Professor serves as scientific advisor for new over-the-counter birth control pill approval
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On the 63rd anniversary of the approval of the first daily birth control pill in the U.S., the U.S. Food and Drug Administration advisory committee met in May to review an application for the first over-the-counter daily birth control pill available to consumers. On July 13, the FDA announced the approval of Opill, signaling a historic moment in birth control access, particularly for adolescents.
SPH’s Julie Maslowsky, PhD, associate professor of community health sciences and core faculty with the UIC Center of Excellence in Maternal and Child Health, served as an independent scientific advisor to HRA Pharma, a Perrigo company, as it sought federal approval for the pill.
“This has been a long time coming, as more than 100 other countries already offer this,” Maslowsky said. “The public consensus and the medical and scientific consensus are all very much in favor of this.”
Maslowsky brought a public health lens to the regulatory process, including deep expertise on the sexual and reproductive health needs of adolescents. This was a particularly crucial area for FDA approval, given that the agency has the authority to place age restrictions on medications. Maslowsky brought together existing literature on developmental science, adolescent decision-making and maturity, brain development, health disparities, needs for access to contraception and populations experiencing high rates of unintended pregnancy.
Overall, the accumulated evidence points to the value of and need for an over-the-counter birth control pill, particularly for adolescents. This population often faces barriers to access to prescribed contraception due to confidentiality issues, as physicians may be required to notify parents of an adolescent seeking contraception. Young people may face real and perceived stigma in discussing this topic with a clinical provider or family.
The convenience of an over-the-counter pill also reduces barriers for adolescents, who may experience limited transportation options and scheduling conflicts due to requirements to attend school. For people of all ages with limited healthcare access, often due to immigration status or socioeconomic barriers, an over-the-counter option should significantly improve access.
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We know adolescents have high rates of unintended pregnancy, and we know adolescents want to use contraception, for the most part. Often, it’s systemic, structural barriers or confidentiality issues that prevent that.Associate Professor of Community Health Sciences|
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Maslowsky acknowledges the FDA’s decision may generate some controversy. However, she notes the open public comment period showed vast public support for the FDA’s approval. Major medical organizations include the American College of Obstetricians and Gynecologists, the American Medical Association and the Society for Adolescent Health and Medicine all endorsed the FDA’s decision.
This was Maslowsky’s first experience working with industry on a policy and regulatory issue. She said the experience was a unique opportunity to translate scientific evidence into policy and practice.
“The question of whether adolescents are able to make effective, independent decisions about sexual and reproductive health is a scientific question that can be answered with existing scientific evidence. The answer is clearly yes.” Maslowsky said. “Being able to present this evidence to support something that was medically, scientifically, and ethically a very clear need, was really rewarding.”
From her lens as a researcher, Maslowsky says she wants to examine how the access of an over-the-counter pill affects adolescents’ contraception choices, in particular which groups will benefit from increased access. She notes in the post-Dobbs landscape, adolescents are reporting increased fear of unintended pregnancies, especially in the wake of increasing restrictions on access to sexual and reproductive healthcare. She says this FDA approval represents a safe and effective option that can improve equity among populations that struggle with healthcare access and are most at risk.