FDA Approves 1st Over-the-Counter Birth Control Pill Amid Falling US Birth Rates

The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

U.S. officials have approved the first over-the-counter birth control pill, which will let people purchase contraceptive drugs from the same store aisles as Tylenol and aspirin as the birth rate in the United States continues to drop.

On Thursday, the Food and Drug Administration (FDA) said that it cleared Perrigo’s once-a-day Opill to be sold without a prescription. It’s the first such drug that can be used over-the-counter, and there are no age restrictions.

Hormone-based pills, the most common form of birth control in the United States, have been used by tens of millions of women since the 1960s, with all of them requiring a prescription—until Thursday.

“Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States,” Dr. Patrizia Cavazzoni, the head of the FDA’s Center for Drug Evaluation and Research, said in a statement Wednesday. “When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy.”

The pill’s manufacturer, Perrigo, called the FDA action a “milestone” as well as a “giant leap for women’s empowerment” in a statement posted online after the agency’s approval. The firm said that it would make it “accessible and affordable to women and people of all ages.”

“Today’s approval is a groundbreaking expansion for women’s health in the U.S., and a significant milestone towards addressing a key unmet need for contraceptive access,” Frederique Welgryn, a Perrigo official, said in the statement.

But Ireland-based Perrigo did not announce a price. Over-the-counter medicines are generally much cheaper than prescriptions, but they typically aren’t covered by insurance.

Forcing insurers to cover over-the-counter birth control would require a regulatory change by the federal government, which left-wing groups are urging the Biden administration to implement.

Elaborating, the FDA said that it approved the pill, in part, because it may reduce the number of “unintended pregnancies.”

“Nonprescription availability of Opill may reduce barriers to access by allowing individuals to obtain an oral contraceptive without the need to first see a health care provider. Almost half of the 6.1 million pregnancies in the U.S. each year are unintended,“ the agency said. ”Unintended pregnancies have been linked to negative maternal and perinatal outcomes, including reduced likelihood of receiving early prenatal care and increased risk of preterm delivery, with associated adverse neonatal, developmental and child health outcomes.”

The drug’s availability “may help reduce the number of unintended pregnancies and their potential negative impacts,” the FDA added in the statement.

Declining US Birth Rates

Over the year, there have been numerous studies in the United States and other countries suggesting that increased access to contraception such as birth-control pills can lead to a decline in fertility and birth rates. A 2021 study published in JAMA Network found that birth rates among women with employer-given health insurance dropped significantly after the Affordable Care Act, or Obamacare, eliminated the need for copays and other patient fees for birth control.

“The study results suggest that free, reliable birth control reduced unintended pregnancies, the authors note. About half of all pregnancies in the population at large are unintended, and birth rates from unintended pregnancies are much higher among low-income women than other income groups,” says a UCLA writeup of the JAMA study.

U.S. birth rates have plummeted over the past five decades or so, according to federal officials in an early 2023 report that surveyed tens of thousands of people. “Between 1976 and 2018, the mean number of children ever born per woman declined, from three children to two,” the report (pdf) said.

According to the report, they noted that better access to contraception, more women going into the workforce, “relationship instability,” and changing family values may have contributed to the trend. The relatively high cost of child rearing was also a factor, they found.

The latest U.S. Centers for Disease Control and Prevention (CDC) data suggests that the percentage of American women who have ever given birth to a child has declined once again, continuing a decades-long trend.

“A lower percentage of women aged 15 to 44 in 2015–2019 had ever had a biological child (52.1 percent) compared with women aged 15 to 44 in 2011–2015 (54.9 percent),” said a Jan. 10, 2023, report that was issued by the CDC’s National Center for Health Statistics. It also noted that declines were also seen in men becoming fathers across the United States. Between 2015 and 2019, 39.7 percent of males aged 15 to 44 fathered a child, compared to 43.8 percent during the 2011–2015 period.

As Italy made free oral contraception available for women earlier this year, meanwhile, several pro-birth groups said that the measure would create a drop in births.

“The resources used could have been allocated to alleviate the serious conditions of families with disabled children who need very expensive drugs that are not provided free of charge,” the leader of the Family Day association, Massimo Gandolfini, said, according to local media. And a non-profit association Pro Vita & Famiglia, or Pro Life & Family, described the free birth control pill measure as “serious and dangerous.”

The Associated Press contributed to this report.