The US government has given its approval for the first-ever over-the-counter birth control pill, called Opill. The Food and Drug Administration (FDA) announced that Opill will be available without a prescription for women of all ages, in an effort to reduce barriers to accessing contraception. The manufacturer of Opill expects it to be available over the counter in early 2024.
Opill is a progestin-only pill, also known as the "minipill," which is considered a safe form of contraception because it does not contain estrogen, thereby reducing side effects and health risks. Common side effects of Opill include irregular bleeding, headaches, dizziness, and nausea.
The decision by the US to make the birth control pill available over the counter aligns with more than 100 other countries, including most countries in Latin America, as well as India, China, and the United Kingdom. The FDA's Center for Drug Evaluation and Research has stated that daily oral contraception, when used correctly, is safe and more effective than currently available non-prescription contraceptive methods.
The approval follows the unanimous recommendation of an FDA expert advisory panel in May. Concerns were raised during the panel hearing about whether young people and those with limited literacy would understand the directions for use, particularly regarding contraindications for women with a history of breast cancer. However, the panel concluded that women with breast cancer are likely already in contact with their doctors and aware of the need to avoid hormonal contraception.
Access to reproductive health services, including contraception, can be challenging for women, particularly teenagers, who may face barriers such as lack of health insurance, transportation difficulties, and stigma from healthcare providers and parents. The availability of birth control pills without a prescription is expected to address some of these barriers and reduce unintended pregnancies.
While the debate on contraception availability has not sparked the same controversy as abortion access, several anti-abortion groups have stated that they do not take a stance on birth control. Medical and advocacy groups, including Advocates for Youth, have praised the FDA decision, although concerns remain about the cost of the pill, especially for young people. The organization plans to advocate for insurance coverage of over-the-counter purchases. The exact price of Opill has yet to be determined by its manufacturer, Perrigo.