A big deal, and a long time coming.
The Food and Drug Administration approved the first ever over-the-counter birth control pill in the United States Thursday, a huge advancement in contraceptive accessibility amid an ever more restrictive abortion landscape.
“Approval of this progestin-only oral contraceptive pill provides an option for consumers to purchase oral contraceptive medicine without a prescription at drug stores, convenience stores and grocery stores, as well as online,” the agency said in a statement.
It also pointed out that “almost half of the 6.1 million pregnancies in the U.S. each year are unintended” — a statistic the approval of over-the-counter Opill may improve.
Final approval seemed likely after an advisory panel unanimously recommended that the pill become available without a prescription in May.
Hearings earlier this spring were replete with questions about climbing rates of maternal mortality and the adverse outcomes associated with unintended pregnancy. But the abortion landscape, critical background to any conversation about accessibility of contraception, was all but absent.
See here for some background. The Associated Press adds some details.
Ireland-based Perrigo did not announce a price. Over-the-counter medicines are generally much cheaper than prescriptions, but they aren’t covered by insurance.
Many common medications have made the switch to non-prescription status in recent decades, including drugs for pain, heartburn and allergies.
Perrigo submitted years of research to FDA to show that women could understand and follow instructions for using the pill. Thursday’s approval came despite some concerns by FDA scientists about the company’s results, including whether women with certain underlying medical conditions would understand they shouldn’t take the drug.
FDA’s action only applies to Opill. It’s in an older class of contraceptives, sometimes called minipills, 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 more 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 mifepristone. The studies in Perrigo’s FDA application began years before the Supreme Court’s reversal of Roe 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, health advocates and medical professionals to ease access to birth control. The American Medical Association and the leading professional society for obstetricians and gynecologists backed Opill’s application for over-the-counter status.
The main thing about this is that it should make the pill easier for more women to get, which in turn should help prevent more unwanted pregnancies, no small consideration in this day and age. That said, we know that the same forced-birth zealots also hate birth control and will both exploit the legal system and harass pharmacies to limit the impact of this decision. There’s always a backlash, so be ready for one here as well. The 19th has more.