The Food and Drug Administration’s top drug regulator, Dr. Tracy Beth Hoeg, is working to hire Dr. Adam Urato, a maternal-fetal medicine specialist who is pressing the FDA to add a boxed warning to SSRIs regarding unproven pregnancy risks. Urato’s petition seeks a new warning about antidepressants’ potential to cause pregnancy complications, including miscarriages and fetal brain abnormalities that may lead to autism and other disorders. According to people familiar with the situation, Hoeg is actively working to speed up the agency’s review of her friend’s proposal, despite what experts view as a clear conflict of interest under normal FDA standards.
Outside experts say Urato’s petition relies on flawed data, including animal studies and small trials. They warn that a new boxed warning could cause pregnant women to stop medication unnecessarily, leading to serious health risks from untreated depression. More than 15% of U.S. women, or about 26 million people, take medication for depression according to federal figures. Professional guidelines state that antidepressants are generally safe during pregnancy and should be discontinued only after careful consultation with a doctor. Dr. Jennifer Payne, a University of Virginia reproductive psychiatrist, stated that a black box warning could be misleading because it would not address “the risks of maternal mental illness during pregnancy.”
Background and FDA Process
Hoeg, a sports medicine physician with no previous government or management experience, became head of the FDA’s drug center in December. During the COVID-19 pandemic, she attracted attention as a critic of masking, vaccine mandates, and other public health measures. The FDA is legally required to respond in writing to citizen petitions and explain its reasons for granting or denying requests. FDA officials typically avoid making public comments about matters under review because it could suggest the agency is basing decisions on individual opinions rather than science. Hoeg has told FDA staffers that their proposed nine-month review timeline for the SSRI petition needed to be shortened, according to people familiar with the situation.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.macombdaily.com/2026/03/04/fda-tracy-beth-hoeg-antidepressants/