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."
Create an account with the same email registered to your subscription to unlock access.
Sign up for Today's Best Articles in your inbox
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.
-
Today's political cartoons - May 4, 2024
Cartoons Saturday's cartoons - reflections in the pond, riding shotgun, and more
By The Week US Published
-
5 high-caliber cartoons about Kristi Noem shooting her puppy
Cartoons Artists take on the rainbow bridge, a farm upstate, and more
By The Week US Published
-
The Week Unwrapped: Why is the world running low on blood?
Podcast Scientists believe universal donor blood is within reach – plus, the row over an immersive D-Day simulation, and an Ozempic faux pas
By The Week Staff Published
-
Texas dairy worker gets bird flu from infected cow
Speed Read The virus has been spreading among cattle in Texas, Kansas, Michigan and New Mexico
By Peter Weber, The Week US Published
-
Dengue hits the Americas hard and early
Speed Read Puerto Rico has declared an epidemic as dengue cases surge
By Peter Weber, The Week US Published
-
US bans final type of asbestos
Speed Read Exposure to asbestos causes about 40,000 deaths in the U.S. each year
By Peter Weber, The Week US Published
-
The rise in illegal pregnancy termination investigations
Under the Radar 'Unprecedented' number of women being prosecuted prompts medical body to tell members not to report suspected cases to police
By The Week UK Published
-
Seattle Children's Hospital sues Texas over 'sham' demand for transgender medical records
Speed Read Texas Attorney General Ken Paxton subpoenaed records of any Texan who received gender-affirming care at the Washington hospital
By Peter Weber, The Week US Published
-
Afghanistan has a growing female suicide problem
Speed Read The Taliban has steadily whittled away women's and girls' rights in Afghanistan over the past 2 years, prompting a surge in depression and suicide
By Peter Weber, The Week US Published
-
Texas Supreme Court denies judge-approved abortion for woman with nonviable pregnancy
Speed Read Kate Cox, a Dallas mom of 2, left Texas to obtain an abortion after the state's highest court stepped in
By Peter Weber, The Week US Published
-
US life expectancy rose in 2022 but not to pre-pandemic levels
Speed Read Life expectancy is slowly crawling back up
By Devika Rao, The Week US Published