Stakeholders press Congress for new antibiotic regulatory pathway
A group of stakeholders sent a letter to several representatives and senators who have expressed support for the limited population antibacterial drug (LPAD) approval pathway urging them to enact legislation to create the pathway for antibiotics targeting serious or life-threatening infections. The Infectious Diseases Society of America proposed the approval pathway, which would allow for approval based on clinical trials with smaller numbers of patients than trials for more widely used antibiotics (see BioCentury, Jan. 28).
The letter -- which was signed by 20 organizations, including Cempra Inc. (NASDAQ:CEMP), Tetraphase Pharmaceuticals Inc. (NASDAQ:TTPH) and Rempex Pharmaceuticals Inc. (San Diego, Calif.) -- suggests requiring labels to distinguish products approved under the pathway from other antibiotics, as well as a mechanism to collect information to evaluate the utility of the pathway. The letter also notes that narrow indications could "allow for value-based or premium pricing for high-need antibiotics," which may encourage R&D investment. ...