Although the FDA can't dictate prices or reject therapies over pricing concerns (they can only focus on safety and efficacy), the agency can encourage more competition through moves like this (as well as speedier approval pathways) which could spur drug makers to produce products that ultimately lower costs for patients — a goal cited by FDA Commissioner Scott Gottlieb in announcing the list. (fortune.com)
«FDA Issues Draft Guidelines for «Follow - on» Biologic Drug Approval Pathway,» Pharmaceutical Compliance Monitor, April 9, 2012 (mbhb.com)
The bill also lays out extensive new responsibilities for FDA, a new priority review process for antibiotics aimed at limited patient populations, a speedy «breakthrough» approval pathway for medical devices, and more than a dozen new guidance documents to advise drug developers. (sciencemag.org)