Tracy Beth Høeg, the acting director of the FDA’s Center for Drug Evaluation and Research (CDER), is reportedly seeking to hire Adam Urato, a maternal and fetal medicine specialist known for his critical stance on antidepressant use during pregnancy. According to anonymous sources cited by The Associated Press, Høeg aims to bring Urato on as a full-time FDA employee.
Urato has been vocal in public forums about potential risks associated with selective serotonin reuptake inhibitors (SSRIs) when used by pregnant women. He currently serves as a panelist on the CDC’s Advisory Committee on Immunization Practices, having joined in January. In July 2025, during an FDA panel focused on SSRI safety in pregnancy, Urato advocated for stronger warnings about these drugs. “Never before in human history have we chemically altered developing babies like this,” he said at the meeting, according to The New York Times. “This is happening without any real public warning, and that must end.”
Recent FDA expert panels addressing SSRI use during pregnancy and hormone replacement therapy have faced criticism over perceived lack of balance. Diana Zuckerman, president of the National Center for Health Research, told BioSpace in September that these meetings seemed designed to avoid nuanced debate: “They didn’t want any nuance,” she said of both the SSRI panel and one held earlier on menopause therapies. “It seemed they didn’t want any real difference of opinion.”
Steven Fleischman, president of the American College of Obstetricians and Gynecologists, also criticized the SSRI panel as being “alarmingly unbalanced.” He stated there is “robust evidence” supporting SSRIs’ safety and efficacy during pregnancy. Fleischman emphasized that untreated depression in pregnancy can lead to substance use, preterm birth, preeclampsia, low birth weight, impaired attachment between mother and infant, limited engagement with medical care or self-care, and even suicide.
Urato has filed a citizen petition with the FDA calling for boxed warnings on SSRIs regarding possible complications during pregnancy and effects on fetal brain development. Sources told The AP that Høeg has prioritized reviewing this petition and frequently consults with Urato about it—a relationship some within the agency view as a conflict of interest. Rather than recusing herself from handling the petition process due to their association, Høeg is reportedly working to expedite its review.
“I am friendly with her,” Urato wrote in an email to The AP but insisted their relationship would not affect her ability to review his petition impartially: they “do not have a longstanding personal friendship that would in any way prevent her from reviewing the citizen petition.” He described Høeg as an “excellent scientist.” The Department of Health and Human Services indicated it would address matters related to Urato’s petition directly with him.
Høeg was named acting director of CDER in December 2025 after serving as an aide to FDA Commissioner Marty Makary; she succeeded Richard Pazdur following his retirement. Last month she announced investigations into both antidepressant safety during pregnancy and antibody treatments for respiratory syncytial virus immunization in children. At that time she stated: “We really haven’t been doing sort of thorough safety monitoring of these products.”
