An advisory panel of experts have unanimously recommended to the U.S. Food and Drug Administration (FDA) that the agency allow women to obtain a birth control pill without a prescription. The panel had been asked whether the benefits of selling the HRA Pharma birth control pill Opill outweighed the risks of consumers improperly using the medication resulting in unintended pregnancy.
Paris-based HRA Pharma expects a final decision by the FDA this summer on its application for nonprescription sales of Opill, which is generically called norgestrel. Since they were approved in the United States more than 60 years ago, oral contraceptives have only been available to women with a prescription for their use.
If the FDA approves HRA Pharma’s application, women could obtain Opill without first having to visit a doctor or other health-care provider.
The FDA originally approved norgestrel in 1973 as a prescription drug, but the company stopped U.S. sales of the pill in 2005. HRA Pharma updated the pill’s label in 2017 in hopes of reintroducing the medication to the U.S. market, explicitly as an over-the-counter drug.
HRA Pharma submitted its application to the FDA last summer, two weeks after the Supreme Court abolished federal abortion rights by overturning its landmark 1973 Roe v. Wade decision, which led some states to ban abortion or place tight restrictions on the procedure, and also to legal efforts to pull abortion medication from the U.S. market.
Norgestrel contains a hormone called progestin that prevents pregnancy by thickening the cervix mucus to block sperm from reaching and fertilizing an egg. The pill is meant to be taken at the same time daily. Progestin-only pills typically are used by women who do not want to take the more common combination pills that contain progestin and estrogen for health reasons.
Medical associations such as the American College of Obstetricians and Gynecologists (ACOG) for years have urged over-the-counter sales of birth control pills be allowed. According to the ACOG, progestin-only pills are an effective birth control method, but it’s crucial to take the pill at the same time every day, according to the American College of Obstetricians and Gynecologists.
In typical real-word use, about 9 in 100 women will get pregnant in the first year taking the pill, according to the medical association. When the patient never forgets to take a pill, fewer than 1 in 100 women get pregnant during the first year.