The US government has approved the first birth control medication available without a prescription.
The FDA stated Thursday that women of all ages can buy Opill without a prescription. The agency stated in a statement that the action would help reduce barriers to contraception for women. Opill's producer expects it to be sold over-the-counter early in 2024.
Doctors assert that the progestin-only pill - also known as the "minipill" - is an especially secure form of contraception because it does not contain estrogen, thereby posing fewer side effects and health risks. Opill's most prevalent adverse effects include irregular bleeding, headaches, vertigo, and nausea.
The United States joins more than 100 countries worldwide that have made the birth control pill available without a prescription, including the majority of Latin American nations, India, China, and the United Kingdom.
Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, stated that daily oral contraception is safe and expected to be more effective than currently available non-prescription contraceptive methods in preventing unintended pregnancy when used as directed. In May, an FDA expert advisory panel voted unanimously to recommend that the drug be made available over the counter.
During the hearing, some scientists voiced concerns regarding the ability of young people and those with limited literacy to comprehend the instructions, which included not taking the medication if there was a history of breast cancer.
Members of the committee concluded, however, that women with breast cancer were likely already in contact with their physicians and aware that they should not use hormonal contraception. The panel concluded that Opill, which the FDA first approved in 1973, had a history of safety and efficacy in preventing pregnancies.
According to experts, women - and adolescents in particular - face a number of obstacles in gaining access to reproductive health services, such as a dearth of health insurance and difficulty finding transportation to doctor's appointments. Experts added that women also experience stigma and shame from health care providers and parents when attempting to obtain the pill.
Dyvia Huitron is among these individuals. She has had three years of difficulty obtaining the birth control tablet. At 16, the 19-year-old from McAllen, Texas, tried to get a prescription.
Her parents, who had her while they were adolescents, denied her the necessary consent out of worry that the contraception might encourage further sexually risky behavior. Ms. Huitron attended college in Alabama aged 18, where the maturity age is 19, so her parents could still access her medical information, forcing her to wait another year.
Nearly half of all pregnancies in the United States are unintended, according to studies. The debate over whether or not to make contraception more accessible has not, for the most part, generated as much controversy as the discussion surrounding abortion access.
Several medical and advocacy groups praised the FDA's decision on Thursday, including Advocates for Youth, a non-profit advocating for reproductive health rights, which called the approval "long overdue."
The organization asserts that the pill's price remains a concern, particularly for young people. The organization intends to lobby insurance providers to consider covering over-the-counter purchases. It is unknown how much Opill will cost in pharmacies, but according to the Biden administration, the pill's manufacturer, Perrigo, will determine the price.