This summer, the US Food and Drug Administration made two decisions that reflect a demand for more access to reproductive health care. In July, it was the over-the-counter ruling of Opill, the first birth control pill to be sold without prescription in the US. This month, it was the approval of Zurzuvae, the first pill specifically made to treat postpartum depression.
In the eyes of many experts in medicine, federal moves like these have been a long time coming. A years-long effort has been in the works, for example, to remove the prescription requirement (and doctor’s visit) for a contraceptive pill millions of people already use.
Carmel Shachar, faculty director of Harvard Law School’s Health Law and Policy Clinic, said that while the FDA’s review process for drugs is designed not to “blow in the political winds,” some pressure from the Biden administration to increase reproductive health care access has been mounting since the overturn of Roe v. Wade. (The court battle over mifepristone, the first of two drugs used in a medication abortion, continues.) President Joe Biden in late June issued his third executive order on reproductive health care, directing agencies like the Department of Health and Human Services to increase access to over-the-counter contraception.
This increased focus on reproductive health, combined with the medical community’s general stance, may have provided the right cushion for these two FDA decisions to fall into.
“Did the political pressures help amplify the voices of experts who agreed that OTC birth control was safe and patient advocates who articulated a need for these treatments?” Shachar asked. “Likely so.”
The federal government peeling back some of its red tape around birth control and postpartum care also mirrors demands from regular people for reproductive care to receive the same attention as other areas of health. For example, during the COVID pandemic, millions learned that the vaccines’ side effects on the menstrual cycle (found to be small, safe and temporary) weren’t one of the many details scientists combed through before they began delivering vaccines to the masses, contributing to misinformation and broader distrust in medicine.
In the US, starting in 1973 and lasting about 20 years, people of “childbearing potential” were excluded from drug trials all together, leaving room for more guesswork when it came to doses that weren’t for mostly white men. In addition to no data collection on menstruation, most vaccine trials during the pandemic excluded people who were breastfeeding or pregnant.
More Americans appear to be addressing the gap between what’s currently available and what they want their reproductive health care to look like. People on social media are talking openly about their experiences postpartum, problems with birth control and more, while the business world hones in on people’s interest in different solutions by marketing consumer products (not all of them are good) and telehealth options operating under the umbrella of “femtech.”
Sometimes, the demand from the ground aligns with medical regulation. For example, when the FDA approved Natural Cycles, a temperature-based cycle tracking app, to be marketed as a birth control method in 2018, Dr. Terri Cornelison, assistant director for the health of women in the FDA’s Center for Devices and Radiological Health, called the move a response to the way people are “increasingly using digital health technologies to inform their everyday health decisions.”
Here’s a look at how the two recent reproductive health decisions from the FDA represent something bigger.
A birth control pill you don’t need a prescription for
Opill is the name of the first over-the-counter birth control pill, and it’s expected to become available early next year. It’s a progesterone-only pill, which is a family of “mini pills” less popular than so-called “combination” birth control pills that also contain estrogen. Pills like Opill that contain just the one hormone have more finicky instructions on when you need to take them, which make them a little less effective at preventing pregnancy than most brands of pills on the market.
But it’s a start. Dr. Anne Burke, associate professor in the Johns Hopkins Medicine Department of Gynecology and Obstetrics, said Opill being available without prescription will likely be the “first of many as opposed to a one-off.”
Burke, who is also a member of the coalition of the Free the Pill movement to make birth control more accessible, and signer of the group’s statement of purpose, said that the FDA lagged behind medical organizations like the American College of Obstetricians and Gynecologists and the American Academy of Pediatrics, who’ve decided that the benefits of over-the-counter birth control pills far outweigh the risks.