FDA’s Top Drug Regulator To Probe Safety of Antidepressants, RSV Antibodies

 

Tracy Beth Høeg addressed FDA staffers for the first time in her role as the fifth CDER chief under President Donald Trump, announcing inquiries into the use of SSRIs in pregnancy and RSV antibodies in infants despite well-documented safety of these treatments.

Tracy Beth Høeg, acting director of the FDA’s Center for Drug Evaluation and Research, has announced plans to look into the safety of antidepressants and the antibodies used to immunize infants against respiratory syncytial virus infection.

“I’ve been interested to learn we really haven’t been doing sort of thorough safety monitoring of these products during pregnancy, and so I think we could do a better job,” Høeg told FDA staff, according to Thursday reporting from STAT News, which obtained a recording of her first address as the top drug regulator.

Formerly FDA Commissioner Marty Makary’s aide, Høeg took the reins at CDER in December 2025 following the abrupt retirement of longtime FDA veteran Richard Pazdur. She is the fifth person to head the division under the second Trump administration.

In speaking with her staff this week, Høeg highlighted her interest in women’s health, particularly during pregnancy, and said that there was a need to conduct more randomized studies in this population. As part of this push, she will scrutinize a drug class called selective serotonin reuptake inhibitors (SSRI), which are commonly used as first-line treatments for depression, anxiety disorders and other mental health conditions.

An FDA expert panel led by Høeg and Makary in July 2025 outlined the risks of using SSRIs during pregnancy, noting the potential for birth defects. However, professional organizations like the American Psychiatric Association and the American College of Obstetricians and Gynecologists blasted the panel, underscoring the importance of SSRIs as a tool to control mental health problems that pregnant women commonly endure.

Steven Fleischman, ACOG president, called the panel “alarmingly unbalanced” in a statement at the time, arguing that “robust evidence has shown that SSRIs are safe in pregnancy and that most do not increase the risk of birth defects.”

Fleischman added that “untreated depression in pregnancy can put our patients at risk for substance use, preterm birth, preeclampsia, limited engagement in medical care and self-care, low birth weight, impaired attachment with their infant, and even suicide.”

Aside from SSRIs, Høeg on Thursday also said that she would be looking into the use of monoclonal antibodies in infants to protect against respiratory syncytial virus (RSV). Currently, there are two such therapies on the market: Sanofi and AstraZeneca’s Beyfortus and Merck’s Enflonsia.

The safety probe on RSV antibodies was first reported in December 2025. At the time, senior executives at these pharma companies were informed that a safety investigation was ongoing, though it wasn’t clear what information the FDA needed from them.

In her address on Thursday, Høeg said that “potential increased risk of seizures, febrile seizures, due to the RSV monoclonal antibodies is something else that we’re looking at,” according to STAT. The CDC itself found no such increased seizure risk in a June 2025 report.

https://www.biospace.com/fda/fdas-top-drug-regulator-to-probe-safety-of-antidepressants-rsv-antibodies