The Infectious Diseases Society of America (IDSA) has proposed a mechanism to streamline the drug approval pathway to encourage development of new antibiotics. The move is part of an overall strategy for addressing the emerging public health crisis of antibiotic resistance.
The IDSA submitted its proposal to the House Energy and Commerce Committee's Subcommittee on Health during a March 8 hearing on reauthorizing the Food and Drug Administration Prescription Drug User Fee Act. The proposed new approval pathway, called the Special Population Limited Medical Use mechanism, would enable pharmaceutical companies to study designated drugs—intended for targeted use within a special population of patients who lack other treatment options—in far fewer patients than currently required, more rapidly, and at significantly less cost.
Mitka M. Antibiotic Pipeline. JAMA. 2012;307(14):1476. doi:10.1001/jama.2012.414