FDA Approves Over-the-Counter Birth Control Pills

FDA approves an over-the-counter birth control pill, Opill, to be sold without a prescription. This approval is a significant landmark as it will enable people, including young women, teenagers, and those who find it difficult to visit a doctor to obtain a prescription due to expenses and logistical hurdles, to increase access to contraception.

According to experts in reproductive health, this oral contraceptive is more effective in preventing unintended pregnancies when compared to other non-prescription methods, such as condoms or spermicides. Opill’s manufacturer, Perrigo Company, has stated that the oral contraceptive will be available in stores and online in 2024 without specifying a price. However, for individuals with limited financial resources, Perrigo has committed to providing the pill through their consumer assistance program with no or minimal cost.

Over 75% of women of reproductive age favor an over-the-counter oral contraceptive primarily due to convenience. Seventeen independent scientific advisers to the FDA unanimously decided that the benefits of the oral contraceptive outweighed the risks.

The advantages of over-the-counter pills include affordability, a crucial issue for communities impacted by systemic health inequities if priced affordably and fully covered by insurance. With this landmark decision, the FDA may broaden access to contraception, particularly in a world where 50% of all pregnancies are unintended.

BREAKING: FDA approves the first birth control pill in the U.S. that can be sold without a prescription. https://t.co/HixI0GjVoM

— ABC News (@ABC) July 13, 2023

FDA Approves Birth Control Pills Without Prescription

Birth control pills have been the most popular form of birth control, but it requires a prescription. However, this is about to change with the recent FDA approval of an over-the-counter birth control pill called Opill. The advancement is significant in contraceptive care as it allows for broader access and could help overcome the barriers that many women face, such as the cost of doctor’s visits, time off from work, and finding childcare.

Opill is expected to be an essential option for the estimated 15 million women in the U.S. who currently do not use birth control or rely on less effective methods like condoms. However, the accessibility of Opill will significantly depend on its price, which Perrigo, the manufacturer, plans to announce later this year. While over-the-counter medicines are generally cheaper, insurance typically does not cover them. Women’s advocates are pushing for a regulatory change requiring insurers to cover over-the-counter birth control, urging the Biden administration to implement this change.

Opill’s approval is not related to the abortion pill mifepristone. Anti-abortion groups do not oppose contraceptives because they do not terminate pregnancies; they prevent them. The approval of Opill provides women with another birth control option amidst the legal and political debates surrounding reproductive health, including the recent reversal of Roe v. Wade.

Opill’s Over-the-Counter Product

Opill’s as an over-the-counter product comes after years of research submitted by Perrigo to the FDA. Opill contains a single synthetic hormone with fewer side effects.

Proponents of women’s health hope this approval will pave the way for more over-the-counter birth control options and, potentially, abortion pills. An outside panel of FDA advisers unanimously voted for Opill, and many public members also advocated for its approval during a hearing.

Opill is a progestin-only pill that blocks sperm from reaching the cervix. It needs to be taken simultaneously every day for maximum effectiveness. Some of the common side effects are dizziness, headache, cramps, irregular vaginal bleeding, and headaches. But, women with a breast cancer history should not take it because it stimulates tumor growth. Additionally, certain medications for seizures, HIV, and hypertension can interfere with the pill’s effectiveness.

Perrigo plans for Opill to be available in stores early next year. This approval marks a significant advancement in contraceptive care, giving women more options and easier access to birth control.

Written by Janet Grace Ortigas

Sources:
New York Times: F.D.A. Approves First U.S. Over-the-Counter Birth Control Pill; by Pam Belluck
Associated Press: First over-the-counter birth control pill gets FDA approval; by Matthew Perrone
CNN: FDA approves first over-the-counter birth control pill; by Carma Hassan
CBS News: FDA approves first over-the-counter birth control pill, Opill

Featured and Top Image by Reproductive Health Supplies Coalition Courtesy of Unsplash
Inset Image by CaptJayRuffins Courtesy of Wikimedia – Creative Commons License