FDA's new drug chief to prioritize antidepressants in pregnancy, RSV shots

FDA's new drug chief targets antidepressants, RSV shots

Tracy Beth Høeg, the new head of the FDA's Center for Drug Evaluation and Research (CDER), has signaled she will prioritize the safety of antidepressants in pregnancy and infant RSV immunizations. She outlined these goals in her first address to agency staff on Thursday.

Høeg stated that her focus stems from her recent work and concerns over safety monitoring. She emphasized a need for more rigorous evaluation of these specific drug categories.

Scrutiny on antidepressants during pregnancy

Høeg pointed to a significant gap in safety surveillance for antidepressants used by pregnant women. "I’ve been interested to learn we really haven’t been doing sort of thorough safety monitoring of these products during pregnancy," she told staff.

She expressed optimism that there is internal agreement on improving this monitoring. Her comments suggest a potential shift in how the FDA evaluates the risks and benefits of SSRIs and similar drugs for this vulnerable population.

Review of infant RSV protections

The second major priority is the safety of monoclonal antibodies used to protect infants from RSV. This includes products like Beyfortus (nirsevimab), which was approved in 2023.

Høeg's scrutiny comes amid high demand and some supply challenges for these shots. Her focus will likely involve post-market safety data and the risk-benefit profile for the youngest patients.

Høeg's background and immediate impact

Høeg, an epidemiologist and physician, was appointed to lead CDER earlier this month. Her early comments indicate she will push the agency on issues where she has previously conducted research and raised concerns.

Key areas she highlighted for immediate attention include:

• Enhanced pregnancy safety reviews for antidepressants.
• Ongoing safety evaluation of infant RSV immunizations.
• Strengthening the FDA's overall pharmacovigilance systems.

Her direct reference to existing work with CDER staff suggests these reviews are already in motion. This marks a clear and specific agenda for one of the FDA's most critical divisions.