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.
Stat:
FDA Approves First Over-The-Counter Birth Control Pill
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)
Roll Call:
FDA Approves First OTC Birth Control Pill
The Food and Drug Administration on Thursday approved HRA Pharma’s progestin-only birth control medication Opill, making it the nation’s first over-the-counter birth control pill. “Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States,” said Patrizia Cavazzoni, director of the FDA Center for Drug Evaluation and Research. (Clason, 7/13)
AP:
Opill, The First Over-The-Counter Birth Control Pill, Gets FDA Approval
Perrigo submitted years of research to the FDA to show that women could understand and follow instructions for using the pill. Thursday’s approval came despite some concerns by FDA scientists about the company’s results, including whether women with certain underlying medical conditions would understand that they shouldn’t take the drug. The FDA’s action only applies to Opill. It’s 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)
The Washington Post:
What To Know About Opill, The First U.S. Over-The-Counter Birth Control Pill
“This is historic and transformative for reproductive rights without having to go to a physician, which presents a barrier to many people,” 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 —
Axios:
Cost Could Limit Demand For Over-The-Counter Birth Control Pills
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 —
Axios:
Iowa Groups Expand Plan B Access As Abortion Restrictions Loom
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)
