Gottlieb: FDA, CMS Eye New Non-Volume-Based Pay Model For Antibiotics

FDA Commissioner Scott Gottlieb said he is discussing with CMS the possibility of a new license-based reimbursement model for antibiotics that would spare drug makers some of the disincentives that usually come with antibiotic development, such as the low volume of sales that occur when providers try to use antibiotics sparingly. Gottlieb also unveiled draft guidance Tuesday (June 12) outlining a streamlined approach for development and approval of antibacterial drugs that treat limited populations of patients with unmet medical needs...