(Bloomberg) -- A French drugmaker wants to make its contraceptive the first of its kind for sale in the US, an over-the-counter birth-control product that would make bring the country up to speed with more than 100 others that make such pills accessible without a prescription. 

HRA Pharma, a unit of generic drug maker Perrigo Co., asked US regulators Monday to approve Opill for over-the-counter sales.  Known as a “minipill” because it includes only the hormone progestin and no additional estrogen, it has been cleared by the Food and Drug Administration for prescription sales for almost five decades. 

Pills are the most popular form of contraception among women between the ages of 15 and 49, according to the Centers for Disease Control and Prevention; a recent study indicated that 14% of women rely on them for birth control. The application carries special weight, coming just weeks after the Supreme Court decision that dismantled abortion rights by reversing Roe v. Wade. The Biden administration issued an executive order last week intended to preserve access to the procedure, which is already facing further restrictions in states hostile to abortion rights.

“We are in a health-care crisis in this country and there is no better time than now to get behind this because it addresses a real-time need,” said Monica Simpson, the executive director of the reproductive-justice group SisterSong and a steering committee member of the Free the Pill advocacy coalition.

Unnecessary Barriers

 Over 100 countries, including most of those in Asia and Latin America, allow some forms of birth-control pills to be sold over the counter, the advocacy group Free the Pill notes, and the UK last July approved two progestin-only pills for over-the-counter pharmacy sales. This makes the US something of an outlier with regards to access.

“Moving a safe and effective prescription birth-control pill to OTC will help even more women and people access contraception without facing unnecessary barriers,” Frederique Welgryn, HRA Pharma’s chief strategic operations and innovation officer, said in a statement.

Lack of access to birth control can have serious economic and social consequences for women and families. A 2020 brief from the US Joint Economic Committee notes that birth control access is linked to higher enrollment in college, as well as law, business and medical school. A 2012 paper from the National Bureau of Economic Research attributes one-third of the wage gains women have made since the 1960s to birth control, as pregnancy, parental leave and child care all impact women’s ability to contribute to the work force.

Birth control and abortion are both “parts of the overall tools that people need to be able to exercise their reproductive freedom,” said Megan Kavanaugh, a senior research scientist with the Guttmacher Institute. “We need to make sure we have all of these options for healthcare that people need to achieve their full respective lives.”

Obtaining prescriptions can be a key obstacle to accessing birth-control pills, advocates say.  People who received the drugs without prescriptions were more likely to continue taking them after nine months than those who got them at a doctor’s direction, according to a 2011 survey.

A study by the advocacy group Ibis Reproductive Health and the University of California, San Francisco, found that nearly one in three women who had tried to obtain hormonal birth control had encountered barriers in doing so. Uninsured women and Spanish speakers were more likely than their insured and English-speaking counterparts to experience barriers. A separate study published by researchers at Columbia University Medical Center found that limited access was a contributing barrier to teens’ birth control use.

Chilling Effect

Both progestin-only birth-control pills and combination pills that include estrogen are shown to be safe and effective, said Daniel Grossman, director of its Advancing New Standards for Reproductive Health research program at the University of California, San Francisco, although minipills are more widely used in Europe than the US. Doctors typically screen patients by asking whether they have conditions that may be exacerbated by the drugs, such as breast cancer, or are taking medications whose breakdown may be sped up by the pills. However, patients can easily answer those questions on their own, Grossman said.

The US regulatory process and politics have delayed clearing over-the-counter birth-control pills, Guttmacher’s Kavanaugh said. The same forces stood in the way of the adoption of the emergency contraceptive Plan B, she said. Health advocates and contraception opponents fought for more than a decade over nonprescription status for Plan B, a battle that finally ended in 2013 when the product moved out from behind the counter. 

The experience with Plan B “had a chilling effect on what people thought would be possible in terms of moving oral birth-control pills over the counter,” Kavanaugh said.

Affordability of an over-the-counter pill is also important to access, said Kelly Blanchard, the president of Ibis Reproductive Health, which seeks to advance sexual and reproductive autonomy and health. While many health plans cover the full costs of prescription birth-control pills, the group’s research shows that people are willing to pay from about $10 to $20 a month for an over-the-counter pill, she said. 

“Our coalition is committed very squarely to an afford a birth-control pill over the counter that's affordable, covered by insurance without needing a prescription, and available to people of all ages,” Blanchard said. 

HRA is “committed to making Opill affordable for all those who need it,” Welgryn said in an email, and the company is working to establish a financial assistance program.

Mandated Report

The company estimates it would take the FDA around 10 months to process its application, meaning that OTC birth control would be available in early 2023 if approved. The timing also coincides with an  increased interest in Plan B, intrauterine devices and other long-acting reversible contraception, as well as  medical procedures like vasectomies. Biden’s executive order includes a mandate that the Department of Health and Human Services submit a report regarding efforts to protect abortion pills, contraception and emergency medical care for pregnant people. 

Iffath Abbasi Hoskins, president of the American College of Obstetricians and Gynecologists, praised HRA’s application, saying it aligns with the group’s support for over-the-counter birth control options.

“By increasing access to birth control through over-the-counter oral contraception, we have an opportunity to empower more people to control their own reproductive futures, including avoiding pregnancy,” Abbasi Hoskins said in a statement. “In addition to private conversations with their trusted obstetrician-gynecologist or through new routes of access like over-the-counter access, it is critical that all people have reproductive autonomy without burdens, barriers, or restrictions.” 

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