FDA to Review French Birth Control Pill for OTC Use in the United States

Introduction

The United States Food and Drug Administration (FDA) is set to discuss the possibility of allowing a French birth control pill called Opill to become available over-the-counter (OTC) in America. If approved, Opill would be the first hormonal birth control available without a prescription in the country. The move could prove crucial in expanding access to contraception and preventing unwanted pregnancies.

Opill – A New Solution for Birth Control

Opill is an oral contraceptive that utilizes the synthetic hormone progestin to block sperm from entering the cervix and thereby, prevent pregnancy. The birth control pill has been recommended for women who can’t take combination pills because of health reasons. Opill’s manufacturer, HRA Pharma, is seeking FDA approval to distribute this product directly to consumers without a prescription.

Overcoming Barriers to Contraception Access

Reproductive rights organizations have expressed strong support for making birth control pills available over the counter. Currently, women need a prescription to obtain hormonal contraceptives in the US, which can prove challenging due to financial or logistical barriers. The American College of Obstetricians and Gynecologists, the American Medical Association, and the American Academy of Family Physicians believe that making birth control pills more easily accessible is an essential step toward reducing unwanted pregnancies.

Benefits of Over-the-Counter Birth Control Use

Contraceptive pills are available without prescription across much of the globe, including South America, Asia, and Africa. The delay in bringing this option to America has left many women with a limited selection of options when selecting an appropriate method of contraception. If approved for OTC use, Opill will offer consumers improved accessibility and flexibility when choosing a contraceptive option best suited for their needs.

Potential Risks Associated with OTC Use

Estrogen, not progestin, accounts for the majority of the blood clot risks associated with oral contraceptives. However, to ensure that women who use OTC birth control pills are not taking any undue reproductive health risks, HRA Pharma is seeking to convince the FDA that women can safely screen themselves for conditions that raise the risk of rare but dangerous blood clots when using birth control pills. Additionally, Perrigo submitted Opill’s application in July 2022, and while the FDA originally scheduled a review in November of 2022, they postponed to May 9-10th, 2023 due to needing more time to review additional application related information.

Conclusion

If the FDA approves the OTC use of birth control pills such as Opill, it could lead to profound and positive changes in public health by reducing unwanted pregnancies and expanding access to contraception. The results of this upcoming meeting will be eagerly anticipated by many advocacy groups and individuals interested in improving reproductive health care in America.

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