FDA to Increase Scrutiny of Antidepressants and RSV Immunizations; Antibiotic Supply Chain Faces Challenges

The U.S. Food and Drug Administration (FDA) is set to intensify its evaluation of antidepressants, particularly those used during pregnancy, and the respiratory syncytial virus (RSV) shots for infants. This announcement comes from Tracy Beth Høeg, the current head of the Center for Drug Evaluation and Research (CDER), in her first address to staff. Challenges in antibiotic production are emerging, potentially impacting global supply.

FDA Focus on Drug Safety

Høeg highlighted two key areas of focus: the safety of antidepressants taken by pregnant women and the effectiveness and safety of monoclonal antibodies designed to protect infants against RSV [STAT News]. She also expressed interest in broadening her focus to include vaccine policy within the drug center.

Høeg’s appointment follows the retirement of Richard Pazdur, the previous head of CDER, amid concerns regarding the politicization of the FDA’s scientific processes. She is the fifth individual to lead the drug center since the beginning of 2025 [STAT News]. Prior to her current role, Høeg was known for her efforts to limit access to Covid-19 shots and for taking over vaccine surveillance efforts [STAT News].

Antibiotic Production Concerns

Roche, a major pharmaceutical company, is seeking a buyer for one of its key antibiotics, Rocephin, and plans to cease manufacturing operations by 2030 [Euractiv]. This decision is attributed to rising manufacturing costs, declining prices, and increased competition from generic alternatives.

Rocephin is a crucial antibiotic used to treat severe bacterial infections, including meningitis and pneumonia, and is listed as an essential medicine by both the World Health Organization and the European Union [Euractiv].

Roche’s move reflects broader challenges within the European antibiotic market, where high-volume production often leads to unprofitability. Last year, Danish manufacturer Xelia also halted production of several key antibiotic ingredients [Euractiv].

The European Union is actively working to reduce its reliance on Asian generic drug manufacturers and encourage the relocation of production, including antibiotic production, closer to home under the new Critical Medicines Act [Euractiv].