The Food and Drug Administration this week approved the country’s first birth control pill to be sold to Americans over the counter without a prescription – 50 years after it first appeared on the market.
Experts say the FDA’s groundbreaking approval of the pill norgestrel, sold under the brand name Opill, will increase access to effective contraception for people who lack easy access to the health care system for a prescription.
“Women can already go to the drug store to buy spermicide and condoms, but those are just not as effective as birth control pills,” said Dr. Maria Sophocles, an obstetrics and gynecologist and the medical director of Women’s Healthcare of Princeton in New Jersey.
But over-the-counter approval of the progestin-only pill, commonly known as the “minipill,” also raises questions about cost, access and whether the move has the unintended consequence of reducing opportunities for sex education and reproductive care.
What is Opill?
Opill uses the synthetic hormone progestin to block sperm from the cervix, preventing pregnancy.
While most other birth control pills use progestin and estrogen, progestin-only pills like Opill are often recommended for people who can’t take combination pills for health reasons.
Hormone-based pills, like Opill, have long been one of the most common forms of birth control nationwide and have been used by tens of millions of people since the 1960s.
Norgestrel was first approved in the U.S. in 1973 and marketed by Pfizer as the prescription product Ovrette until it was discontinued in 2005 as combination birth control pills with both estrogen and progestin became more popular. In 2015, HRA Pharma acquired norgestrel and rebranded it as Opill with the sole purpose of getting government approval to sell the pill to over the counter.
The pill is currently sold without a prescription in the United Kingdom. Other contraceptive pills are available without prescription across much of the globe, including in South America, Asia and Africa.
Opill cost: Will insurance cover it?
HRA Pharma says Opill may be available to consumers in early 2024, but the company has yet to reveal how much it will cost.
Prescription birth control pills on the market range from $10 to $50 without insurance, depending on the type of pill and brand, said Dr. Carolyn Westhoff, professor of obstetrics and gynecology at Columbia University Mailman School of Public Health.
Insurance companies generally cover prescription birth control pills, but it’s unclear if they will cover over-the-counter products.
The Blue Cross Blue Shield Association, one of the country’s largest health insurance network, is leaving that decision to their 34 locally operated BCBS companies, according to company spokesperson Kelly Parsons.
It’s also unclear whether Opill will be covered by Medicaid, the government insurance program used by many low-income and disabled people, experts say. While some states cover certain over-the-counter products like emergency contraception, others don’t.
Patients who don’t have easy access to the health care system may benefit the most from over-the-counter birth control pills. But these same patients also tend to live in underserved communities and have lower income, so experts say affordability is key.
Sex education and sexually transmitted infections
The ability to get birth control pills without a prescription is not intended to replace regular doctor visits.
But some experts worry patients may be less inclined to get checkups if they no longer need refills for birth control, especially as data shows doctor appointment wait times have skyrocketed in recent years.
A 2022 survey by Merritt Hawkins, a physician search firm, found the average wait to see an OB/GYN increased from 23 days in 2004 to nearly 32 days in 2022. The longest wait time reported was a whopping 93 days in 2022.
Skipping a doctor’s visit may not only be detrimental to a person’s health but it could also be a missed opportunity to provide sexual health education – particularly among younger patients, Sophocles said.
It could contribute to already rising cases of sexually transmitted infections, as providers typically take the opportunity to test for such infections when they learn a patient is sexually active. Birth control pills do not protect against sexually transmitted infections.
Avoiding the doctor’s office could put patients at higher risk of contracting sexually transmitted infections and spreading them, Sophocles said. If left untreated, some sexually transmitted infections can lead to lifelong consequences, such as infertility.
“It’s the biggest opportunity cost that’s lost,” she said. Opill “is not a substitute to going to the clinic. You should still be seen by a clinician to have education and to know when to go.”
‘Is Opill right for you?’
While increasing access, adding Opill to the contraceptive toolkit relieves some of the stress surrounding contraception.
It means not having to scramble for or cram in a last-minute doctor’s appointment to secure pills before traveling. It means not risking an unwanted pregnancy if you run out before a refill, lose a pack or there’s a delay when changing providers.
It’s safe to temporarily switch to Opill from another progestin-only or combination birth control pill, Westhoff said, but it’s still important to consult a provider when choosing the right birth control.
For example, people with a history of breast cancer should not take the Opill, and those with abnormal vaginal bleeding should talk to a doctor first, said Dr. Asima Ahmad, chief medical officer and co-founder of Carrot Fertility, a global fertility platform.
Opill “provides an option to be able to access this form of contraception but it doesn’t replace the patient provider relationship,” she said.
Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT.
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