FDA to Take Into Account Making Birth Control Pill Available Over-the-Counter.

The Food and Drug Administration (FDA) will convene in May to discuss whether to allow the birth control pill Opill to be sold over the counter.

Currently, Opill can only be obtained with a prescription; however, if approved, it would become the first birth control pill to be sold without a prescription in the US. In order to increase access to contraceptives and remove barriers, the American Medical Association and other health organizations have called for the approval of over-the-counter birth control.

A Progestin-Only “Mini-Pill” is called an Opill.

Opill, a progestin-only medication produced by French pharmaceutical company HRA Pharma, is referred to as a “mini-pill.” because it lacks estrogen, which raises the risk of blood clotting, as opposed to combination birth control pills, which contain both progestin and estrogen. Instead, it makes it more challenging for sperm to enter the uterus and fertilize an egg by thickening the mucus in the cervix. Although progestin-only pills do not stop ovulation as effectively as combination pills, the American Academy of Family Physicians still deems them to be “safe and effective”

The movement to switch from prescription to over-the-counter occurs in the midst of court cases involving women’s reproductive rights. The Roe v. Wade decision, which established an abortion right as guaranteed by the Constitution, was overturned by the Supreme Court in June 2022. A federal judge in Texas is also going to decide whether to impose a federal injunction on the drug mifepristone, which is one of two drugs used in medication abortions. Removal of the prescription requirement, according to proponents of over-the-counter birth control, would eliminate needless barriers to care, particularly for marginalized communities.

In May, the FDA Advisory Committee will meet.

The FDA has scheduled its eagerly anticipated advisory committee meeting for May 9–10 to talk about whether Opill can be used without a prescription. Originally scheduled for November 2022, the joint meeting of the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee was postponed to allow for the review of additional information requested by the company. Perrigo had hoped for an approval in the first half of 2023 after acquiring Opill in May 2022 when it acquired HRA Pharma in a $1.9 billion deal.

Over-the-Counter Access Benefits

Since 45% of pregnancies in the US are unintended, having access to effective birth control is essential for maintaining public health. For the millions of American women who reside in so-called contraceptive deserts, which are regions lacking funding from federal and state programs like Title X and Medicaid to operate the number of low-cost family planning clinics required to serve a given population, over-the-counter birth control offered at typical pharmacies would be a blessing. For young people and low-income people who cannot afford to see a doctor or pay for childcare and transportation to appointments, over-the-counter birth control access could also remove barriers.

Featured image: Béria L. Rodríguez, CC BY-SA 3.0, via Wikimedia Commons

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