BioCentury
ARTICLE | Politics & Policy

FDA proposes new reimbursement model for antimicrobials

June 12, 2018 2:34 PM UTC

FDA Commissioner Scott Gottlieb said Tuesday that FDA, CMS and other agencies are discussing changing the model for how new antimicrobials are reimbursed in order to counter the obstacles inherent in commercializing these drugs.

Gottlieb said the agency is considering a licensing model for reimbursement of antimicrobial products against multidrug resistant infections under which the acute care institutions most likely to prescribe them would pay a fixed licensing fee to access a certain number of annual doses of a drug. He said the model might offer an effective “pull incentive” to develop new drugs by providing a predictable return on investment and revenue stream...