Incentives for New Antibacterial Drugs
Governments and healthcare regulators are now committed to the development of new products to combat the threat of microbial resistance. To this end a number of incentives have been launched to encourage the development of such products. In the US the Generating Antibiotic Incentives Now (GAIN) Act and Qualified Infectious Disease Product (QIPD) designation were introduced by the FDA in August 2014.
QIDP status is awarded to products which target the highest risk pathogens, both MRSA and SA are included within the terms of the GAIN act.
Destiny Pharma’s XF-73 drug (exeporfinium chloride) was awarded QIDP designated by the FDA in October 2015 for a new US indication of, The Prevention of Post-Surgical Staphylococcal Infections.
QIDP designation for a drug provides 5 years additional US market exclusivity and fast-track status which includes priority review.
The 21st Century Cures Act is another US bill who’s goal is to accelerate the discovery, development and delivery of life-saving and life-improving therapies and to transform the quest for faster cures. This Act is currently in the final stages of US government approval and may provide additional incentives for new antibacterial drug development.
Further incentives from governments, multi-national organisations and regulators are being pursued. These include the Independent Review on Antimicrobial Resistance (IRAR) commissioned by the UK government. The IRAR is being undertaken with international stakeholders and will propose economic incentives to promote new antimicrobial drug development. This is scheduled to complete in 2016 and has become a global initiative with the intention of providing its findings and recommendations to the G7 and the WHO and UN General Assemblies.
The US President, Barack Obama has produced a comprehensive plan (The National Action Plan for Combating Antibiotic-Resistant Bacteria) that identifies critical actions to be taken by key Federal departments and agencies to combat the rise of antibiotic-resistant bacteria.
The World Health Organisation (WHO)’s 2014 report on global surveillance of antimicrobial resistance revealed that antibiotic resistance is no longer a prediction for the future; it is happening right now, across the world, and is putting at risk the ability to treat common infections in the community and hospitals. “Without urgent, coordinated action, the world is heading towards a post-antibiotic era, in which common infections and minor injuries, which have been treatable for decades, can once again kill“.