Top FDA official seeks to hire friend pushing new antidepressants warning

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The Food and Drug Administration’s top drug regulator, Dr. Tracy Beth Hoeg, is working to hire a researcher and friend, Dr. Adam Urato, who is seeking a new boxed warning on antidepressants about pregnancy risks, The Associated Press reported. The request centers on SSRIs, a class that includes Prozac, Paxil and Zoloft, and the FDA is legally required to respond to the citizen petition in writing with its reasons.

Urato, described by the AP as a maternal-fetal medicine specialist and critic of antidepressant safety, is pressing the FDA to add new warnings to SSRIs. The AP report says Urato’s petition argues the drugs can cause pregnancy complications, including miscarriages and fetal brain abnormalities that he links to autism and other disorders in children. The petition has become a “top priority” for Hoeg, according to people familiar with the matter who spoke with the AP on the condition of anonymity to discuss confidential FDA work.

The AP report also said Hoeg has a close working relationship with Urato and has been consulting with him on the SSRI petition. People familiar with the situation told the AP that Hoeg is actively working to speed up the agency’s review of Urato’s proposal even though, under “normal FDA standards,” the relationship would likely require recusal from any work on the petition.

Within the agency, the AP reported that Hoeg’s relationship with Urato is viewed as a “clear conflict of interest” that would normally trigger recusal. Outside experts, meanwhile, told the AP they believe the petition leans on “flimsy data,” including animal studies and small trials in people, and they said a new warning could lead pregnant women to stop taking antidepressants unnecessarily.

Reproductive psychiatrist Dr. Jennifer Payne of the University of Virginia said in an interview provided to the AP that “A black box warning is a big red flag with both practitioners and patients.” She added that “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 AP report also said Hoeg’s approach to the petition is part of a broader pattern that has drawn attention during her time as FDA’s top drug official. The report described Hoeg as a sports medicine physician who had not held previous government or management experience before leading the agency’s drug center, and it said she drew attention during the COVID-19 pandemic for criticism of masking and vaccine mandates.

According to the AP, Hoeg co-wrote papers with medical contrarians who later joined the Trump administration, including FDA Commissioner Marty Makary and FDA vaccine chief Dr. Vinay Prasad—figures described by the AP as top surrogates for Robert F. Kennedy Jr. The AP also said Hoeg helped drive a Republican administration decision to drop some vaccine recommendations for children, which she has long proposed as a way to align the United States more with Denmark.

The AP report further said Hoeg hosted an FDA panel last July on SSRIs that included Urato and eight other critics of the drugs, and that Hoeg echoed points from Urato in a podcast afterward. In the same AP report, Hoeg is quoted as telling the hosts of the “Mom Wars” podcast, “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.”

Federal reviews of citizen petitions follow legal and scientific steps, the AP report said, and the agency is required to respond in writing to grant or deny each petition. The AP also reported that FDA staff typically avoid public comment on matters under review, but said Hoeg took a hands-on approach by telling staff that the agency’s proposed nine-month review timeline needed to be shortened, according to people familiar with the situation.

Researchers who reviewed the AP’s description of Urato’s arguments said they worry that studies used to connect SSRIs to disorders such as autism do not adequately account for other health factors that can also affect pregnancy outcomes and child development. Dr. Amritha Bhat, a University of Washington perinatal psychiatrist, said in comments to the AP that “So how do we say that these outcomes are a result of the SSRI when all of these other factors are at play?” Bhat and other researchers told the AP they support more research on SSRIs’ effects during pregnancy while acknowledging possible downsides.

On Wednesday, Urato responded to the AP report by email, saying that Hoeg is “an excellent scientist,” and that they have known each other for several years. Urato told the AP, “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,” according to the report.

A spokesman for the Department of Health and Human Services, which oversees the FDA, told the AP that the agency would respond directly to Urato about his petition. The AP report said the antidepressant review is likely to remain part of a wider controversy around Hoeg’s leadership and the degree to which her relationships and public comments intersect with ongoing FDA decision-making.

Finally, the AP report underscored that antidepressant safety during pregnancy has been scrutinized for decades and that antidepressant labels have previously included warnings, including a black box warning about suicidal behavior in children. For pregnant women, the AP said the current label lists documented safety issues, including risks of excess bleeding after giving birth, and doctors describe weighing those risks against harms that can follow when depression worsens or relapse occurs.