July 11, 2022 - A pharmaceutical company will apply for federal approval to become the first company to market an over-the-counter oral contraceptive in the United States.
The US-registered HRA Pharma Food and Drug Administration has applied to market an oral contraceptive called He Opill without a doctor's prescription, the company said in a press release.
The French-based company expects a decision from the FDA in about 10 months, The New York Times reported. Reproductive rights have become a national issue since the U.S. Supreme Court's recent ruling overturning Roe v. Wade, but HRA Pharma said the request was unrelated to the court's ruling. said The Times. “This historic filing marks a landmark moment for contraceptive access and reproductive equity in the United States,” said Frederick Wergrin, Chief Strategic Operations and Innovation Officer at HRA Pharma. “More than 60 years ago, prescription birth control pills in the United States gave women the power to plan when they wanted to conceive. and enable people to access contraception without facing unnecessary barriers.”
Doctors in the United States are supposed to prescribe oral contraceptives and check for the risk of rare but dangerous blood clots, according to the Associated Press. The AP said it includes studies that show it can screen for
 
Opill is called a minipill because it contains only the synthetic hormone progestin. Most oral contraceptives sold in the United States are ''combination pills,'' which contain estrogen and can make menstruation more regular, but account for the majority of the thrombotic risk of oral contraceptives. said AP. According to The New York Times, the minipill accounts for about 10% of the US contraceptive pill market.
FDA data shows that of her 10,000 women who take COCs each year, only three to nine of them develop blood clots, she said. . In contrast, one to five of every 10,000 women not taking contraceptives develop blood clots.
According to the Associated Press, contraceptives are already available without a doctor's prescription in many countries in South America, Asia and Africa. In the UK last year, HRA Pharma was approved to market a non-prescription oral contraceptive.
In the United States, medical groups such as the American Medical Association and the American Academy of Obstetricians, along with numerous women's rights groups, have advocated for OTC contraceptives for years.
The FDA has been criticized by conservative groups for expanding access to contraception with products like the Plan B emergency contraceptive pill. Late last year, the FDA granted permanent access to so-called abortion pills by mail.