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FDA Approves First Over-the-Counter Birth-Control Pill

I have no comment except to express my profound regret that Spritzler Pharmaceuticals didn't have the foresight to launch this product.

FDA Approves First Over-the-Counter Birth-Control Pill

Perrigo says Opill would be available over the counter by 2024

By Sarah Toy, WSJ

Updated July 13, 2023 1:56 pm ET

The Food and Drug Administration approved the first over-the-counter birth-control pill, Opill, significantly expanding access to contraception among women across the U.S.

The FDA on Thursday followed the advice of expert advisers who recommended in May that the agency grant nonprescription approval to the pill despite questions over some data on its proper use. Medical societies and advocacy groups have called for years for birth control to be available over the counter and it is in countries including South Korea and Greece. The push intensified last year after the Supreme Court eliminated the constitutional right to an abortion, leaving decisions on abortion’s legality to the states.

“This approval is a historic advancement to reproductive healthcare in this country,” said Dana Singiser, co-founder of Contraceptive Access Initiative, a group focused on improving access to oral birth control.

Perrigo, Opill’s manufacturer, said the contraceptive would be available for purchase over the counter by early 2024. The company wouldn’t discuss pricing.

Earlier: Shortly after the Supreme Court overturned Roe v. Wade, an application for an over-the-counter birth control pill was submitted to the FDA. WSJ’s Daniela Hernandez explains the difference between this pill and other contraceptives, and how over-the-counter access could affect reproductive care across the U.S. Photo: Laura Kammermann

Many patients can’t get timely appointments for birth-control prescriptions, doctors said. One-third of oral contraceptive users missed a birth-control dose because they couldn’t get it in time, according to a 2022 survey by KFF, formerly known as the Kaiser Family Foundation. An over-the-counter option will help change that, doctors said.

“Contraception is basic healthcare and shouldn’t be hard to get,” said Dr. Raegan McDonald-Mosley, an obstetrician-gynecologist and chief executive officer of Power to Decide, a nonprofit focused on reproductive health.

Seventeen advisers to the FDA voted unanimously in May to make Opill available over the counter despite concerns the agency raised about data Perrigo submitted with its application, including a study showing that many participants reported taking more pills than they were dispensed. The company said it couldn’t explain the discrepancy.

The agency questioned whether younger people and people with limited literacy could follow the dosing directions and said researchers likely used methods that exaggerated positive results. Perrigo said standards met or exceeded those used in other studies exploring over-the-counter drug adherence.

The experts advising the FDA said that the benefits of making Opill available over the counter exceeded the risks and that its safety had been established for decades. The FDA approved Opill for prescription use in 1973.

Opill contains the hormone progestin, a synthetic version of progesterone. It works by suppressing ovulation and causes changes in the cervix and uterus that decrease the chance of pregnancy. Some other birth-control pills contain both progestin and estrogen. Cadence Health, which makes a combination pill, has said it is talking with the FDA about applying for over-the-counter status.

Nearly half of U.S. pregnancies are unintended, according to the Guttmacher Institute, a group that supports abortion rights and tracks related statistics. Women who have unintended pregnancies are more likely to lose their baby and delay needed care. Their babies are also at higher risk for health problems.

The National Catholic Bioethics Center, U.S. Conference of Catholic Bishops, Catholic Medical Association and National Association of Catholic Nurses wrote last year to the panel advising the FDA on Opill, saying they were strongly opposed to nonprescription availability of Opill. Dr. Tim Millea, chair of the Catholic Medical Association’s healthcare policy committee, said in May that the FDA advisory panel vote to recommend Opill for over-the-counter sale was a disappointment.

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