Over-the-Counter Birth Control: What You Need To Know, According to an Expert
It might not work for your needs.
Over-the-counter birth control is available in more than 100 countries. Presently, the United States is not one of them. That might, however, change soon. Several pharmaceutical companies are currently seeking FDA approval for over-the-counter, non-prescription contraceptive pills. As seminal as that approval would be, there are some important things you need to know about these pills before trying them — as they may or may not be the right fit for you and your needs.
Is it safe for a birth control pill to become over-the-counter?
In the U.S., a prescription from a doctor has always been required to access birth control, which is why some are concerned about expanding that accessibility. But according to Sophia Yen, MD, MPH, CEO, and co-founder of Pandia Health — the only doctor-led, women-led, and women-founded birth control delivery service (and it offers telemedicine services in 15 states) — it’s totally safe to go over-the-counter. “The American College of Obstetrics and Gynecology (ACOG) is the authority that OBGYNs adhere to, and they’ve said that over-the-counter access to birth control is safe,” she states.
What does it take for a pill to become over-the-counter?
A lot, it turns out. A pharmaceutical company submits an application to the United States Food and Drug Administration (FDA), and their pill has to be approved, which involves a lengthy and rigorous testing process and a lot of money — about five to ten million dollars, estimates Dr. Yen. Though there are several formulations of birth control pills, only two are set to become available over-the-counter in the relatively near future. The first one is Opill, a progesterone-only pill from HRA Pharma, and the company submitted their application in July 2022. The second is a progesterone and estrogen combination pill from Cadence Health called Zena; though they’ve not yet submitted their application to the FDA, they’re allegedly close to submitting, says Politico.
What is the Opill?
As of right now, HRA Pharma is the only company to have submitted an application for their birth control, Opill, to go over-the-counter. It typically takes 10 months for the full review process to be completed. If their application is approved, birth control will become a lot more accessible for women, making healthcare more convenient. However, while testing ensures the pill is safe, Opill still might not be the best fit for you or your needs. Here are the Opill’s pros and cons, according to Dr. Yen:
Pros: Because it’s progesterone-only, it’s good if you’re breastfeeding, if you have contraindications to estrogen, or a known blood clotting disorder. It’s also safer for people who are smokers, or are older than 35.
Cons: It carries a pregnancy risk. You could end up pregnant if you take it late by three hours. “Maybe you overslept, you traveled, you went to a movie, or you went out late that night because you had a hot date (which is what you need this for!). If you had sex in the past five days, then you’re going to need some emergency contraception,” Dr. Yen warns. Combination birth control pills (which contain estrogen and progesterone) allow for more leeway — potentially up to a day or more.
What about the other pill that may go over-the-counter?
The second pill that may go over-the-counter is a combination pill from Cadence Health called Zena. Last year, the company mentioned that it “hoped…to submit an application in the coming year,” so it’s not currently known when it may be available over-the-counter. But Dr. Yen notes there are important things to know about this pill before it becomes widely accessible.
Pros: Because it has progesterone and estrogen, it’s more forgiving. Though you should take pills on time, you can take it more than three hours late, and it won’t be a major pregnancy risk.
Cons: It’s low-dose, and [as an adolescent medicine specialist], Dr. Yen doesn’t recommend less than 30 micrograms of estrogen in your pill until you’re 30, because you need it for building up bone density. Research shows that prolonged use of oral contraceptives, particularly those with less than 30 micrograms of estrogen, may adversely impact young adult women’s bone density.
If I can get birth control over-the-counter, can I still get medical advice about it?
Yes — always consult a medical professional about your needs, questions, and concerns. Consider telemedicine, which is a form of online doctor’s visit, to get convenient care and advice. Just remember that not all telemedicine is created equal, says Dr. Yen.
Before trusting someone with your health, do some research. Is the person in charge qualified to give medical advice for your specific needs? “You don’t want your ophthalmologist being a chief medical officer for a birth control company,” Dr. Yen points out. Are they transparent about the staff and their credentials? “Do they list their doctors’ first and last name? I’ve been on websites and they’re like, ‘Pharmacist Sherry would be happy to answer your questions!’ And I wonder, why won’t you tell me her last name? Is she fictional?” Dr. Yen notes that at Pandia Health, they list their staff’s full titles, academic credentials, and why they’re passionate about women’s health.
“[Look for] expert care by expert doctors. People who know their stuff. People who are passionate. People who are here for the long game — not just to make a profit off of you,” Dr. Yen concludes. “And beware, the cheapest is not always the best. This is your health. You don’t want the most expensive but you want the good stuff, and you want somebody who knows their stuff.”
The Bottom Line
Your health is important, which is why the prospect of over-the-counter birth control — which is widely used for purposes other than contraception, including treatment of medical conditions like painful periods, endometriosis, and acne — is significant. Talk to your doctor about what’s best for you. To learn more about Dr. Yen and Pandia Health, visit their website.
This interview has been edited for length and clarity.
This content is not a substitute for professional medical advice or diagnosis. Always consult your physician before pursuing any treatment plan.