Industry News and Headlines

FDA Drug Official Moves To Hire A Friend Who Touts Unproven Claims About Antidepressants

The FDA’s acting CDER director, Dr. Tracy Beth Hoeg, is reportedly moving to hire Dr. Adam Urato, a maternal‑fetal specialist who is petitioning the agency to add boxed warnings about alleged pregnancy risks of antidepressants. Urato’s claims rely on limited animal data and small human studies that many experts deem insufficient. The move has raised conflict‑of‑interest concerns among FDA staff, who note that robust research supports the safety of SSRIs during pregnancy and highlights the dangers of untreated maternal depression. The outcome could reshape labeling and prescribing practices for millions of women.