16 Dec 2016 – 21st Century Cures Act signed into law by President Obama

Destiny Pharma welcomes the enactment of the US 21st Century Cures Act. The provisions of the act underline the commitment of all those involved in the furtherance of policies to assist the development of novel medicines and to the removal of obstacles. Destiny is particularly pleased to see the retention of many of the specific policies to gather data on antimicrobial resistance patterns, to support antimicrobial stewardship and to provide practical drug approval pathways for tackling the most important microbial pathogens.

The Limited Population Pathway provides a route to the approval of antimicrobial products geared towards the most serious life threatening infections in difficult to study patient populations.  Allowing the use of very limited patient numbers in exchange for restrictive labelling and controlled marketing of the products. This measure seeks to address the issue of unavailability of highly restricted and difficult to find patients and seeks to drive the antimicrobial drug approval process for the most serious infections.