FDA Official Seeks to Have Friend's Research Considered for Warning Label on Antidepressants

FDA Drug Regulator Faces Conflict of Interest with Antidepressant Warning Proposal

The Food and Drug Administration (FDA) is facing a conflict of interest in its review of a citizen petition to add a boxed warning to Selective Serotonin Reuptake Inhibitors (SSRIs), the most commonly prescribed antidepressants. Dr. Tracy Beth Hoeg, the FDA's top drug regulator, is working to hire Dr. Adam Urato, a maternal-fetal medicine specialist and critic of antidepressant safety, as a senior adviser at the agency.

Dr. Urato is pressing the FDA to add a boxed warning to SSRIs, citing unproven pregnancy risks, including miscarriages and fetal brain abnormalities that may lead to autism and other disorders in children. However, outside experts have raised concerns that the petition relies on flimsy data and could lead to serious health risks from untreated depression.

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, and Zoloft. Over 15% of U.S. women, or about 26 million people, take medication for depression, according to the latest federal figures.

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Dr. Hoeg gave a talk on the SSRI petition to top FDA drug officials, presenting the work as her own, although the slides were created by Dr. Urato. The incident was first reported by Stat News. Dr. Urato has been named to the Centers for Disease Control and Prevention's panel on vaccine recommendations, which has been reshaped by Health Secretary Robert F. Kennedy Jr. to include anti-vaccine voices.

This is the latest in a series of controversial topics taken up by Dr. Hoeg, a sports medicine physician with no previous government or management experience. Before the pandemic, Dr. Hoeg had published only a handful of medical papers, including one on health issues affecting ultramarathon runners.