HRA Pharma, a Perrigo company, has submitted an application to the FDA seeking approval for the country’s first-ever over-the-counter (OTC) birth control pill.
As President Joe Biden mulls the declaration of a public health emergency following the U.S. Supreme Court’s decision to overturn Roe v. Wade, HRA Pharma, a Perrigo company, has submitted an application to the U.S. Food and Drug Administration seeking approval for the country’s first-ever over the counter (OTC) birth control pill.
The application requests a prescription to OTC switch for Opill, which HRA Pharma acquired from Pfizer in 2014. Opill is a progestin-only daily birth control pill that prevents pregnancy by thickening the mucus in the cervix, preventing sperm from entering the uterus. As with all applications of this nature to the FDA, a decision is expected within ten months.
“This historic application marks a groundbreaking moment in contraceptive access and reproductive equity,” Frédérique Welgryn, chief of strategic operations and innovation officer at HRA Pharma, said in a press release. “More than 60 years ago, prescription birth control pills in the U.S. empowered women to plan if and when they want to get pregnant. Moving a safe and effective prescription birth control pill to OTC will help even more women and people access contraception without facing unnecessary barriers.”
Normally, an application request to switch from prescription to OTC wouldn’t garner much attention. However, this application arrives swiftly after the Supreme Court voted to overturn Roe v. Wade, ending the federally protected right to abortion. On Sunday, Biden stated that he is considering declaring a public health emergency to free up federal resources to promote abortion access. Reportedly, White House officials have questioned the legality and effectiveness of this action, leading others to think of different ways to increase access to reproductive health care.
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This is not the first time that HRA Pharma has discussed OTC birth control with the FDA. As reported by The New York Times, since 2016, both HRA and Cadence Health have held discussions with the regulatory agency to bring OTC birth control to the market. Cadence Health is currently in the process of seeking approval for its oral contraceptive Zena with the company reporting that it is currently testing new OTC labels and packaging with consumers. Cadence has faced setbacks with the FDA, including a halt on its actual-use trial in which the FDA asked for repeated tests on OTC use and for the company to reconsider adding new warnings on its drug safety label.
Adverse events are a primary concern for those hesitant to advocate for OTC birth control. Birth control pills have decades of evidence to support their efficacy and safety, but it is true that the medication can increase the risk of heart attack, stroke and blood clots and interact with certain medications. Opposers to OTC birth control believe that unsupervised use of the medication could cause serious side effects.
However, many are quick to point out that pregnancy itself can cause the same risks. Additionally, many people take birth control to manage other health conditions that are equally risk-posing such as extremely heavy menstrual cycles and endometriosis. OTC birth control has also received overwhelming support from the Pro-Choice Caucus, which recently penned a letter to FDA Commissioner Robert M. Califf urging that the FDA approach applications to OTC birth control in a swift manner and defend against political interference during review.
Beyond OTC birth control, activists are also calling for OTC access to abortion medication, specifically Mifeprex produced by Danco Laboratories. The FDA stated that the company would have to present data showing Mifeprex was safe for use in miscarriage. The company reportedly did not have any plans to provide such data.
