FDA Panel Supports Offering Over The Counter Birth Control

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A U.S. Food and Drug Administration (FDA) advisory panel unanimously endorsed a proposal to make daily birth control pills available over the counter on Wednesday, according to Axios.

The panel’s 17-0 vote comes after two days of committee considerations of HRA Pharma’s Opill. Should the FDA accept the panel’s recommendation, it would be the first time daily birth control pills are available over the counter, Axios reported.

Over the past two days, members of two FDA advisory committees weighed whether patients would be able to understand how to use the pill properly, adhering to specific label instructions such as the need to take the pill at the same time every day, without consulting their physician. Some staff worried that the clinical trial conducted by HRA Pharma showed some consumers had trouble following the instructions, which they noted could result in unintended pregnancy.

Committee members found this should not prevent the pill from being offered over the counter, as patients do not usually receive detailed counselling from their doctors, according to Axios. (RELATED: Kathy Hochul Signs Bill Mandating Abortion Pills Be Available On College Campuses)

The FDA is expected to announce its final decision over the summer.

“I do believe this is a viable option to support access and will support the prevention of unintended and unwanted pregnancies,” said Department of Veterans Affairs researcher Jolie Haun, a panel member who voted in favor of the pill, according to The Associated Press.

Margery Gass, a Cleveland Clinic OB-GYN who was on the panel, said the decision “represents a landmark in our history of women’s health,” according to Axios.

“Unwanted pregnancies can really derail a woman’s life and especially an adolescent’s life, so I’m very pleased that the FDA is seriously considering this and I look forward to it being on the market,” Gass said.

“Today, in a historic step forward for reproductive health, a joint FDA advisory committee voted in favor of moving a progestin-only birth control pill over the counter,” said Free the Pill project director Victoria Nichols in a statement. “Decades of coalition-driven advocacy and research efforts that have centered the voices of those most impacted by barriers to contraception caused by systemic inequities have made this possible.”

HRA Pharma initially announced it had submitted its application to the FDA in July 2022.

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