BioCentury
ARTICLE | Politics & Policy

Reps. to introduce bill for antibiotic pathway, breakpoints

December 12, 2013 3:11 AM UTC

On Thursday, Reps. Phil Gingrey (D-Ga.) and Gene Green (D-Texas) are expected to introduce legislation in the U.S. House of Representatives that is anticipated to include provisions to create a limited population approval pathway for antibiotics and to recommend HHS update breakpoints for antibiotics based on pharmacokinetic and pharmacodynamic data. The sponsors declined to disclose details of the bill prior to its introduction.

The Infectious Diseases Society of America first proposed a limited population antibacterial drug (LPAD) approval pathway, which would allow for approval for antibiotics targeting serious or life-threatening infections based on clinical trials with smaller numbers of patients than trials for more widely used antibiotics (see BioCentury Extra, July 13). ...