FDA Drug Official Seeks to Hire Friend Pushing Antidepressant Warning
The Food and Drug Administration is currently reviewing a controversial request for new warnings on antidepressant medications, a process that has revealed an unusual conflict of interest situation within the agency. According to information obtained by The Associated Press, Dr. Tracy Beth Hoeg, the FDA's top drug regulator, is actively working to hire Dr. Adam Urato, a researcher and personal friend who is petitioning for these very warnings.
Proposed Boxed Warning for SSRIs
Dr. Adam Urato, a maternal-fetal medicine specialist and known critic of antidepressant safety, has formally petitioned the FDA to add a boxed warning to selective serotonin reuptake inhibitors (SSRIs). These medications represent the most commonly prescribed drugs for depression worldwide, including well-known brands like Prozac, Paxil, and Zoloft along with their generic equivalents.
Urato's petition claims that SSRIs can cause significant pregnancy complications, including miscarriages and fetal brain abnormalities that might potentially lead to autism spectrum disorders and other developmental conditions in children. This proposed labeling change has become a top priority for Dr. Hoeg, who regularly consults with Urato and is working to bring him on as a full-time FDA employee, according to multiple sources familiar with the situation.
Conflict of Interest Concerns
Within FDA circles, Hoeg's close relationship with Urato is viewed as a clear conflict of interest that would normally require her recusal from any work related to the petition under standard agency protocols. However, sources indicate that Hoeg is actively working to accelerate the agency's review of her friend's proposal rather than distancing herself from the process.
"A black box warning is a big red flag with both practitioners and patients," explained Dr. Jennifer Payne, a reproductive psychiatrist at the University of Virginia. "What's missing in this petition is an understanding of the risks of maternal mental illness during pregnancy, not just to the woman, but to the pregnancy and ultimately the infant."
Outside medical experts have raised serious concerns about the petition's scientific foundation, noting it relies on what they describe as flimsy data including animal studies and small human trials. These experts worry that an FDA warning based on such evidence could cause pregnant women to stop necessary medication, potentially leading to serious health risks from untreated depression.
Questionable Presentation of Work
Last fall, Dr. Hoeg gave a presentation on the SSRI petition to top FDA drug officials, presenting the work as her own. Staffers who reviewed her slides discovered they had actually been created by Dr. Urato, according to sources who spoke to AP. This incident was first reported by Stat News and adds to concerns about the relationship between the two medical professionals.
In response to inquiries, Urato stated in an email that Hoeg is "an excellent scientist" and that they have known each other for several years. He added, "I am friendly with her, as I am with many colleagues, but we do not have a longstanding personal friendship that would in any way prevent her from reviewing the citizen petition."
Background of Controversial Figures
The antidepressant review represents just the latest in a series of controversial topics taken up by Dr. Hoeg, a sports medicine physician with no previous government or management experience before her appointment. During the COVID-19 pandemic, Hoeg gained attention as a critic of masking, vaccine mandates, and other public health measures.
She co-wrote papers with medical contrarians who would later join the Trump administration, including FDA Commissioner Marty Makary and FDA's vaccine chief, Dr. Vinay Prasad. All three have become top surrogates for Health Secretary Robert F. Kennedy Jr., who has reshaped health agencies to include more anti-vaccine voices.
In January, Urato was named to the Centers for Disease Control and Prevention's panel on vaccine recommendations, which has been completely reshaped by Kennedy to include numerous anti-vaccine perspectives. Like many vaccine critics, including Kennedy, Hoeg has also expressed skepticism about antidepressants, questioning both their safety and benefits.
Unusual Public Commentary
FDA officials typically avoid making public comments about matters under review to prevent the appearance that decisions are based on individual opinions rather than scientific evidence. However, Hoeg has taken a hands-on approach to the SSRI petition, telling FDA staffers that their proposed nine-month review timeline needed to be shortened, according to sources familiar with internal discussions.
Last July, she hosted a panel of outside experts at the FDA on SSRIs that included Urato and nine other critics of the drugs. "Never before in human history have we chemically altered developing babies like this, especially the developing fetal brain, and this is happening without any real public warning," Urato declared at that meeting.
Shortly afterward on a podcast, Hoeg echoed many of Urato's points, stating, "I think women should be informed about the potential risks so that they have time to come off SSRIs if they want to when they're trying to get pregnant."
Complex Safety Considerations
The safety of antidepressants has been scrutinized for decades, leading to several updates to their FDA labels, including the addition of a black box warning about the risk of suicidal behavior in children. For pregnant women, current labels already list documented safety issues, including risks of excess bleeding after giving birth.
Medical professionals who treat women with depression emphasize that they discuss these risks with patients, carefully balancing possible medication side effects against the potential harms of relapsing into depression, which can include self-harm, substance abuse, and other behaviors negatively impacting both women and fetuses.
Researchers who have reviewed Urato's SSRI petition note that many studies claiming to show connections to disorders like autism fail to account for other important health factors. Women with depression typically have higher rates of smoking, diabetes, and family histories of mental illness—all factors that can independently increase the likelihood of developmental disorders.
"So how do we say that these outcomes are a result of the SSRI when all of these other factors are at play?" asked Dr. Amritha Bhat, a University of Washington perinatal psychiatrist. Bhat and other researchers support more investigation into SSRI effects while acknowledging they acknowledge possible downsides to medication use.
"But in the meantime we need to provide options to people that are struggling with these symptoms during pregnancy," she emphasized. "We cannot just ask them to white knuckle their way through it."
Agency in Transition
Dr. Hoeg was appointed to lead FDA's drug center in December, inheriting the position during a period of unprecedented upheaval that has included layoffs, buyouts, and multiple leadership changes. She represents the sixth person to lead the 5,000-person center within the past year alone.
Staffers did not hear from Hoeg directly until a town hall meeting last month, where she voiced concerns about the safety of both SSRIs and injectable RSV shots for children—another class of drugs the FDA is reviewing at her request. Respiratory syncytial virus sends thousands of American children to hospitals annually.
A spokesman for the Department of Health and Human Services, which oversees the FDA, stated that the agency would respond directly to Urato about his petition. The situation continues to develop as the FDA navigates complex scientific questions amid personnel relationships that have raised ethical concerns among agency insiders and external observers alike.
