Generating Antibiotics Incentives Now (GAIN) Act
On July 9th, 2012, President Barack Obama signed into law the Food and Drug Administration Safety and Innovation Act and with it the Generating Antibiotics Incentives Now (GAIN) Act, which includes provisions to incentivize research and development of antibiotics. The Hartford Courant – citing Dr. Jeffrey Townsend, a professor in the Department of Ecology and Evolutionary Biology at Yale, described the GAIN Act as “brilliant.” In June of 2012, described GAIN as “…a Holy Cow provision.” Because of the dearth of antibiotics coming to market to treat a growing list of antibiotic-resistant infections, the antibiotic pipeline is running dry and, in turn, placing the public health at risk. Through the GAIN Act, Congress has addressed the issue of antibiotic resistance at a critical juncture: according to CDC data, more than 1.7 million people acquire bacterial infections in U.S. hospitals each year — and 99,000 people die as a result of these bacterial infections, of which up to 70 percent are resistant to at least one drug.
Title VIII - Generating Antibiotic Incentives Now (GAIN)
Incentives are provided under Title VIII of the new Generating Antibiotic Incentives Now (GAIN) statute, which received strong bipartisan support in Congress and was signed into law by President Obama in July 2012.Download
Antimicrobial Resistance: An Epic Story of Burden and Progress.
One year in, the GAIN Act spurs innovation in antibiotic development. See it here
Transatlantic Taskforce on Antimicrobial Resistance
The full report can be found here
List of GAIN supporters
- Regulatory Focus - FDA Looks to Spur Antibiotic Drug Development by Adding 18 Pathogens to Incentives List
- The Vancouver Sun - Incentives needed for antibiotic R&D
- The Washington Times - Federal funds sought to fight gonorrhea ‘superbug’
- FDA - Task Force News Release (9/24/12)
- IDSA - Drug Companies, Health Groups Back IDSA Proposal
- The Hill’s feature on Innovation Key to fighting 'super bugs'
- GAIN Act Introduced on Senate Floor - see the floor speech
- Blumenthal, Corker Introduce Bill to Combat Antibiotic Resistant “Superbugs”
- FDA - Task Force Goals
- IDSA - Limited Population Antibacterial Drug (LPAD) Approval Mechanism