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FDA Approves First Over-The-Counter Birth Control Pill; Set To Hit Market In Early 2024

Signage is seen outside of the Food and Drug Administration headquarters in White Oak, Md. The FDA said July 13 that it cleared a birth control pill to be sold without a prescription. (Photo: OSV News)


WASHINGTON — The Food and Drug Administration approved the first over-the-counter birth control pill July 13, giving the go-ahead for the sale of Opill, by the drug manufacturer Perrigo, without a doctor’s prescription.

The FDA’s decision is only for this pill, not other birth control pills. Opill will be available for sale early next year and will not have an age restriction.

In May, an FDA advisory panel recommended that this product be sold in the U.S. without a doctor’s prescription.

Perigo’s application for FDA approval for over-the-counter sales was submitted years before the Supreme Court’s decision last year upending Roe v. Wade that has brought renewed interest in contraception access with several states now banning abortions.

An initial FDA review of Perrigo’s application to sell Opill without a doctor’s prescription raised some concerns over whether those taking the daily pill would be able to follow the labeling directions correctly and if they would realize when they should not take it without consulting a doctor, particularly if they had certain health concerns, such as breast cancer. But the advisory panel members determined that most women would be able to decide if the pill was appropriate for them to use.

The U.S. Conference of Catholic Bishops joined with the National Catholic Bioethics Center, the Catholic Medical Association, and the National Association of Catholic Nurses urging the FDA advisory panel to oppose the non-prescription availability of Opill without the supervision of a healthcare professional. They cited the potential for numerous negative side effects, including organ failure, cardiovascular disease, or neurological issues among others.

After the panel’s recommendation, Bishop Robert Barron of Winona-Rochester, Minnesota, and chairman of the USCCB’s Committee on Laity, Marriage, Family Life and Youth, said: “Fertility is a gift, not a disease. Contraceptives exist to suppress the healthy functions of human reproduction. The mounting evidence of the many harmful side effects of hormonal contraceptives demonstrates that they are not good medicine.”

Several major medical groups, including the American College of Obstetricians and Gynecologists and the American Medical Association, have supported making the birth control pill available over the counter.

Hormone-based pills, available since the 1960s in the U.S., are the most common form of birth control in this country and have always required a prescription.

Opill, said to be more than 90% effective in preventing pregnancy, was approved by the FDA in 1973. Although most birth control pills contain a combination of progestin and estrogen hormones, Opill only contains progestin and is said to cause fewer side effects and health risks but can also be less effective if not taken around the same time daily.

In a July 13 statement, the FDA said: “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. 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.”

It also said the Opill’s availability “may help reduce the number of unintended pregnancies and their potential negative impacts.”

A remaining question about the drug is its cost and insurance coverage. Perrigo has said it would keep the drug affordable and offer financial assistance to women who qualify.

Under the Affordable Care Act, group health plans and insurance companies are required to cover birth control prescription products. Since insurance companies do not typically cover over-the-counter medications, women’s health groups have been urging the Biden administration to change this.

The U.S. bishops have been vocal against the contraceptive mandate put in place in the Affordable Care Act since this legislation went into effect more than a decade ago. The mandate requires contraceptive and abortion-inducing drugs and devices to be covered by employee health insurance plans with exceptions for religious employers.