CDER’s Hoeg has SSRIs, mAbs in Crosshairs
CDER acting director Tracy Beth Hoeg is preparing new safety reviews of widely used antidepressants and monoclonal antibodies for respiratory syncytial virus (RSV), setting up fresh tensions with major medical societies and manufacturers over products many clinicians consider well established.
In her first address to staff as acting director, Hoeg says she plans to scrutinize the use of selective serotonin reuptake inhibitors (SSRIs) in pregnancy and RSV antibodies in infants, arguing that current postmarketing surveillance has not been thorough enough in these populations, according to Biospace coverage of a STAT article.
FDA commissioner Marty Makary named physician–epidemiologist Hoeg as CDER acting chief in December, replacing then-director Richard Pazdur (see story). Hoeg’s selection had raised concern with public health experts because of her past criticism of Covid-19 policies and vaccines. She previously questioned aspects of U.S. Covid-19 policy, including certain childhood vaccination mandates and mask or mitigation strategies for children.
“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 staff, according to a recording of the meeting obtained by STAT. She noted a broader push to expand randomized studies in pregnant women and framed the new work as part of a focus on women’s health during pregnancy.
SSRIs have already been the subject of an FDA expert panel led by Hoeg and Makary last 2025. That panel highlighted potential risks of birth defects with SSRI exposure in pregnancy, but drew strong pushback from professional groups including the American Psychiatric Association and the American College of Obstetricians and Gynecologists (ACOG), which argued the discussion underplayed the harms of undertreated maternal depression. ACOG president Steven Fleischman called the panel “alarmingly unbalanced” and pointed to what he described as robust evidence that most SSRIs do not increase the risk of birth defects, while warning that untreated depression in pregnancy raises risks of substance use, preterm birth, preeclampsia, poor engagement in care, low birth weight, impaired infant bonding and even suicide.
Hoeg also confirmed to employees that CDER is moving ahead with a previously disclosed safety probe of monoclonal antibodies used to prevent RSV in infants. The investigation was first reported in December, when senior executives at the three companies were notified that FDA was reviewing the products, though the agency has not detailed what additional data it is seeking or what regulatory actions might follow. In her comments to staff, Høeg said that a “potential increased risk of seizures, febrile seizures, due to the RSV monoclonal antibodies is something else that we’re looking at,” even as the CDC reported 6/2025 that it had not detected an elevated seizure signal with these agents.