New pathway proposed for antibiotic approval in USA

The US Congress will consider a new drug approval pathway to encourage development of critically needed, lifesaving antibiotics as part of a strategy to address the public health crisis of antibiotic resistance.

The Infectious Diseases Society of America (IDSA) proposed the new pathway, the Special Population Limited Medical Use (SPLMU) mechanism, to provide an important new approval option for companies interested in developing drugs to treat patients with serious infections where few or no treatment options exist.

The IDSA submitted the proposal to the House Energy and Commerce Committee Subcommittee on Health during a hearing on the US Food and Drug Administration Prescription Drug User Fee Act (PDUFA) reauthorization legislation. During the hearing, lawmakers will consider whether to incorporate within PDUFA pending legislation known as the Generating Antibiotic Incentives Now (GAIN) Act, which proposes incentives to address the dry antibiotic R&D pipeline. PDUFA is considered one of the few “must-pass” bills this year in Congress.