FDA Approves First Over-The-Counter Birth Control -- Here's What This Means
TBD Health clinician Adrienne Ton shares the expert tea.
UPDATE (July 19, 2023): At-home STI testing company, TBD Health, taps in-house clinician Adrienne Ton, to share details on over-the-counter birth control. Specifically, safety and accessibility for women.
As a healthcare provider, I’m excited to see the FDA approve an over the counter birth control pill. This will open up more opportunities to empower people with uteruses in planning their futures.
The recently approved Opill, is a progesterone-based oral contraceptive. In other words, it’s what some people refer to as a mini pill, which contains only norgestrel, a progestin type of hormone that mainly helps prevent pregnancy by thickening cervical mucus and thinning the lining of the uterus, mainly preventing sperm from reaching an egg. Unlike the traditional pill or combined pill, there is no estrogen component in the medication and therefore this pill can be used by more people, such as those with a history of migraines with aura or tobacco use.
This type of birth control is a safe and effective option for most people with uteruses. Similar medications are already over the counter in 100+ other countries and are already routinely prescribed and used in the US now. There are very few reasons why this medication can’t be used (such as a history of breast cancer).
In terms of efficacy, it can be very effective at preventing pregnancy. If you take this type of pill every day at the same time without a break in monthly packs, Less than 2 in 100 people who use this type of birth control will become pregnant!
Just as with all medications available over the counter like Acetaminophen or Tylenol, there are some risks and generally mild side effects that can happen, like nausea, headaches, or irregular vaginal bleeding. However, most people will find that the benefit of pregnancy prevention outweighs those risks.
This approval opens up the access to much needed medication during today’s political climate, in which many people cannot access reproductive health care. The availability of an over-the-counter option like Opill can eliminate the requirement of obtaining a prescription, which can be a barrier for some due to factors such as lack of trusted healthcare providers nearby, lack of time off for medical appointments, or insurance coverage. This is especially true for people like those under 18 who might have concerns about privacy.
From my understanding, this pill won’t be available over the counter until early 2024. While we don’t know the exact out of pocket cost now, I’m hopeful that it will be reasonably priced. There will be some coupon programs through the pharmaceutical company. Beyond that, there is still work being done on trying to make this affordable for people. Currently, many insurers don’t cover over the counter medication. There are already lawmakers and advocates working to try to ensure insurance coverage of this kind of pill, so that it’s free or low cost for most people.
According to a report released by the FDA today, “approved Opill (norgestrel) tablet for nonprescription use to prevent pregnancy — the first daily oral contraceptive approved for use in the U.S. without a prescription.”
Patrizia Cavazzoni, M.D., the director of the FDA’s Center for Drug Evaluation and Research, elaborated on the product. “When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy.”
As for when you can begin purchasing Opill, the FDA confirmed that any announcements on this from will be announced by the manufacturer.
Stay tuned for our expert interview detailing what this could mean for your sexual wellness routine.
For more on sexual wellness, TikTok’s “Kitty Cocktails” are f-cking your vagina — and not in a good way.