The Food and Drug Administration's top drug regulator, Dr. Tracy Beth Hoeg, is working to hire a researcher and friend who is seeking new warnings on antidepressants about pregnancy risks, according to sources familiar with the matter.

Dr. Adam Urato, a maternal-fetal medicine specialist, has petitioned the FDA to add a boxed warning to SSRIs, the most commonly prescribed depression medications. His petition claims the drugs can cause pregnancy complications including miscarriages and fetal brain abnormalities that may lead to autism and other disorders in children. SSRIs include widely used medications such as Prozac, Paxil, and Zoloft.

Sources within the FDA say Hoeg's close relationship with Urato represents a clear conflict of interest that would typically require her to recuse herself from reviewing the petition. However, Hoeg is actively working to expedite the agency's review of Urato's proposal and has been working to bring him on as a full-time FDA employee.

Outside medical experts have criticized the petition, saying it relies on weak evidence including animal studies and small human trials. They warn that new FDA warnings could cause pregnant women to unnecessarily stop their medication, potentially leading to serious health risks from untreated depression. More than 15% of U.S. women take medication for depression, according to federal data.

The controversy comes as Hoeg, a sports medicine physician who gained attention during the COVID-19 pandemic as a critic of masking and vaccine mandates, leads the FDA's drug center during a period of significant upheaval. She was appointed in December and is the sixth person to lead the 5,000-person center in the past year. Professional medical guidelines currently state that antidepressants are generally safe during pregnancy and should only be discontinued after careful consultation with a doctor.