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Apr 12, 2024

How Two FDA Moves Have Quietly Advanced Reproductive Health Care

The decisions mirror momentum in telehealth and beyond to make reproductive health care more accessible. This summer, the US Food and Drug Administration made two decisions that reflect a demand for

The decisions mirror momentum in telehealth and beyond to make reproductive health care more accessible.

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.

Read more: Clinical Trials Are Now at Your Local Drugstore. What That Means for You

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 and the Bloomberg School of Public Health, 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.

"The data has kind of been piling up over the decades for this," Burke said.

Pills like Opill that don't contain estrogen have mostly been prescribed to people who smoke cigarettes, those who are breastfeeding, people who are over age 35 and anyone else who might be more vulnerable to the potential side effects of added estrogen. Progesterone-only pills are also used by trans men in hormone therapy.

Speaking of the risk with combined pills, some of which will likely follow in Opill's over-the-counter footsteps, Burke says she's careful not to dismiss patients' fears about any medication risk. But as an absolute number, Burke says this risk is low and that pregnancy presents a higher risk of clots.

Telemedicine has already made many common medications, including birth control, more accessible for many people. Through the pandemic and beyond, there's been a growing dependency on telemedicine -- a boom of do-it-from-your-laptop type health care useful for people with minor health conditions or a prescription they've had for years. Many dollars of this are spent on so-called femtech, which is growing but underutilized compared to the level of interest people have in its services, according to a market survey by FemTech Analytics.

In terms of birth control and emergency contraception (including Plan B, which does not require a prescription), getting virtually prescribed could help remove stigma and other barriers, and telehealth makes it possible for things to be more easily shipped directly to your door. Other medications in the sexual health sphere, like PrEP for HIV prevention, which requires a prescription, are also available online.

But the role of increased choice in telemedicine websites becomes less clear when you consider the other reasons people may be skirting around the traditional brick-and-mortar model of health care.

"Individuals are becoming much more participatory in their health care for a number of reasons," said Lindsay Allen, a health economist and health services researcher at Northwestern University. One of those reasons is the sky-high cost of health insurance, which often include high-deductible plans. While a higher deductible means a lower monthly premium, which Allen describes as the "luxury of eventually having health insurance," it means more shopping around for cheaper rates until you hit that magic deductible. And finding a doctor online is often a cheaper option.

"What telehealth has done is kind of forced or allowed us to reexamine our understanding of what needs to actually take place in a doctor's office, and more generally under a doctor's purview," Allen said.

Another reason people are taking health issues into their own hands may be the volume of discussions about it on social media.

"We cannot overstate the role of TikTok," Allen said. She noted the wave of people seeking treatment or diagnosis of ADHD, in response to content they see online suggesting they may have the disorder.

Another type of content you can find on TikTok are parents documenting their birth experiences and experiences as new mothers. For many new parents, the transition can be clouded by postpartum depression.

The FDA this month approved Zurzuvae, the first pill to be specifically prescribed to treat postpartum depression, or PPD. Often with limited support and the stress of a new baby, people with PPD have suffered in the dark with options limited to "traditional" depression therapy, which may be helpful but can also miss the mark of what causes PPD in the first place.

After birth, hormone levels drop dramatically after being at an all-time high during pregnancy. In part, Zurzuvae works to soften the impact of the dramatic drop in hormones people experience after giving birth. The current thinking behind the reason for PPD is that some people are more sensitive to the effects of hormone levels than others, and finding a medication that specifically targets this drop, in addition to working more quickly than traditional antidepressants, is "revolutionary," according to Dr. Sarah Oreck, a reproductive psychiatrist with Mavida Health.

"The gold standard right now for the treatment of severe postpartum depression is therapy in combination with SSRIs, which can take four to 12 weeks to even start working," Oreck said.

Beyond its work for PPD as a metabolite of progesterone, Zurzuvae is a neuroactive steroid GABA-A receptor positive modulator -- an alphabet soup way of saying that it works through GABA neurotransmitters instead of serotonin, like the SSRIs many people are familiar with. On targeting serotonin: "We know depression is much more complex than that," Oreck said, adding that research has found differences in GABA neurotransmission among patients who have died by suicide, and that research continues to challenge the idea of serotonin depletion as the single cause of depression.

Zurzuvae was tested in adults with depression as well, Oreck said, but it wasn't found to be as effective as in those with PPD. The pill was approved for people with postpartum depression, defined as a major depressive episode that usually occurs after childbirth but can begin in late pregnancy, and will be available in the last three months of this year, according to the manufacturer. Still, there's no final word on how much it will cost yet. The only other medication designed to treat it is an IV drip that costs more than $30,000.

Despite Oreck's gratitude for a new PPD pill as an option for people struggling with severe depression after birth, she worries that in some circumstances it may cloud the other, very real contributors to postpartum depression, such as domestic abuse, lack of resources and more problems that many new parents face but no medication can fix.

"We live in a culture that tends to like to take medications and have quick fixes, so I do worry that that's a little bit of where we would go with this instead of trying to look at all the contextual issues," Oreck noted.

As far as an OTC birth control pill is concerned, it does remove the need for an additional doctor's visit (and cost), but there's also no word for how much the new pill will cost, or if there will be the same barriers Plan B faces in-store (like being locked up in a case). But as Shachar notes, the reach of telemedicine websites like HeyJane, which deliver things like birth control, UTI medications and abortion pills where state regulation allows, have expanded.

But getting abortion pills online in states where it's illegal brings up the issue of a "digital 'bread crumb trail,'" Shachar said.

"Femtech also has some areas of concern for users," she said, adding that the Federal Trade Commission has started enforcing its health data privacy rules against certain fertility apps, which are used to track the menstrual cycle.

We also need to look at the way telehealth, while expanding access for many people, is not equally accessible, according to Allen, who's conducting research on telemedicine and marginalized communities. We can expect both Zurzuvae and an OTC birth control pill to pop up on telemedicine sites, but if people can't afford the medication or don't have reliable internet access to order online, it becomes a moot point.

"Telehealth has been seen as this amazing way to cut costs on the health care side of things, and it's also been seen as this way to improve access on the patient side of things," Allen said. "We need to challenge both of those thoughts."

As discussions around reproductive and sexual health continue online, and marketers follow with new ways of branding femtech, people's demands for accurate health information and resources will continue to grow. Medical regulators like the FDA have big shoes to fill.

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