Please ensure Javascript is enabled for purposes of website accessibility
First Over-the-Counter Birth Control Pill Gets Federal Approval
By admin
Published 2 years ago on
July 13, 2023

Share

Getting your Trinity Audio player ready...

U.S. officials have approved the first over-the-counter birth control pill, which will let American women and girls buy contraceptive medication from the same aisle as aspirin and eyedrops.

The Food and Drug Administration said Thursday it cleared Perrigo’s once-a-day Opill to be sold without a prescription, making it the first such medication to be moved out from behind the pharmacy counter. The company won’t start shipping the pill until early next year, and there will be no age restrictions on sales.

Hormone-based pills have long been the most common form of birth control in the U.S., used by tens of millions of women since the 1960s. Until now, all of them required a prescription.

Medical societies and women’s health groups have pushed for wider access, noting that an estimated 45% of the 6 million annual pregnancies in the U.S. are unintended. Teens and girls, women of color and those with low incomes report greater hurdles in getting prescriptions and picking them up.

Some of the challenges can include paying for a doctor’s visit, getting time off from work and finding child care.

“This is really a transformation in access to contraceptive care,” said Kelly Blanchard, president of Ibis Reproductive Health, a non-profit group that supported the approval. “Hopefully this will help people overcome those barriers that exist now.”

Ireland-based Perrigo did not announce a price. Over-the-counter medicines are generally much cheaper than prescriptions, but they aren’t covered by insurance.

Many common medications have made the switch to non-prescription status in recent decades, including drugs for pain, heartburn and allergies.

Perrigo submitted years of research to FDA to show that women could understand and follow instructions for using the pill. Thursday’s approval came despite some concerns by FDA scientists about the company’s results, including whether women with certain underlying medical conditions would understand they shouldn’t take the drug.

FDA’s action only applies to Opill. It’s in an older class of contraceptives, sometimes called minipills, that contain a single synthetic hormone and generally carry fewer side effects than more popular combination hormone pills.

But women’s health advocates hope the decision will pave the way for more over-the-counter birth control options and, eventually, for abortion pills to do the same.

Approval Process Pre-Dates Abortion Ruling

That said, FDA’s decision has no relation to the ongoing court battles over the abortion pill mifepristone. The studies in Perrigo’s FDA application began years before the Supreme Court’s reversal of Roe v. Wade, which has upended abortion access across the U.S.

With some states curtailing women’s reproductive rights, the FDA has faced pressure from Democratic politicians, health advocates and medical professionals to ease access to birth control. The American Medical Association and the leading professional society for obstetricians and gynecologists backed Opill’s application for over-the-counter status.

An outside panel of FDA advisers unanimously voted in favor of the switch at a hearing in May where dozens of public speakers called for Opill’s approval.

Dyvia Huitron was among those who presented, explaining how she has been unable to get prescription birth control more than three years after becoming sexually active. The 19-year-old University of Alabama student said she still isn’t comfortable getting a prescription because the school’s health system reports medical exams and medications to parents.

“My parents did not let me go on the pill,” Huitron said in a recent interview. “There was just a lot of cultural stigma around being sexually active before you’re married.”

While she uses other forms of contraception, “I would have much preferred to have birth control and use these additional methods to ensure that I was being as safe as possible.”

Huitron spoke on behalf of Advocates for Youth, one of the dozens of groups that have pushed to make prescription contraceptives more accessible.

The groups helped fund some of the studies submitted for Opill and they encouraged HRA Pharma, later acquired by Perrigo, to file its application with the FDA.

Advocates were particularly interested in Opill because it raised fewer safety concerns. The pill was first approved in the U.S. five decades ago but hasn’t been marketed here since 2005.

“It’s been around a long time and we have a large amount of data supporting that this pill is safe and effective for over-the-counter use,” said Blanchard, of Ibsis Reproductive Health.

Newer birth control pills typically combine two hormones, estrogen and progestin, which can help make periods lighter and more regular. But their use carries a heightened risk of blood clots and they shouldn’t be used by women at risk for heart problems, such as those who smoke and are over 35.

Opill has only progestin, which prevents pregnancy by blocking sperm from reaching the cervix. It must be taken around the same time daily to be most effective.

In its internal review published in May, the FDA noted that some women in Perrigo’s study had trouble understanding the drug’s labeling information. In particular, the instructions warn that women with a history of breast cancer should not take the pill because it could spur tumor growth. And women who have unusual vaginal bleeding are instructed to talk to a doctor first, because it could indicate a medical problem.

Perrigo executives said the company will spend the rest of the year manufacturing the pill and its packaging so it can be available in stores nationwide and online by early next year.

RELATED TOPICS:

DON'T MISS

What Are Fresno Real Estate Experts Predicting for 2025 and Beyond?

DON'T MISS

First California EV Mandates Hit Automakers This Year. Most Are Not Even Close

DON'T MISS

Louisiana’s Ten Commandments Law Struck Down by US Appeals Court

DON'T MISS

Voice of America Parent Terminates Over 600 More Staff in Likely Death Knell

DON'T MISS

Trump Administration Says It Is Suspending Enforcement of Biden-Era Farmworker Rule

DON'T MISS

Fresno County’s Ruth Fire Destroys Structure in Yokuts Valley

DON'T MISS

Ninth Circuit Strikes Down CA’s ‘One-Gun-Per-Month’ Law

DON'T MISS

USDA Develops Potential Plan to Vaccinate Poultry for Bird Flu

DON'T MISS

Trump Says He May Support Israel-Iran Ceasefire ‘Depending on Circumstances’

DON'T MISS

Fresno Now Has a Professional Shakespeare Co. Thanks to Measure P Sales Tax

DON'T MISS

Trump Says a Deal With Harvard Is Possible Over Next Week

DON'T MISS

Ohio Man Charged for Allegedly Threatening US Congressman Max Miller

UP NEXT

‘Little Lobbyists’ Urge Senators to Oppose Trump’s Bill Cutting Medicaid

UP NEXT

US FDA Approves Gilead’s Twice-Yearly Injection for HIV Prevention

UP NEXT

Wired Wednesday: Physician Alleges Improper Inmate Care at Fresno County Jail

UP NEXT

US to Drop Guidance to Limit Alcohol to One or Two Drinks per Day, Sources Say

UP NEXT

General Mills to Remove Artificial Colors From All Its US Cereals and Foods

UP NEXT

US FDA to Shorten Review Time for Drug Developers Under New Voucher Program

UP NEXT

Physician Warns Fresno County Supervisors About Jail’s Medical Provider, Private Equity Co.

UP NEXT

Kaweah Health CEO Says He’s Ready to Retire After 34 Years at Hospital

UP NEXT

Liquor Licenses Abound in the Valley. How Many Is Too Many?

UP NEXT

Life-Threatening Meals: Restaurants Would Identify Food Allergens for Diners Under This Proposed Law

Fresno County’s Ruth Fire Destroys Structure in Yokuts Valley

7 hours ago

Ninth Circuit Strikes Down CA’s ‘One-Gun-Per-Month’ Law

7 hours ago

USDA Develops Potential Plan to Vaccinate Poultry for Bird Flu

7 hours ago

Trump Says He May Support Israel-Iran Ceasefire ‘Depending on Circumstances’

7 hours ago

Fresno Now Has a Professional Shakespeare Co. Thanks to Measure P Sales Tax

8 hours ago

Trump Says a Deal With Harvard Is Possible Over Next Week

8 hours ago

Ohio Man Charged for Allegedly Threatening US Congressman Max Miller

8 hours ago

Town Hall Unveils New Season With Best-Selling Authors, ‘Jeopardy!’ Host, and More

9 hours ago

Trump Says His Spy Chief Gabbard Wrong on Iran’s Nuclear Program

9 hours ago

Fresno Police Investigate Fatal Shooting, Seek Public’s Help

10 hours ago

Louisiana’s Ten Commandments Law Struck Down by US Appeals Court

A federal appeals court on Friday blocked Louisiana from enforcing a law requiring the display of the Ten Commandments in all classrooms of ...

6 hours ago

Louisiana Attorney General Liz Murrill leaves the U.S. Supreme Court after justices heard arguments in an appeal by President Joe Biden's administration of restrictions imposed by lower courts on its ability to encourage social media companies to remove content deemed misinformation, in Washington, U.S., March 18, 2024. (Reuters File)
6 hours ago

Louisiana’s Ten Commandments Law Struck Down by US Appeals Court

A view of the Voice of America (VOA) building, a day after more than 1,300 of the employees of the media broadcaster, which operates in almost 50 languages, were placed on leave in Washington, D.C., U.S. March 16, 2025. (Reuters File)
6 hours ago

Voice of America Parent Terminates Over 600 More Staff in Likely Death Knell

A farmworker repairs irrigation lines at a tomato farm in Woodland, California, U.S. May 30, 2025. (Reuters File)
7 hours ago

Trump Administration Says It Is Suspending Enforcement of Biden-Era Farmworker Rule

The Ruth Fire in Yokuts Valley has burned 14 acres, destroyed one structure on Friday, June 20, 2025,, and is 20% contained as firefighters continue battling the blaze in steep terrain. (CalFire)
7 hours ago

Fresno County’s Ruth Fire Destroys Structure in Yokuts Valley

A federal appeals court struck down California’s “one-gun-per-month” law Friday, June 20, 2025, in a 3-0 decision, ruling it unconstitutional under the Second Amendment. (Shutterstock)
7 hours ago

Ninth Circuit Strikes Down CA’s ‘One-Gun-Per-Month’ Law

Cage-Free chickens are shown inside a facility in Lakeside, California, U.S., April 19, 2022. Picture taken April 19, 2022. (Reuters File)
7 hours ago

USDA Develops Potential Plan to Vaccinate Poultry for Bird Flu

President Donald Trump disembarks Air Force One upon his arrival at Morristown Municipal Airport in Morristown, New Jersey, U.S., June 20, 2025. (Reuters/Ken Cedeno)
7 hours ago

Trump Says He May Support Israel-Iran Ceasefire ‘Depending on Circumstances’

8 hours ago

Fresno Now Has a Professional Shakespeare Co. Thanks to Measure P Sales Tax

Help continue the work that gets you the news that matters most.

Search

Send this to a friend