Tracy Beth Høeg, acting director of the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER), has announced that the agency will examine the safety of antidepressants and monoclonal antibodies used to immunize infants against respiratory syncytial virus (RSV).
“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 reporting from STAT News, which obtained a recording of her first address as CDER director.
Høeg assumed leadership at CDER in December 2025 after the retirement of Richard Pazdur. She is the fifth person to lead the division under the current administration. In her remarks to staff, Høeg emphasized a focus on women’s health during pregnancy and called for more randomized studies involving this population. She said she would closely review selective serotonin reuptake inhibitors (SSRIs), which are widely prescribed for depression and anxiety.
An FDA expert panel led by Høeg and former commissioner Marty Makary in July 2025 highlighted risks associated with SSRI use during pregnancy, including potential birth defects. However, organizations such as the American Psychiatric Association and the American College of Obstetricians and Gynecologists criticized the panel’s findings. According to Steven Fleischman, president of ACOG, “robust evidence has shown that SSRIs are safe in pregnancy and that most do not increase the risk of birth defects.” Fleischman also stated 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.”
Høeg also addressed concerns about monoclonal antibodies given to infants for RSV prevention. Two therapies—Sanofi and AstraZeneca’s Beyfortus and Merck’s Enflonsia—are currently available. The FDA began its safety investigation into these products in December 2025; senior executives at involved pharmaceutical companies were notified at that time.
In her Thursday address, Høeg noted: “potential increased risk of seizures, febrile seizures, due to the RSV monoclonal antibodies is something else that we’re looking at,” according to STAT News. However, a June 2025 report from the Centers for Disease Control and Prevention found no increased seizure risk linked to these treatments.
Recent FDA expert panels on SSRIs during pregnancy have faced criticism for lacking balance or representing only one perspective. Some leaders have argued that such panels may be designed to reach predetermined conclusions rather than encourage open scientific debate (https://www.biospace.com/article/fda-expert-panels-lack-balance-in-pursuit-of-gold-standard-science/).
The outcome of these ongoing investigations remains unclear as regulatory action has not yet been specified (https://www.biospace.com/article/fda-launches-probe-into-safety-of-approved-anti-rsv-antibodies/).
