FDA Receives First Application for Over-the-Counter Birth Control Pill Everyday Health MenuNewslettersSearch Sexual Health News FDA Receives the First Application for an Over-the-Counter Birth Control PillHRA Pharma is seeking approval for its nonprescription drug Opill. By Don RaufJuly 11, 2022Fact-CheckedNonprescription oral contraception is sold in more than 100 countries, but no OTC oral contraceptives have been available in the United States.Canva; Everyday HealthPills for women to prevent pregnancy have been available for more than 60 years in the United States. On Monday, HRA Pharma submitted an application to the U.S. Food and Drug Administration (FDA) for its over-the-counter (OTC) birth control pill. If approved, it would be the first-ever daily birth control pill available OTC, without a prescription, in the United States. “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,” said Frédérique Welgryn, the chief strategic operations and innovation officer at HRA Pharma, in a press release. “Moving a safe and effective prescription birth control pill to OTC will help even more women and people access contraception without facing unnecessary barriers.” A nonprescription birth control pill has received support from major medical organizations, including the American College of Obstetricians and Gynecologists (ACOG), the American Medical Association (AMA), and the American Academy of Family Physicians (AAFP). Currently, nonprescription oral contraception is available in more than 100 countries, and although no OTC oral contraceptives are sold in the United States, interest is high, with polls showing that more than 6 in 10 American women support such access, according to the AMA. In a report from 2018, the AMA wrote that unintended pregnancy is a major public health issue in the United States, accounting for about 45 percent of all pregnancies, and is associated with increased risk of negative outcomes for mothers and infants and increased healthcare costs. A study published in March 2016 in the Journal of Women’s Health revealed that 29 percent of adult U.S. women who have ever tried to obtain a prescription or refill for contraceptive pill, patch, or ring have experienced difficulties doing so. “For many, a birth control pill may be the best option for them, but a prescription is an unnecessary obstacle that can put it out of reach," said the obstetrician-gynecologist Melissa J. Kottke, MD, in a statement. The product submitted by HRA Pharma, called Opill, is a progestin-only daily birth control treatment (also referred to as a mini pill or non-estrogen pill). Other birth control pills combine both progestin and estrogen. Opill has been available by prescription since the FDA approved it in 1973. HRA Pharma says that decades of evidence prove the pill is safe and effective at preventing pregnancy for most women. The AMA supports this type of pill as a potential first candidate for OTC oral contraceptive because progestin-only products have fewer contraindications (conditions that may cause harm if a person takes the pill) than other oral contraceptives. The Cleveland Clinic indicates that hormonal birth control can increase the risk of blood clots, but the risk is small — at most 10 in 10,000 people per year develop these clots as a result of being on birth control. A study in the journal Pediatrics found that users of progestin-only pills have a blood clot risk similar to that of non-users. The New York Times said that the application for a nonprescription birth control pill is sparking greater interest since the Supreme Court’s June decision to overturn Roe v. Wade increased public concern about reproductive rights. NEWSLETTERS Sign up for our Sexual Health Newsletter SubscribeBy subscribing you agree to the Terms of Use and Privacy Policy. The Latest in Sexual Health The Four Best At-Home STD Tests of 2022 At-home STD tests offer accurate results, and in some cases post-diagnosis care, without the need to leave your home. Check out our guide to the best ...By Chrissy HolmOctober 6, 2022 People Are Flocking to a Hotline With Their Miscarriage and Abortion QuestionsCalls to this free, anonymous service are up substantially since the fall of Roe v. 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