As demand for contraceptives spikes in the wake of the Supreme Court overturning Roe v. Wade, a new and crucial avenue for birth control access may be on its way. On July 11, HRA Pharma applied to the Food and Drug Administration (FDA) for approval to sell its progestin-only pills over the counter (OTC), marking the first time a pharmaceutical company has sought permission to do so.
The HRA’s pill won’t be sold over the counter unless the FDA signs off on it – which could be as early as next year – but it’s an intriguing step forward in broadening contraceptive access during a time when these drugs are in high demand.
“This historic application marks a groundbreaking moment in contraceptive access and reproductive equity in the US,” says Frédérique Welgryn, chief strategic operations and innovation officer at HRA Pharma, in a statement from the company. “Moving a safe and effective prescription birth control pill to OTC will help even more women and people access contraception without facing unnecessary barriers.”
The contraceptive under review, Opill, was originally approved for prescription use in the US in 1973, though it hasn’t been marketed in the country for over a decade, according to the Washington Post. Opill is a progestin-only pill (aka mini pill), one of two types of oral birth control available, and which are differentiated by the hormones they contain.
The other type is a combination pill, which contains both estrogen and progestin and is more popular in the US, but also more closely associated with blood clots (though the risk is still very low). People who are already at risk for or who have a history of blood clots are not advised to take combination pills, per the Centers for Disease Control and Prevention, so progestin-only pills are typically offered as an alternative. People who suffer from migraine headaches or who are currently breastfeeding may also be prescribed the mini pill instead of a combination pill, according to the National Library of Medicine.
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In its application for OTC approval, HRA Pharma hopes to show the FDA that people can safely screen themselves for the relatively lower risks of a progestin-only pill.
The company already sells an over-the-counter mini pill in Great Britain, and major medical organizations like the American Medical Association (AMA), the American College of Obstetricians and Gynecologists, and the American Academy of Family Physicians are all in support of having birth control available over the counter. “Providing patients with OTC access to the birth control pill is an easy call from a public health perspective as the health risks of pregnancy vastly outweigh those of oral contraceptive use,” noted AMA Board Member David H. Aizuss, MD, in a statement last month.
While OTC birth control sounds like a straightforward way to improve contraceptive access, there is some concern about a potential price increase. The Affordable Care Act requires health insurance providers to cover prescription birth control, a benefit that would not apply to over-the-counter contraceptives. To address this issue, Welgryn of HRA Pharma says the company will make OTC birth control “very affordable for consumers,” and over 100 Democrats in Congress have signed a bill that would require insurance companies to cover over-the-counter birth control costs, the New York Times reports.
We’re at least a year away from buying birth control pills over the counter, and there are still some hurdles to address before we get there – but HRA Pharma’s application is the next step toward making that a reality, increasing birth control access in a country that’s demanding it.
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