Joy Burkhard’s Remarks on Behalf of 2020 Mom

OWH Office on Women’s Health FDA U.S. Food & Drug Administration Listening Session

By Joy Burkhard, MBA
Founder and Executive Director, 2020 Mom

On May 5, 2022, several organizations, including 2020 Mom, were invited to join the National Consumers League in sharing their work and the U.S. Food and Drug Administration (FDA)-related priorities. Here are Joy Burkhard’s remarks:

Good afternoon. My name is Joy Burkhard, I am the founder and executive director of 2020 Mom. We are a 10-year-old national non-profit organization with offices in L.A. and D.C., whose mission is to close gaps in maternal mental health care.

I also previously worked at a Fortune 50 insurance company for 24 years and am very interested in scaling treatment guidelines and adopting evidence-based treatments more quickly in our health delivery system.

You may know that this week is maternal mental health awareness week, and though more awareness and attention is starting to be paid to the mental health and wellbeing of women during pregnancy and the postpartum period, we have only begun to scratch the surface at government, corporate, clinical and societal levels.

Maternal Mental Health Disorders impact up to 1 in 5 women on average. These rates double for Black women and are also substantially increased for our indigenous sisters. The COVID pandemic also nearly doubled the rates at the height of lock-down. A common myth is that maternal mental health disorders equal postpartum depression. However, there is a range of disorders, like maternal OCD, general anxiety, and birth trauma/PTSD. The onset of most of these disorders happens almost as frequently in pregnancy as in the postpartum period and women can be suffering from untreated depression and anxiety before they become pregnant.

Postpartum depression alone, is the most common complication of pregnancy.

As if these numbers weren’t disturbing enough, the greatest concern, and the focus of our work at 2020 Mom, is that most women are never screened, diagnosed, or treated for these disorders. One study illustrated just 15% of women received treatment. Untreated MMH disorders wreak havoc on women and their health, family stability, infant and newborn health, and mental health.

We believe that the maternal medical home - the obstetrician/midwife - should be screening for maternal mental health disorders starting in early pregnancy. This is consistent with the American College of Obstetrics and Gynecology recommendations, yet screening rates remain low. The most significant barrier is the lack of treatment/referral options. Right now, OBs find their options are to offer a prescription (which some still don’t feel comfortable with for fear of harming the unborn or breastfeeding baby), recommend a mental health practitioner (knowing it could take 6-8 weeks and a grueling journey searching for a provider in her insurance network or even one she pays to see out of pocket), or send her to the ER where a psychiatrist may be able to see her within 48 hours.

It is critical that OBs and families have more treatment options, which the FDA is in a unique position to assist with. (For example, fast-tracking promising novel treatments like digital therapeutics -apps/gaming that are evidence-based and can be prescribed by clinicians like OBs and treatments like Brexanalone, currently the only drug treatment available for maternal depression, available now as infusion therapy).

We also ask you to consider the role the FDA could play in advancing the adoption of these treatments. The Agency for Healthcare Research and Quality (AHRQ), has noted it takes roughly seventeen years to widely adopt clinical practice guidelines/evidence-based medicine in the U.S.

For example, the FDA could play a role in insurer formulary development and step therapy protocols. We advocated for a woman who was suffering from postpartum depression with a well-documented history of significant adverse reactions to certain psychiatric meds to receive access to Brexanalone. She was required to try 3 other drugs first and electroconvulsive therapy (ECT) all before 6 months postpartum – it simply wasn’t possible. These types of step therapy protocols are unreasonable and vary by insurer.

Finally, safe and easy to access birth control, including prescribed apps for period tracking and male contraception to prevent unplanned pregnancies should be a priority given that unplanned pregnancies put women at higher risk of maternal mental health disorders.

Thank you for your attention – we recognize just how important the role you play is in addressing maternal and maternal mental health.