First FDA-Approved Daily Over-the-Counter Birth Control Pill ‘Empowers The Agency of Women’

Irish pharmaceutical company Perrigo announced March 4 the first FDA-approved over-the-counter daily oral contraceptive, Opill, was shipped to major retailers and pharmacies and would soon be available for purchase, according to the Perrigo website.

The U.S. Food and Drug Administration approved Opill July 13 as the first non-prescription oral birth control pill, according to the FDA website. The timeline for consumer access to Opill was then left to the manufacturer, Perrigo, and is available over-the-counter as of March.

Dr. Hille Haker, the Richard A. McCormick Chair of Catholic Moral Theology at Loyola, said she believes having over-the-counter birth control acknowledges trust in women to make decisions for themselves and care for their own bodies without outside interference. 

“I just applaud this because I want everything that empowers the agency of women,” Haker said.

Opill is 98% effective in preventing pregnancy when taken as directed, making it the most effective over-the-counter contraceptive available, according to Perrigo U.S. Women’s Health Brand Lead Leila Bahbah. For the pill to be effective, the FDA advises users to take the pill at the same time daily. Bahbah wrote in an email to The Phoenix users must continue to take the pill everyday unless they decide they want to become pregnant.

“The availability of Opill means that for the first time in history, no permission is required to access a birth control pill. Opill provides an easier way to both start and continue using an effective and safe daily birth control pill consistently,” Bahbah wrote. 

The most common side effects of Opill include changes in the users’ bleeding pattern, such as period frequency, changes in flow strength and length of period, according to Opill. Headaches, dizziness, nausea, increased appetite, abdominal pain, cramps and bloating are less common side effects. Opill isn’t safe for women who have or have had breast cancer.

Opill is an estrogen-free contraception option, according to the Opill website. The active ingredient in the drug — norgestrel — was first approved by the FDA for prescription use in daily birth control in 1973, according to the Opill website. In 2015, HRA Pharma then began research needed to apply to the FDA to change Opill from prescription to over-the-counter. 

The drug can be found at retailers such as CVS, Walgreens, Target, Amazon or directly on the Opill website for $19.99 for a one month supply, according to a Perrigo spokesperson. They said currently only Perrigo manufactures this product.

Senior Manager of Retail Communications at CVS Matthew Blanchette wrote in an email to The Phoenix Opill is available at more than 7,500 CVS Pharmacy stores, the CVS website and the CVS Pharmacy app. Buyers can also choose same-day delivery or buy online to pick up in-store for added privacy, according to Blanchette. 

A Walgreens spokesperson wrote Opill has been available nationwide in the family planning aisle and behind the pharmacy at Walgreens since March.

The Perrigo spokesperson said since the product has hit shelves, the company has been communicating with insurance companies, specifically CVS Caremark, who will begin covering Opill. They said the drug could then be picked up from pharmacies without a prescription free of charge. 

Haker said Richard A. McCormick was a Jesuit, moral theologian who worked in the field of medical ethics and was known for his liberal and contextual approach to sexual morality. She said her approach to ethics closely reflects McCormick’s by staying true to the Church’s teaching while voicing her dissent towards the church’s historical opposition to chemical contraceptives.

Haker said access to contraceptives can be scarce or even impossible for many groups of people due to financial or cultural reasons. She said having access to Opill over-the-counter could potentially be particularly impactful for Black women who have historically been mistreated by doctors and gynecologists. 

In a study by the National Library of Medicine, researchers found 58% of white women received oral contraceptives compared to only 36-54% of other racial and ethnic groups. 

Haker said she believes young women and adolescents may also benefit from the availability of Opill because they won’t have to rely on their parents or caretakers to help them access the contraceptives they need. 

“I believe that hopefully every woman has a gynecologist and gets the access to healthcare as needed,” Haker said. “Then they can discuss contraceptives of whatever kind with their doctors, but that should not be the bottleneck for having contraceptives.”

Haker said she believes the topic of contraceptives is a complex conversation since it closely intertwines with questions of intimacy, relationships and identity. She said she thinks having access to Opill opens the door for women to make what they believe to be responsible choices.

“This decision of the FDA is an occasion to rethink where we stand, where we are and what conversations we would like to have on campus and off campus, amongst ourselves and with our university,” Haker said.

Marina Marotto, a third-year public health student, said more unrestricted access to contraceptives, like Opill, is a big win for the public health community. As abortion access continues to be limited in some states since the overturning of Roe v. Wade in June 2022, Marotto said access to contraceptives becomes even more important. 

She said though she was excited about the authorization of non-prescription birth control, the next step in the fight for reproductive rights is to reinstate Roe v. Wade to protect the right to abortion. 

“I think we can’t forget about contraceptives,” Marotto said. “Because in the states that abortion is banned in—contraceptives are the next step to ban.”

Marotto said it terrifies her to think people could lose access to birth control since she has been relying on it since she was 15-years-old to have a well-functioning lifestyle. She said she hopes the cost of Opill is able to decrease to make it more accessible to a wider variety of people. 

Joan Holden, assistant vice president of student health and wellness, said having Opill available in stores won’t change how doctors interact with and help patients but will just be something noted in the patient’s health history. Holden said the Loyola Wellness Center will be operating the same as usual when it comes to helping students. 

Maeve Donovan, co-president of Women in Leadership Loyola, said as a nursing major, she is taught to consider social determinants of health and socio-economic class when helping patients to understand where they are coming from. She said she believes having more access to oral contraceptives will alleviate stressors like making doctor’s appointments or finding transportation. 

Donovan said she believes birth control is a human right because it gives women autonomy over their bodies to make decisions as they choose. She said limited access to birth control and abortion control how women use their bodies. 

“In Women in Leadership, we talk a lot about student’s experiences with having access to types of birth control and how that access is limited in many of their lives or in women’s lives across the country,” Donovan said.

Dr. Sandra Sullivan-Dunbar, an associate professor in the theology department, said she’s working on a book concerning Catholic moral theology and reproductive justice. She said to many people, the combination of the two topics seems like an oxymoron, but she chooses to explore how being a moral agent applies to women’s ability to manage their reproductive choices. 

“What it means to be a moral agent is basically to plan a life where you can do good things for yourself and other people and pick up responsibilities and make the world a better place,” Sullivan-Dunbar said. “Being able to effectively control your reproductive life is part of that, so it’s unjust to take that away from people.”

Sullivan-Dunbar said she believes it’s a social injustice and a violation of a person if pregnant-capable people are unable to decide when they want to get pregnant. She said reproductive decisions are life changing decisions, which is why she supports having birth control as accessible as possible.

Featured Image by Austin Hojdar / The Phoenix