Senators propose new antibiotics pathway

U.S. Sens. Michael Bennet (D-Colo.) and Orrin Hatch (R-Utah) introduced the Promise for Antibiotics and Therapeutics for Health ( PATH) Act to create a new approval pathway for antibiotics.

The bill, which will need to be reintroduced after the next Congress convenes in January, would allow FDA to accelerate the approval of antibacterial candidates to treat identifiable, limited patient populations with "serious or life-threatening" conditions where there is an unmet need. The legislation also would stipulate special labeling for drugs approved under the pathway and require postapproval monitoring. ...