FDA Scrutiny of Antidepressants & RSV Shots, Antibiotic Production Shifts – Week in Pharma News

Tracy Beth Høeg, the newly appointed head of the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER), outlined her priorities in a Thursday address to staff, signaling increased scrutiny of antidepressants used during pregnancy and respiratory syncytial virus (RSV) protective shots for infants, STAT reported.

Høeg, who assumed her position in December following the retirement of Richard Pazdur, indicated she would revisit issues she previously focused on, including the safety profile of antidepressants taken by pregnant women and the monoclonal antibodies designed to safeguard infants against RSV. She too expressed an intention to integrate her existing interest in vaccine policy into her role at the CDER.

Prior to her appointment, Høeg had taken steps to limit access to Covid-19 shots and assumed control of vaccine surveillance efforts, shifting responsibilities from career staff. Her arrival at the CDER marks the fifth leadership change at the drug center since the beginning of 2025, a period marked by concerns regarding the politicization of FDA scientific processes, as reported by STAT.

In separate news, pharmaceutical company Roche announced its plans to seek a buyer for one of its key antibiotics, Rocephin, and to cease manufacturing operations by 2030, according to Euractiv. The decision, attributed to rising production costs, declining prices, and increased competition from generic alternatives, impacts a drug listed as essential by both the World Health Organization and the European Union.

Rocephin is utilized in the treatment of severe bacterial infections, including meningitis, and pneumonia. Roche’s move occurs as the European Union intensifies efforts to reduce its reliance on Asian generic drug manufacturers and encourage production within the bloc, including Switzerland, under the new Critical Medicines Act. The antibiotic market has proven unprofitable for European companies due to the high volume of production required. Last year, Danish manufacturer Xelia halted production of several key antibiotic ingredients, signaling a broader trend within the industry.