US approves first ever OTC birth control pill.
Birth control pill: The first-ever over-the-counter birth control pill has been approved by the US government.
The Food and Drug Administration (FDA) announced that Opill, a progestin-only pill also known as the “minipill,” will be available without a prescription for women of all ages.
This decision aims to reduce barriers to contraception access for women.
The manufacturer of Opill, Perrigo, anticipates it will be available over the counter in early 2024.
According to doctors, the progestin-only pill is considered a safe contraceptive option as it lacks estrogen, which results in fewer side effects and health risks.
Common side effects of Opill include irregular bleeding, headaches, dizziness, and nausea.
The United States now joins over 100 countries, including the United Kingdom, China, India, and most Latin American countries, in making the birth control pill available over the counter.
FDA Director
Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, emphasized that when used as directed, daily oral contraception is safe and expected to be more effective than nonprescription methods in preventing unintended pregnancies.
The FDA expert advisory panel, which unanimously recommended the pill’s availability over the counter in May, played a crucial role in the approval process.
During the advisory panel’s hearing, concerns were raised about the ability of young people and those with limited literacy to understand the directions, such as avoiding the prescription if they had a history of breast cancer.
However, the committee concluded that women with breast cancer are likely to be in contact with their doctors and aware of the contraindications with hormonal contraception.
The approval of over-the-counter birth control is seen as a positive step toward improving reproductive health services and reducing barriers for women, particularly teenagers.
Barriers include a lack of health insurance, transportation difficulties in accessing doctor’s appointments, and stigma or shame faced from healthcare providers and parents when seeking the pill.
Barriers
The article highlights the experience of Dyvia Huitron, who faced obstacles in accessing the birth control pill due to parental concerns.
She reflects on the challenges she encountered in obtaining a prescription and her fear of repeating her parents’ experiences as teen parents.
Medical professionals and activists argue that making birth control available without a prescription will have numerous health benefits, including reducing unintended pregnancies.
Studies in the US have shown that nearly half of all pregnancies are unintended.
Unlike the controversy surrounding abortion access, the debate on making contraception more readily available has not sparked significant opposition from anti-abortion groups.
The FDA decision received praise from various medical and advocacy organizations, with Advocates for Youth describing it as “long overdue.”
While the price of the pill remains a concern, particularly for young individuals, the organization plans to advocate for insurance companies to consider covering over-the-counter purchases.
The exact cost of Opill at pharmacies is yet to be determined, as it will be determined by Perrigo, the manufacturer, with guidance from the Biden administration.
Source: BBC