The FDA's top drug regulator, Dr. Tracy Beth Hoeg, is facing scrutiny for working to hire a friend who wants new warnings on antidepressants. Dr. Adam Urato, a maternal-fetal medicine specialist, is pushing the agency to add a boxed warning to SSRIs about unproven pregnancy risks. Urato claims the medications can cause pregnancy complications, including miscarriages and fetal brain abnormalities.

Within the agency, Hoeg's close relationship with Urato is viewed as a clear conflict of interest that would typically require recusal. However, she is actively working to speed up the review of his petition, according to sources familiar with the situation. The proposed labeling change has become a top priority for Hoeg, who regularly consults with Urato and is working to bring him on as a full-time FDA employee.

Outside experts say the petition relies on flimsy data, including animal studies and small trials in people. They fear a new FDA warning could cause pregnant women to stop medication unnecessarily, leading to serious health risks from untreated depression. More than 15% of U.S. women take medication for depression, and professional guidelines state that antidepressants are generally safe during pregnancy and should be discontinued only after careful consultation with a doctor.