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# Hoeg Recruits Petitioner Seeking New SSRI Warnings
- URL: https://www.fdaweb.com/hoeg-recruits-petitioner-seeking-new-ssri-warnings/
- Published: 2026-03-04T12:00:00.000Z
- Updated: 2026-09-14T13:34:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160761

FDA is reviewing a petition to add sweeping new Warnings to commonly prescribed antidepressants, a process now complicated by the involvement of the agency’s top drug official, who is attempting to hire the physician behind the request. Acting CDER director **Tracy Beth Hoeg** is reportedly working to recruit **Adam Urato**, a maternal-fetal medicine specialist who has formally petitioned the agency to require Boxed Warnings on selective serotonin reuptake inhibitors, or SSRIs. According to individuals familiar with the matter who spoke to the [Associated Press](https://www.usnews.com/news/business/articles/2026-03-04/top-fda-drug-official-is-trying-to-hire-a-friend-whos-seeking-a-bold-new-warning-on-antidepressants?ref=fdaweb.com), Hoeg has also pushed internally to accelerate the agency’s review of Urato’s petition.

Urato’s filing asks the FDA to add its most prominent safety warning to SSRIs, citing alleged links between the drugs and pregnancy complications, including miscarriage and fetal brain abnormalities that he suggests could contribute to autism and other developmental disorders. SSRIs include some of the most widely prescribed antidepressants in the U.S., such as Prozac, Paxil and Zoloft, along with their generic equivalents.

Within FDA, Hoeg’s relationship with Urato has raised concerns about a potential conflict of interest. Under standard agency practice, officials typically recuse themselves from matters involving close associates. But people familiar with the review say Hoeg has remained directly involved and has urged staff to shorten an initial nine-month review timeline.

Urato said in an email to the AP that he considers Hoeg “an excellent scientist” and described their relationship as collegial rather than a longstanding personal friendship. In January, Urato was appointed to a Centers for Disease Control and Prevention advisory panel on vaccine recommendations that was recently restructured under HHS secretary **Robert F. Kennedy Jr**.'s leadership.

Outside experts have sharply criticized the scientific foundation of the proposal, according to the AP. They say the petition relies heavily on animal research and small human studies, and fails to account for confounding factors common among patients with depression, such as smoking, diabetes and family histories of psychiatric illness.

“A black box warning is a big red flag with both practitioners and patients,” **Jennifer Payne**, a reproductive psychiatrist at the University of Virginia, told the AP. “What’s missing is a full accounting of the risks of untreated maternal mental illness — not just to the woman, but to the pregnancy and infant.”

More than 15% of U.S. women take medication for depression, according to federal data. Current professional guidelines generally consider antidepressants acceptable during pregnancy when clinically indicated, recommending individualized risk-benefit discussions rather than automatic discontinuation.

The episode marks the latest flashpoint in Hoeg’s tenure atop the FDA’s drug center. A sports medicine physician with limited prior government management experience, Hoeg rose to prominence during the Covid-19 pandemic as a critic of masking and vaccine mandates. She co-authored research with medical figures who later joined the Trump administration, including FDA commissioner **Marty Makary** and the agency’s top vaccine regulator, **Vinay Prasad**. All three have been allies of HHS secretary Kennedy.

Hoeg has previously expressed skepticism about antidepressant use. Last summer, she convened an FDA panel discussion on SSRIs that included Urato and other critics of the drugs. On a subsequent podcast appearance, she said women should be informed about potential risks so they have time to discontinue SSRIs before attempting pregnancy, if they choose.

FDA officials typically avoid public commentary on issues under active review to preserve the appearance of scientific neutrality. But staff members say Hoeg has taken a hands-on role in the antidepressant petition, instructing reviewers to move more quickly through the detailed scientific and legal analyses required for citizen petitions, according to the AP.

**Patti Zettler**, a former FDA attorney now at Ohio State University’s law school, said compressing the review process could expose the agency to litigation risk. “Beyond serving FDA’s public health mission, there’s always concern about legal vulnerability if the agency doesn’t take sufficient time to evaluate all relevant data and arguments,” Zettler told the AP.

The safety of antidepressants has been debated for decades, and existing FDA labels already include Boxed Warnings about suicidal behavior in children and adolescents, as well as language detailing certain pregnancy-related risks, such as postpartum hemorrhage. Physicians who treat depression during pregnancy emphasize that untreated illness can carry significant dangers, including self-harm, substance misuse and adverse birth outcomes.

“We need more research, absolutely,” said **Amritha Bhat**, a perinatal psychiatrist at the University of Washington. “But in the meantime, we can’t ask patients to simply endure severe depression without treatment.”