Adam Urato, who is currently a vaccine advisor to the CDC, is closely associated with acting CDER director Tracy Beth Høeg and is a fellow skeptic of the use of selective serotonin reuptake inhibitors during pregnancy.
Tracy Beth Høeg, acting director of the FDA’s Center for Drugs Evaluation and Research, is reportedly looking to onboard a health expert who shares her skepticism toward the use of antidepressants during pregnancy.
Citing anonymous sources familiar with the matter, The Associated Press on Wednesday reported that Høeg is looking to hire Adam Urato, a specialist in maternal and fetal medicine, as a full-time FDA employee. Urato has appeared in several interviews and seminars in recent months to speak about the risks of using selective serotonin reuptake inhibitors (SSRIs) during pregnancy and their potential to cause harm to the infant.
Urato, who currently serves as a panelist on the CDC’s Advisory Committee on Immunization Practices, is also a friend of Høeg’s, according to The AP. He was named as a member if the committee in January.
On an FDA panel about SSRI safety in pregnancy in July 2025, Urato called for stronger warnings on the drugs. “Never before in human history have we chemically altered developing babies like this,” he said during the meeting, according to reporting from The New York Times. “This is happening without any real public warning, and that must end.”
Outside experts blasted the meeting. “They didn’t want any nuance,” Diana Zuckerman, president of the nonprofit National Center for Health Research, told BioSpace in September of the SSRI panel as well as one held a week earlier on menopause and hormone replacement therapy. “It seemed they didn’t want any real difference of opinion.”
Similarly, Steven Fleischman, president of the American College of Obstetricians and Gynecologists, said in a statement at the time that the panel was “alarmingly unbalanced,” adding that there is “robust evidence” to support the safety and efficacy of SSRIs in pregnancy.
“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,” he added.
Urato has also filed a citizen petition with the FDA to add a boxed warning to SSRIs, flagging patients and prescribers to the supposed risk of complications during pregnancy and adverse effects on fetal brain development.
Høeg, according to The AP’s anonymous sources, has made the review of this petition a priority, even regularly consulting with Urato on the matter. Many inside the agency consider the relationship between the two to be a conflict of interest, but instead of removing herself from the petition process, Høeg appears to be working to speed it up, the publication reported.
“I am friendly with her,” Urato told The AP in an email on Wednesday, however insisting that they “do not have a longstanding personal friendship that would in any way prevent her from reviewing the citizen petition.” Urato also called Høeg an “excellent scientist.” The Department of Health and Human Services told the publication it would settle matters of Urato’s petition with him directly.
Høeg, who was previously an aide to FDA Commissioner Marty Makary, was named acting director of CDER in December 2025, following the retirement of cancer stalwart Richard Pazdur. Last month, Høeg announced a probe into the safety of using antidepressants in pregnancy and of antibodies used to immunize children against the respiratory syncytial virus. “We really haven’t been doing sort of thorough safety monitoring of these products,” she said at the time.
