewer safety concerns.

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Over 100 countries currently offer over-the-counter birth control pills, according to a 2012 study by Ibis Reproductive Health, a global research and advocacy organization. Ibis has led a coalition-driven initiative called “Free the Pill” to get the birth control pill over the counter in the United States for nearly two decades.

In a press release, Ibis said the organization and its coalition partners had conducted critical research and reached a 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 is celebrating this important milestone and looks forward to continuing to work with coalition members to ensure future OTC birth control pills are affordable, fully insured and accessible to people of all ages in the United States,” Ibis wrote.

Cadence Health, another company that has been working on an OTC contraceptive pill for several years, plans to submit its own application to the FDA for Zena, an oral combination contraceptive pill. In early 2021, the FDA halted a Cadence Health clinical trial, requiring the company to conduct additional blood pressure checks on study participants. Cadence Health informed VERIFY that it is “actively working to overcome this regulatory hurdle by developing a user-friendly technology interface for our OTC product.”

“We have conducted more than 30 studies involving more than 3,000 women simply to determine if women are able to understand the contraindications and follow the instructions given that there are some women who should not take birth control pills,” said Cadence Health. “We were ready to begin the final step, the actual use trial, when the FDA put the study on hold. We are now working flat out to overcome this regulatory hurdle. What is remarkable is that there is more than 25 years of safety data on this particular pill.”

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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 the over-the-counter sale of birth control pills. In March, more than 50 members of Congress sent a letter to FDA Commissioner Robert M. Califf, MD, expressing their support for OTC birth control pills.

“We urge the FDA to review applications for over-the-counter birth control pills promptly and solely on the basis of the data and to resist political interference during the review process. The health and welfare of pregnant people across America are at stake,” the congressmen wrote.

The FDA must hold a public meeting to review HRA Pharma’s application before making a decision. HRA executives expect a decision in the first half of 2023.

VERIFY has reached out to the FDA for comment but has received no response at the time of publication.

The Associated Press contributed to this report.

More from VERIFY: No, the Supreme Court decision in Roe v. Repealing Wade doesn’t ban birth control

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