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Friday, Jul 14 2023

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First Birth Control Pill Authorized For Over-The-Counter Sale In US

The FDA authorized Thursday that HRA Pharma's Opill, a daily progestin-only oral contraceptive, can be purchased without a prescription, making the birth control pill easier to obtain.

In a highly anticipated move, the Food and Drug Administration on Thursday approved the first over-the-counter birth control pill, a decision that could transform the way contraception is delivered in the United States. For the first time, people will now be able to readily purchase birth control online and at pharmacies, convenience stores, and grocery stores without a prescription, a requirement that has been seen as a hurdle to greater access to contraception. Called the Opill, it is expected to become available in the first quarter of 2024, but the pricing has not yet been disclosed by Perrigo, the company that manufactures the pill. (Silverman, 7/13)

The Food and Drug Administration on Thursday approved HRA Pharma鈥檚 progestin-only birth control medication Opill, making it the nation鈥檚 first over-the-counter birth control pill. 鈥淭oday鈥檚 approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States,鈥 said Patrizia Cavazzoni, director of the FDA Center for Drug Evaluation and Research. (Clason, 7/13)

Perrigo submitted years of research to the FDA to show that women could understand and follow instructions for using the pill. Thursday鈥檚 approval came despite some concerns by FDA scientists about the company鈥檚 results, including whether women with certain underlying medical conditions would understand that they shouldn鈥檛 take the drug. The FDA鈥檚 action only applies to Opill. It鈥檚 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. (Perrone, 7/13)

鈥淭his is historic and transformative for reproductive rights without having to go to a physician, which presents a barrier to many people,鈥 according to Julie Maslowsky, an associate professor at the University of Illinois Chicago School of Public Health. She was a scientific consultant for HRA Pharma, a subsidiary of Perrigo that submitted the application to the FDA for approval. (Malhi, 7/13)

Despite the news, there are concerns over the drug's cost 鈥

While the Food and Drug Administration's decision to approve over-the-counter birth control pills could make contraception more accessible in places where it's hard to find a prescriber, the still-unknown cost could be a major hurdle. Health insurance plans are not required to cover birth control methods obtained without a prescription, meaning that consumers who take HRA Pharma's Opill, once it's available over-the-counter next year, will likely pay out-of-pocket. (Gonzalez, 7/14)

In other birth control developments 鈥

Local family planning advocates are trying to increase access to birth control medications like Plan B in light of evolving abortion restrictions in Iowa. The Iowa Legislature passed a bill banning most abortions around six weeks of gestation late Tuesday night, with exceptions for the life of the pregnant person or for rape and incest if they're reported to law enforcement within a certain time span. (Ta, 7/13)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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