FDA Leader Prioritizes SSRI Pregnancy Warning Petition Amid Hiring Issue

The Food and Drug Administration's top drug regulator, Dr. Tracy Beth Hoeg, has made a citizen petition to add warnings about unproven pregnancy risks to antidepressants a priority, while working to hire its author, Dr. Adam Urato, a maternal-fetal medicine specialist she regularly consults, according to people familiar with the matter.

Urato's petition seeks a boxed warning on selective serotonin reuptake inhibitors, or SSRIs, the most commonly prescribed class of antidepressants, claiming they can lead to pregnancy complications such as miscarriages and fetal brain abnormalities potentially linked to autism and other developmental disorders in children. Hoeg, who leads the FDA's Center for Drug Evaluation and Research, has expedited the agency's review of the proposal, shortening a proposed nine-month timeline, the people said. They spoke on condition of anonymity to discuss internal FDA deliberations. Hoeg is also seeking to bring Urato on as a full-time employee.

Inside the agency, Hoeg's relationship with Urato is seen as a conflict of interest that would typically require her to recuse herself from handling the petition, the people said. Last fall, Hoeg presented slides on...