FDA's Top Drug Regulator Faces Conflict of Interest Over Antidepressant Warnings

Dr. Tracy Beth Hoeg is working to hire a researcher who wants the FDA to add new pregnancy risk warnings to antidepressants, despite concerns from outside experts.

Published on Mar. 4, 2026

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The Food and Drug Administration's top drug regulator, Dr. Tracy Beth Hoeg, is working to hire a researcher and friend, Dr. Adam Urato, who wants the agency to add new warnings to antidepressants about unproven pregnancy risks. Urato's petition says the medications can cause pregnancy complications, including miscarriages and fetal brain abnormalities that may lead to autism and other disorders in children. However, outside experts say the petition relies on flimsy data and fear a new FDA warning could cause pregnant women to stop medication unnecessarily, leading to serious health risks from untreated depression.

Why it matters

This case highlights a potential conflict of interest, as Hoeg's close relationship with Urato is viewed by some within the agency as a clear conflict that would normally result in her recusing herself from any work on the petition. However, Hoeg is actively working to speed up the agency's review of her friend's proposal, raising concerns about the objectivity of the FDA's decision-making process.

The details

Urato, a maternal-fetal medicine specialist and critic of antidepressant safety, is pressing the FDA to add a boxed warning to SSRIs, the drugs most commonly prescribed for depression. Hoeg, who regularly consults with Urato, is working to bring him on as a full-time FDA employee. Within the agency, Hoeg's close relationship with Urato is viewed as a clear conflict of interest. However, Hoeg is actively working to speed up the agency's review of her friend's proposal, according to people familiar with the situation.

  • Last fall, Hoeg gave a talk on the SSRI petition to top FDA drug officials, presenting the work as her own.
  • In January, Urato was named to the Centers for Disease Control and Prevention's panel on vaccine recommendations.

The players

Dr. Tracy Beth Hoeg

The Food and Drug Administration's top drug regulator who is working to hire Dr. Adam Urato, a researcher and friend who wants the agency to add new warnings to antidepressants about unproven pregnancy risks.

Dr. Adam Urato

A maternal-fetal medicine specialist and critic of antidepressant safety who is pressing the FDA to add a boxed warning to SSRIs, the drugs most commonly prescribed for depression.

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What they’re saying

“A black box warning is a big red flag with both practitioners and patients. 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.”

— Dr. Jennifer Payne, University of Virginia reproductive psychiatrist

“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.”

— Dr. Adam Urato (Email)

What’s next

The judge in the case will decide on Tuesday whether or not to allow Walker Reed Quinn out on bail.

The takeaway

This case highlights growing concerns in the community about repeat offenders released on bail, raising questions about bail reform, public safety on SF streets, and if any special laws to govern autonomous vehicles in residential and commercial areas.