FDA Receives First Application For Over-The-Counter Birth Control Pill

The Food and Drug Administration (FDA) received its first application for an over-the-counter birth control pill on Monday.

The application comes just weeks after the Supreme Court’s ruling overturned Roe v. Wade, which has some critics concerned about access to contraceptives.

The company behind the application, HRA Pharma, a Perrigo Company, seeks to become the first daily birth control pill available in the U.S. without a prescription.

“This historic application marks a groundbreaking moment in contraceptive access and reproductive equity in the U.S.,” said Frédérique Welgryn, Chief Strategic Operations and Innovation Officer at HRA Pharma, in a statement. “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.”

The American College of Obstetricians and Gynecologists has supported the move to make birth control available over-the-counter in its research, citing barriers to access as a reason for inconsistent or non-use of birth control pills.

According to the National Library of Medicine, 29% of American women who had ever tried to get a prescription for birth control in a 2016 study reported a problem with obtaining a prescription or refills of birth control pills. The percentage was higher among those who were uninsured and Spanish-speaking women in the study.

Despite the push by the company to provide the new over-the-counter option, experts don’t expect any change to occur immediately. Most FDA approvals take more than a year. In addition, if approved, the access would only include HRA Pharm’s Opill pill.

In March, more than 50 members of the House’s Pro-Choice Caucus also sent a letter urging the FDA to review over-the-counter applications for birth control pills right away.

“This is a critical issue for reproductive health, rights, and justice,” the lawmakers wrote in the letter led by Reps. Ayanna Pressley (D-MA), Barbara Lee (D-CA), Diana DeGette (D-CO), and Judy Chu (D-CA). “We ask for your ongoing commitment to advance public health and follow the science and data in all decisions, including the timely review of the oral contraception applications.”

The push for increased options for birth control pills is one of the multiple areas of emphasis following the recent Supreme Court abortion ruling. Despite a push by some on the left that have claimed conservatives will “go after” birth control next, the court’s ruling showed no evidence that this will be the case.

Instead, access to abortion pills has become a discussion for states seeking to further limit abortions following the court’s decision.

Mississippi Governor Tate Reeves (R) said last week that doctors in his state would lose their medical licenses for prescribing abortion pills. Ahead of the Supreme Court’s ruling, Governor John Bel Edwards (D-LA) signed a bill into law that will make mailing abortion pills a crime in his state.

In March, South Dakota Governor Kristi Noem (R) signed a bill into law banning telemedicine abortion in her state.

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