FDA Empowers Women with Landmark Approval of Over-the-Counter Birth Control Pill

FDA Advisers Approve Over-the-Counter Birth Control Pill

A Landmark Decision for Women’s Empowerment

The US Food and Drug Administration (FDA) made a historic decision on Thursday, approving the birth control pill Opill to be sold over-the-counter. This marks the first time a nonprescription birth control pill is available in the United States. Dr. Patrizia Cavazzoni, the director of the FDA‘s Center for Drug Evaluation and Research, called it a significant milestone for women’s health.

Opill, manufactured by Perrigo, is a “mini-pill” that uses only the hormone progestin. The FDA‘s decision was well-received by Perrigo, who hailed it as a groundbreaking expansion for women’s health and a giant leap for women’s empowerment. Frederique Welgryn, Perrigo global vice president for women’s health, emphasized their commitment to ensuring that Opill is affordable and accessible to those who need it.

The pill is expected to be available over-the-counter in stores by early 2024. However, the suggested retail price has yet to be communicated. Kelly Blanchard from Ibis Reproductive Health stressed the importance of ensuring insurance coverage for Opill. She stated that there is still work to be done at the state and federal level to change regulations and guarantee cost-free access to over-the-counter contraception.

Addressing Barriers to Access

The FDA‘s decision to approve over-the-counter access to Opill comes after mounting pressure from lawmakers and health care providers. Last month, President Joe Biden issued an executive order directing relevant departments to consider actions that would improve access to affordable over-the-counter contraception. The FDA acknowledged the potential positive impact on unintended pregnancies, which currently account for almost half of the 6.1 million pregnancies in the US each year.

Unintended pregnancies have been linked to negative maternal and perinatal outcomes, including the reduced likelihood of receiving early prenatal care and increased risks of preterm delivery and adverse neonatal and child health outcomes. By making Opill available without the need for a healthcare provider visit, the FDA hopes to reduce barriers to access and help reduce the number of unintended pregnancies and their negative impacts.

A Step Towards Bodily Autonomy

The approval of Opill for over-the-counter use is seen as an opportunity for individuals to take back their bodily autonomy, particularly for communities that face barriers to health care. Ann Marie Benitez from the National Latina Institute for Reproductive Justice highlighted that this decision provides an additional avenue for people to access the care they need on their own terms.

Safety and Side Effects

Opill, like other progestin-only contraceptives, is considered safe with minimal risks for adverse effects such as venous thromboembolism. The pill must be taken at the same time every day to ensure its effectiveness. However, it is contraindicated for individuals with a history of breast cancer. Common side effects include irregular bleeding, headaches, dizziness, nausea, increased appetite, and abdominal pain.

Conclusion

The FDA‘s approval of over-the-counter access to Opill marks a significant milestone in women’s health in the United States. It offers the potential for greater autonomy and accessibility to contraception, which can help reduce unintended pregnancies and their associated negative impacts. However, ensuring affordable access and insurance coverage for over-the-counter contraception remains a crucial step to address barriers to reproductive health care. The availability of Opill in early 2024 will pave the way for further discussions and actions to improve women’s reproductive health in the country.