ARTICLE | Politics & Policy
HELP to discuss limited population antibiotic pathway
March 31, 2016 1:01 AM UTC
At an April 6 hearing, the U.S. Senate Health, Education, Labor and Pensions Committee plans to mark up a bill that would create an approval pathway for antibiotics that address an unmet need in a limited population with a serious or life-threatening disease, condition or infection.
The Promise for Antibiotics and Therapeutics for Health Act ( S. 185) would permit such approvals based on safety and efficacy evidence including "traditional endpoints, alternate endpoints, or a combination of traditional and alternate endpoints, and, as appropriate, small clinical data sets." The Infectious Diseases Society of America first proposed a limited population antibacterial drug (LPAD) approval pathway. ...