Top FDA drug official trying to hire friend who seeks bold new warning on antidepressants

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. His petition says the medications can cause pregnancy complications, including miscarriages and fetal brain abnormalities that may lead to autism and other disorders in children.

Hoeg regularly consults with Urato and is working to bring him on as a full-time FDA employee, according to people familiar with the situation who spoke on condition of anonymity.

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 work on the petition. But Hoeg worked to speed up the agency's review of her friend's proposal, the people said.

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.

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 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 found her slides 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 they have known each other for years. "I am friendly with her, as I am with many colleagues, but we do not have a longstanding personal friendship that would in any way prevent her from reviewing the citizen petition," he said.

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 Health Secretary Robert F. Kennedy Jr. reshaped to include anti-vaccine voices.

COVID-19 contrarian elevated into FDA's leadership

Hoeg is a sports medicine physician with no previous government or management experience.

During the COVID-19 pandemic, she attracted attention as a critic of masking, vaccine mandates and other public health measures. She co-wrote papers with medical contrarians who joined the Trump administration, including FDA Commissioner Marty Makary and FDA's vaccine chief, Dr. Vinay Prasad.

Before the pandemic, Hoeg published only a handful of medical papers, including one on health issues affecting ultramarathon runners.

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.

Like many critics of vaccines, including Kennedy, Hoeg also is skeptical of antidepressants, questioning their safety and benefits.

"I think women should be informed about the potential risks so that they have time to come off SSRIs if they want to when they're trying to get pregnant," Hoeg told the hosts of the Mom Wars podcast.

FDA officials typically avoid making public comments about matters under review because it could suggest the agency is basing its decision on individual opinions, rather than science.

Reviewing a citizen petition involves detailed analysis of scientific references, legal issues and a number of other steps to ensure that the agency's final decision can be defended in court.

Hoeg was tapped to the lead FDA's drug center in December, during a period of unprecedented upheaval, including layoffs, buyouts and leadership changes. She is the sixth person to lead the 5,000-person center in the past year.

Staffers did not hear from Hoeg directly until a town hall last month, where she voiced her concerns about the safety of SSRIs and injectable RSV shots for children, a class of drugs that FDA is reviewing at her request. RSV is a respiratory virus that sends thousands of children in the U.S. to hospitals each year.

The safety of antidepressants was scrutinized for decades, leading to updates to their FDA label, including the addition of a black box warning about the risk of suicidal behavior in children.

For pregnant women, the label lists a number of documented safety issues, including risks of excess bleeding after giving birth.

Doctors say they discuss those risks with their patients, balancing the possible safety issues against the potential harms of relapsing into depression: self-harm, substance abuse and other behaviors that negatively affect women and fetuses.

Researchers who reviewed Urato's SSRI petition say many of the studies claiming to show connections to disorders such as autism don't take into account other important health factors. For example, women with depression have higher rates of smoking, diabetes and family histories of mental illness that can all increase the likelihood of developmental disorders.

"So how do we say that these outcomes are a result of the SSRI when all of these other factors are at play?" said Dr. Amritha Bhat, a University of Washington perinatal psychiatrist.