FDA panel recommendation against pre-term drug highlights dearth of options
A Food and Drug Administration advisory panel's recommendation to pull a treatment for preventing pre-term births from the market leaves one fewer option for a health care segment that's customarily overlooked researchers and drugmakers.
Why it matters: Treatments to reduce maternal mortality or reduce pre-term births — problems that disproportionately impact women of color — are few and far between. And experts say there isn't much energy directed at building a pipeline.
What they are saying: "There is a dearth of research into women's health, into peripartum and immediate postpartum health and there's a dearth of good high-quality preventative treatments," Megan Ranney, academic dean at the Brown University School of Public Health, told Axios.
- "Although the removal of this product makes absolute sense, it leaves those at highest risk with even fewer options," she said.
Some context: Women's health has been chronically underfunded and under-researched — and that is a costly mistake, writes Chloe Byrd, an adjunct sociologist at the Rand Corporation.
- The U.S. consistently ranks among the lowest industrial countries when it comes to maternal mortality, infant deaths and racial disparities.
- "Frankly by any measure, we're doing a pretty poor job whether that be maternal mortality and morbidity or the very clear disparities that exist," said Adrianne Nickerson, CEO and co-founder of Oula, a maternity care company that combines midwifery with obstetrics care said.
- "It's a reflection of how little investment has been made in this space despite the fact there is such a huge human cost to this and, frankly, moral imperative. It's a shame we're in the space that when one drug goes off the market it feels like it's the only thing that's out there," Nickerson said.
Some of this stems from a 1977 FDA policy banning most women of "childbearing potential" from participating in clinical research studies. That policy wasn't formally rescinded until 1993.
- Even today, few drugs are tested in pregnant women, and there's a greater barrier to drug development for pregnant women because it's seen as too risky, Ranney said.
- "There's this question of 'How do you incentivize commercialization of these products?'" Ranney said. "It's far easier to create wellness products because, God forbid, no one wants to cause harm to a pregnant woman or a fetus.''
Between the lines: There's a racial equity issue, as well as a gender equity one, at the heart of this, experts say.
- "One of the issues here that's worth calling out explicitly is there is a higher rate of pre-term birth, stillbirth and poor maternal outcomes among Black and Hispanic women and among low-income women," Ranney said. "It's another place in health care where we are propagating inequities."
What to watch: Already, there are a growing number of women's health startups focused on scaling evidence-based, but non-pharmacological interventions like Oula, Nickerson said.
- In the wake of the overturn of Roe v. Wade, there's also been an uptick in investment interest in women's health as well, Axios' Sarah Pringle reported earlier this year.