FDA Approves Opill as the First Over-the-Counter Oral Contraceptive in the United States

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The FDA has approved Perrigo’s Opill as the first over-the-counter oral contraceptive in the United States on July 13th. Opill was previously available only with a prescription. The manufacturer says the non-prescription version will be available for sale in pharmacies and online in early 2024.

Opill is a progestin-only medication containing 0.075 milligrams of norethindrone. Progestin thickens the cervical mucus, making it more difficult for sperm to enter the uterus. It may also disrupt ovulation, although it is less effective in this regard compared to combination pills that contain both progestin and estrogen.

When taken as directed at the same time every day, Opill is 93% effective in preventing pregnancy, which is higher than condoms, spermicides, and other non-prescription contraceptive methods. If a dose is missed, it is recommended to use additional contraception methods such as condoms for the next two days.

Opill is suitable for women of all ages. It has fewer side effects and safety risks compared to combination pills that contain both estrogen and progestin. The most common side effect is breakthrough bleeding.

Opill was first approved by the FDA as a prescription medication in 1973. Fifty years of use and scientific evidence have demonstrated that progestin-only pills effectively prevent pregnancy and are generally safe for most women. In May of this year, the FDA’s Nonprescription Drug Advisory Committee, as well as the Obstetrics and Gynecology Drugs Advisory Committee and the Reproductive and Urologic Drugs Advisory Committee, voted 17 to 0 (with no abstentions) in favor of the benefits of making Opill available over-the-counter outweighing the risks.

The issue of expanding access to contraception has become increasingly urgent since the Supreme Court overturned abortion rights last year. However, even before that, organizations such as the American Medical Association, the American College of Obstetricians and Gynecologists, and the American Academy of Family Physicians had been advocating for over-the-counter access to contraception for women of all ages. This approval is a significant victory for them. Over 100 countries around the world already provide over-the-counter contraception, while the United States has lagged behind in this regard.

There are 6 million pregnancies in the United States each year, with 45% of them being unintended. Perrigo has not disclosed the price of non-prescription Opill yet, but Frédérique Welgryn, the company’s Global Vice President of Women’s Health, stated in a press release that the company is committed to making the medication “accessible and affordable for women of all ages.” She also mentioned that the company will develop a consumer assistance program to provide free contraception to certain women.

A survey conducted by the Kaiser Family Foundation (KFF) last year found that over three-quarters of reproductive-age women prefer non-prescription contraception primarily due to its convenience. The survey revealed that the most likely users of this product include women who are already taking contraceptive pills, uninsured women, and Hispanic women.

The Affordable Care Act requires health insurance companies to cover the cost of prescription contraceptives, but it does not mandate coverage for non-prescription contraception. Some states have laws that require insurance coverage for non-prescription contraception, but most states do not. The KFF survey found that 10% of women are unable or unwilling to pay for any contraceptive expenses. Approximately 40% can afford to pay no more than $10 per month, while about one-third can afford to pay no more than $20 per month.

Boogie Nights

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