The FDA approved the US’ first over-the-counter birth control pill. What happens next?

By Amanda Musa, CNN

(CNN) — The US Food and Drug Administration has approved the oral contraceptive Opill for over-the-counter use, making it the first nonprescription birth control pill in the United States, but it will be months before it’s available.

The pill is expected to be on shelves in early 2024. The American College of Obstetricians and Gynecologists called it “a critically important advancement in the accessibility of reproductive health care.”

“Barriers to access are one reason for inconsistent use or lack of use of contraception,” ACOG said in a statement after its approval. “Allowing individuals to access birth control at their local pharmacy or drug store will eliminate some barriers, such as taking time off work for an appointment, paying an office visit copay, or navigating sometimes-confusing prescription refill protocols.”

Here’s what you need to know about how Opill differs from other forms of oral contraception, how much it might cost and what challenges may lie ahead.

What is Opill?

Opill is a “mini-pill” that uses progestin, a synthetic form of the hormone progesterone, and does not contain estrogen. The typical combination birth control pill, the most commonly used form of oral contraception, uses both hormones to prevent pregnancy.

The 0.075-milligram norgestrel tablet was approved for prescription use by the FDA in 1973. Opill is about 98% effective if taken as directed, at the same time every day, according to the FDA.

Opill is not emergency contraception or abortion medication.

Several similar “mini-pills” are also available with a prescription, but Opill is the only oral contraceptive that is approved to buy without a prescription.

Most progestin-only birth control works by creating thick cervical mucus that makes it difficult for sperm to enter the uterus and fertilize an egg, according to ACOG. In some cases, progestin stops ovulation from occurring; however, about 40% of women taking “mini-pills” will continue to ovulate.

Dr. Carolyn Westhoff, who specializes in obstetrics and gynecology at Columbia University, said that when they’re used as directed, progestin-only pills are just as effective as combination pills.

“Progestin alone is sufficient for contraceptive efficacy. The addition of estrogen helps give more regular bleeding and can also enhance the effectiveness of progesterone. Adding estrogen has some benefits, but it is not necessary for contraceptive effectiveness,” she said.

Opill can also be viewed as a medical tool, not only to prevent pregnancy, said Dr. Kristyn Brandi, an ob/gyn in New Jersey and the chair of the Board of Directors for Physicians for Reproductive Health.

“People use birth control for things outside of preventing pregnancy like [polycystic ovary syndrome], treating heavy periods, painful periods,” she said. “There’s a lot of uses for it outside of birth control that people also will benefit if they can get it over the counter.”

Who can use Opill?

There is no age limit to buy Opill.

This could have a major impact for adolescents and young adults who may not otherwise have the resources to access birth control, according to Brandi.

“Teenagers have so many barriers to accessing reproductive health care, like birth control, that many of them just never make it to an appointment to get that care,” Brandi said.

Dr. Anne-Marie Amies Oelschlager, chair of ACOG’s Clinical Consensus Committee on Gynecology, said Opill can also be a good short-term alternative for someone with limited resources.

“If someone is waiting to get into a health care provider but needs birth control right away, they can start Opill until they can see a provider and discuss all the contraceptive options available,” she said.

Brandi believes the approval of Opill can help bring peace of mind to marginalized groups.

“There’s a lot of reasons why people may not want to engage in the health care system but still need [birth control] for their own well-being,” she noted, such as racism or transphobia in medicine.

Opill side effects and uses

Amies Oelschlager said in a statement that oral contraceptives that contain estrogen may cause side effects such as headaches, nausea, and breast tenderness.

Opill may have some similar side effects, including “irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps or bloating,” according to the FDA.

However, Amies Oelschlager said, “Progestin-only methods are safer for people who have migraine headaches, uncontrolled blood pressure, and those who are at high risk of blood clots.”

Opill costs and insurance coverage

Opill’s cost is one of the biggest unknowns after its OTC approval, and it’s not clear whether the contraceptive will be covered by insurance.

“I think the short answer is, we don’t know yet,” said Dr. Jennifer Robinson, an assistant professor of complex family planning in the Department of Gynecology and Obstetrics at Johns Hopkins University.

“When [emergency contraception] Plan B went over-the-counter, there was a lot of concern that its over-the-counter status would change the insurance plan’s willingness to pay for it,” she said.

Today, Plan B is often covered by insurance even though it is available over the counter.

“I think there is a decent chance that insurers will still pay for Opill even though there are similar products available for prescription,” Robinson said.

Frederique Welgryn, Perrigo’s global vice president for women’s health, said last week that the company is “committed to ensuring that Opill is affordable and accessible to people who need it.” The suggested retail price will be communicated in the coming months, she said.

Last month, President Joe Biden issued an executive order directing the secretaries of Treasury, Labor, and Health and Human Services “to consider new actions to improve access to affordable over-the-counter contraception.”

“These actions could include convening pharmacies, employers, and insurers to discuss opportunities to expand access to affordable over-the-counter-contraception; identifying promising practices regarding the coverage of over-the-counter contraception at no cost to patients; and providing guidance to support seamless coverage of over-the-counter contraception,” a White House fact sheet about the orders reads.

The Affordable Care Act is required to “cover contraceptive methods and counseling for all women, as prescribed by a health care provider,” according to healthcare.gov. However, it is unclear whether the ACA will cover nonprescription contraception such as Opill.

Low cost and easy access to Opill could help address the large number of unintended pregnancies in the US, experts say. Almost half (46%) of the 6.1 million pregnancies in the nation each year are unintended, according to the FDA.

Challenges to OTC birth control

Some experts fear legal challenges to Opill’s approval after the US Supreme Court’s Dobbs decision and a district judge’s ruling this year challenging the FDA’s approval of the abortion drug mifepristone.

“I think the outcome of the mifepristone case could certainly have implications for Opill’s approval or any drug approval,” Robinson said. “[Could] this open up all drugs that are approved by the FDA to somehow be challenged by somebody who disagrees with the use of the medication?”

But some experts are hopeful that the over-the-counter approval of Opill will shift how contraception is viewed over time.

“My hope is that the more we normalize the fact that lots of people have sex, and they don’t always want to get pregnant. … That is an acknowledged and normal part of human behavior,” Robinson said. “My hope is that this will just become normal and not extraordinary in any way.”

CNN’s Meg Tirrell contributed to this report.

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