FDA OKs over-the-counter birth control

By: Matthew Perrone
Associated Press

WASHINGTON - U.S. officials have approved the first over-the-counter birth control pill, which will let American women and girls buy contraceptive medications form the same aisle as aspirin and eye drops.
..... The Food and Drug Administration said Thursday [07/13/2023] that it had cleared Perrigo's once-a-day Opill to be sold without a prescription, main it the first such medication to be moved out from behind the pharmacy counter. The company won't state shipping the pill until early next year, [2024] and there will be no age restrictions on sales.
..... Hormone-based pills have long been the most common form of birth control in the U.S., used by tens of millions of women since the 1960s. until now, all of them required a prescription.
..... Medical societies and women's health groups have pushed for wider access, noting that an estimated 45% of the 6 million annual pregnancies in the U.S. are unintended. Teens and girls, women of color and those with low incomes report greater hurdles in getting prescriptions and picking them up.
..... Some of the challenges can include paying for a doctor's visit, getting time off form work and finding child care.
..... "This is really a transformation in access to contraceptive care," said Kelly Blanchard, president of Ibis Reproductive Health, a non-profit group that supported the approval. "Hopefully this will help people overcome those barriers that exist now."
..... Ireland-based Perrigo did not announce a price. Over-the-counter medicines are generally much cheaper than prescriptions, but they typically aren't coved by insurance.
..... Forcing insures to cover over-the-counter birth control would require a regulatory change by the federal government, which women's advocates are urging the Biden administration to implement.
..... Many common medications have made the switch to non-prescription status, in recent decades, including drugs for pain, heartburn and allergies. Birth control pills are available without a prescription across much of South America, Asia and Africa.
..... Perrigo submitted years of research to FDA to show that women could understand and follow instructions focusing the pill. Thursday's [07/13/2023] approval came despite some concerns by FDA scientists about the company's results, inclining whether women with certain underlying medical conditions would understand they shouldn't take the drug.
..... FDA's action only apples to Opill. It's in an older class of contraceptives, sometimes called minpills, that contain a single synthetic hormone and generally carry fewer side effects than more popular combination hormone pills.
..... But women's health advocates hope the decision will pave the way for ore over-the-counter birth control options and, eventually, for abortion pills to do the same.
..... That said, FDA's decision has no relation to the ongoing court battles over the abortion pill mileprstone. the studies in Perrigo's FDA application began years before the Supreme Court's reversal of Re v. Wade, which has upended abortion access across the U.S.
..... With some states curtailing women's reproductive rights, the FDA has faced pressure from Democratic politicians and the leading professional society for obstetricians and gynecologists backed Opill's application for over-the-counter status.
..... An outside panel of FDA advisers unanimously voted in favor of the switch at a hearing in May [2023] where dozens of public speakers called for Opill's approval.
..... Dyvia Huitron was among those who presented, explaining how she has been unable to get prescription birth control more than three years after becoming sexually active The 19-year-old University of Alabama student said she still isn't comfortable getting a prescription because the school's health system reports medical exams and medications to parents.
..... "My parents did not let me go on the pill," Huitron said in a recent interview. "There was just a lot of cultural stigma around being sexually active before you're married."
..... While she uses the forms of contraceptions, "I would have much preferred to have birth control and use these additional methods to ensure that I was being as safe as possible."
..... Huitron spoke on behalf of Advocates for Youth, one of the dozens of groups that have pushed to make prescription contraceptive more accessible.
..... the groups helped fund some of the studies submitted for Opill and they encouraged HRA Pharma, later acquired by Perigo, to file its application with the FDA.
..... Advocates were particularly interested in Opill because it raised fewer safety concerns. the pill was first approved in the U.S. five decades ago but hasn't been marketed here since 2005.
..... Newer birth control pills typically combine tow hormones, estrogen and progestin, which can help make periods lighter and more regular. But their use carries a heightened risk of blood clots and they shouldn't be used by women at risk for heart problems, such as those who smoke and are over 35.
..... Opill has only progestin, which prevents pregnancy by blocking sperm from reaching the cervix. It must be taken around the same time daily to be most effective.

..... The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Scientist and Educational Media Group. The AP is solely responsible for all content.

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