FDA OKs first over-the-counter oral birth control tablet


The U.S. Food and Drug Administration on Thursday announced it had approved norgestrel tablets for over-the-counter sales, making the medication the first instance of a non-prescription oral birth control pill to be okayed by the government in the nation's history. "Approval of this progestin-only oral contraceptive pill provides an option for consumers to purchase oral contraceptive medicine without a prescription at drug stores, convenience stores and grocery stores, as well as online," the FDA said in a press release.
The medicine, known as "Opill," is expected to be available in early 2024, its Dublin-based manufacturer, Perrigo Company, told the New York Times. While no price for the medication has been announced, Frederique Welgryn, the company's Global Vice President for Women's Health, said in a statement accompanying the FDA's announcement that Perrigo is committed to making Opill "accessible and affordable to women and people of all ages."
Norgestrel was initially approved for prescription use by the FDA 50 years ago, with Perrigo Company launching its push to make the medication available without a prescription in 2015, according to an administration memo authored by Dr. Karen Murry, Deputy Director of the FDA's Office of Nonprescription Drugs.
Subscribe to The Week
Escape your echo chamber. Get the facts behind the news, plus analysis from multiple perspectives.

Sign up for The Week's Free Newsletters
From our morning news briefing to a weekly Good News Newsletter, get the best of The Week delivered directly to your inbox.
From our morning news briefing to a weekly Good News Newsletter, get the best of The Week delivered directly to your inbox.
"Increasingly, women in some parts of the U.S. have few options once an unintended pregnancy occurs," Murry noted, in direct reference to the ongoing push by conservative legislators and activists to limit reproductive health options for women seeking to end their pregnancies. "Thus, giving women greater ability to prevent a pregnancy, rather than to face wrenching personal choices after an unintended pregnancy occurs, has the potential for individual and societal benefit."
Opill's approval comes just months after an independent panel of 17 agency advisors voted unanimously that the medication's over-the-counter benefits outweighed any potential risks, including to those users who have had breast cancer, or are on other hormone-based contraceptives at the time.
According to the FDA, "almost half of the 6.1 million pregnancies in the U.S. each year are unintended," which has been linked to "negative maternal and perinatal outcomes." A 2016 study published in the Journal of Women's Health found that nearly one-third of all women who have tried to get a prescription or refill of their hormonal contraceptives had encountered difficulties doing so.
Use of Opill according to its directions is not only safe, explained Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, but it is also "expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy."
A free daily email with the biggest news stories of the day – and the best features from TheWeek.com
Rafi Schwartz has worked as a politics writer at The Week since 2022, where he covers elections, Congress and the White House. He was previously a contributing writer with Mic focusing largely on politics, a senior writer with Splinter News, a staff writer for Fusion's news lab, and the managing editor of Heeb Magazine, a Jewish life and culture publication. Rafi's work has appeared in Rolling Stone, GOOD and The Forward, among others.
-
Exploring Georgia's southern highlands
The Week Recommends Visit Javakheti, Georgia's 'lake district', and meet the last-remaining 'spirit wrestlers' in the region
-
Delivery drivers face continuing heat danger with Trump's OSHA pick
The Explainer David Keeling is the former head of UPS and also worked at Amazon
-
Is that the buzzing sound of climate change worsening sleep apnea?
Under the radar Catching diseases, not those ever-essential Zzs
-
Kennedy's vaccine panel signals skepticism, change
Speed Read RFK Jr.'s new vaccine advisory board intends to make changes to the decades-old US immunization system
-
Kennedy ousts entire CDC vaccine advisory panel
speed read Health Secretary RFK Jr. is a longtime anti-vaccine activist who has criticized the panel of experts
-
RFK Jr. scraps Covid shots for pregnant women, kids
Speed Read The Health Secretary announced a policy change without informing CDC officials
-
New FDA chiefs limit Covid-19 shots to elderly, sick
speed read The FDA set stricter approval standards for booster shots
-
US overdose deaths plunged 27% last year
speed read Drug overdose still 'remains the leading cause of death for Americans aged 18-44,' said the CDC
-
Trump seeks to cut drug prices via executive order
speed read The president's order tells pharmaceutical companies to lower prescription drug prices, but it will likely be thrown out by the courts
-
RFK Jr. visits Texas as 2nd child dies from measles
Speed Read An outbreak of the vaccine-preventable disease continues to grow following a decade of no recorded US measles deaths
-
Shingles vaccine cuts dementia risk, study finds
Speed Read Getting vaccinated appears to significantly reduce the chances of developing Alzheimer's and other forms of dementia