The Generating Antibiotics Incentive Now (GAIN) Act was signed into law in 2011 by President Obama. It is designed to stimulate pharmaceutical companies to adopt and develop innovative antibiotics to counter the threat of resistance - download the PDF - click here
Seen by many as the first in a series of new laws and packages to be implemented in the US and EU the Act provides the building blocks by doing two things:
- Help lessen regulatory hurdles for New Drug Applications (NDAs) to treat serious infections, such as MRSA and Clostridium difficile, by giving an FDA priority review and fast track status;
- Extend market exclusivity of new products for 5 years, providing significant financial incentives to stimulate fresh investment into antibacterial R&D for large and small companies alike.