By Lara McCormick, Honeycomb Contributor
It can be really hard to get oral contraceptive pills. Personally, I’ve been struggling lately to update my prescription and have been jumping through multiple hoops at the pharmacy to actually get the prescription I got from a doctor. I know I’m not alone; 30% of women ages 18-44 reported issues getting their prescription contraceptive pills in 2016. There have been so many times I’ve wished I could just buy a pack of birth control pills over-the-counter like I get a bottle of Advil. Stressing about if I’ll be able to get my pills each month makes me feel like I have less control over my reproductive health.
FDA moves forward with HRA Pharma application
Oral contraceptive pills have not been approved by the Food and Drug Administration (FDA) for over-the-counter use, but there is hope on the horizon! Currently, contraceptive pills are FDA approved as prescription only and require a doctor’s approval before a patient can receive the medication. The issue has been politicized in the past and is often discussed with other conservative issues that restrict reproductive health choice. The politicization of the issue made it unfavorable for the FDA to consider an application for over-the-counter contraceptive pills despite facts and studies saying the pills would be safe for use.
HRA Pharma, a French company, has put in an application to the FDA for over-the-counter approval for their mini pill, Opill. The mini pill is a progesterone-only oral contraceptive that would be available without a prescription. A progesterone-only pill has a lower risk of blood clots, commonly caused by combination pills with estrogen, but is less common than combination pills that are currently prescribed to most Americans. Progesterone-only pills do require a stricter schedule because they are more reactive to missing or delaying pills.
The US is falling behind international trends
This idea isn’t a new trend. The American College of Obstetricians and Gynecologists, a leading organization guiding care in reproductive health, has been advocating for over-the-counter contraceptive pills since 2012. Countries throughout Europe and Latin America have already approved over-the-counter pills, the United Kingdom just approved the HRA Pharma pill last year. Based on the success of over-the-counter pills in other countries, we know the pills are safe and effective with minimal risk of side effects. After taking into account the imperfect and human use of the mini pill, it is still 91% effective. Patients have similar rates of continuing pill usage over time whether they use the over-the-counter version or prescription. Additionally, menstruating people have been shown to accurately self-screen themselves for eligibility and medical concerns related to taking the pill. Over-the-counter pills could increase access to contraceptive pills, especially for people of color, young people, LGBTQIA people, and people with low incomes who more often report problems accessing this healthcare due to insurance issues, finding clinics, or not having a regular physician.
Seems like an easy choice… the mini pill is safe, effective, and allows for greater control of reproductive health. Some critics have voiced concern that by removing the prescription requirement for oral contraceptives, fewer people would go to a physician’s office where they receive pap smears, pelvic exams, and STI testing. These tests have sometimes been used to deny access to oral contraceptives even though they are not medically necessary to start or continue use. Studies have shown people were just as likely to receive preventive screenings like pap smears if they get their oral contraceptives over-the-counter.
What’s the timeline for approval?
There’s still a way to go before the FDA application is approved for the mini pill. The decision will take roughly 9-10 months and HRA Pharma needs to prove patients can screen themselves for eligibility for the pill and take it correctly without doctor instruction. Luckily, most of this research and proof already exists.
What’s still unknown about the mini pill is how much it's going to cost. Currently, with a prescription, many people do not pay out-of-pocket for their pills due to changes made in the Affordable Care Act. One study found most menstruating people are willing to pay up to $20 for a pack of pills. The mini pill in the United Kingdom is roughly £10 (about $12) for one pack and is available in a pack of three.
I know I’ll be waiting patiently for FDA approval!Having over the counter access to oral contraceptives would be a big win for reproductive freedom during a time when options are becoming limited for many people. But until then, I’ll keep frantically calling my pharmacy to refill my prescription on time.