The Food and Drug Administration’s top drug regulator, Dr. Tracy Beth Hoeg, is working to hire a researcher and friend who wants the agency to add new warnings to antidepressants about unproven pregnancy risks, The Associated Press has learned.

Dr. Adam 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. Urato’s petition says the medications can cause pregnancy complications, including miscarriages and fetal brain abnormalities that might lead to autism and other disorders in children.

That 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, according to people familiar with the situation. They spoke to the AP on condition of anonymity to discuss confidential FDA matters.

Within the agency, Hoeg’s close relationship with Urato is viewed as a clear conflict of interest that, under normal FDA standards, would result in her recusing herself from any work on the petition. But Hoeg is actively working to speed up the agency’s review of her friend’s proposal, according to the people familiar with the situation.

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.

“A black box warning is a big red flag with both practitioners and patients,” said Dr. Jennifer Payne, a University of Virginia reproductive psychiatrist. “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.”

The FDA is legally required to respond in writing to each citizen petition and explain its reasons for granting or denying the request.

SSRIs include most of the bestselling depression medications, including Prozac, Paxil, Zoloft and their generic equivalents.

More than 15% of U.S. women, or about 26 million people, take medication for depression, according to the latest federal figures. Professional guidelines state that antidepressants are generally safe during pregnancy and should be discontinued only after careful consultation with a doctor.

Last fall, Hoeg gave a talk on the SSRI petition to top FDA drug officials, presenting the work as her own. Staffers who reviewed her slides found they were created by Urato, according to the people who spoke to the AP. The incident was first reported by Stat News.

Urato said in an email Wednesday that Hoeg is “an excellent scientist,” and that they have known each other for several years.

A spokesman for the Department of Health and Human Services, which oversees the FDA, said that the agency would respond directly to Urato about his petition.

In January, Urato was named to the Centers for Disease Control and Prevention’s panel on vaccine recommendations, which has been completely reshaped by Health Secretary Robert F. Kennedy Jr. to include a number of anti-vaccine voices.

The antidepressant review is the latest in a series of controversial topics taken up by Hoeg, a sports medicine physician with no previous government or management experience.

During the COVID-19 pandemic, Hoeg attracted attention as a critic of masking, vaccine mandates and other public health measures. She co-wrote papers with medical contrarians who would go on to join the Trump administration.

Before the pandemic, Hoeg had published only a handful of medical papers.

A Danish American citizen and marathon runner, Hoeg was instrumental in the Republican administration’s recent decision to drop a number of vaccine recommendations for children.