A bipartisan bill introduced to Congress by Georgia Republican Phil Gingrey the Generating Antibiotics Incentives Now (GAIN) Act attempts to spur interest among pharmaceutical companies to develop new and effective antibiotics, traditionally an unprofitable sector of the drug market. The new bill hopes to change all that by creating certain incentives. For instance, it would require the FDA to grant antibiotics priority review and even make them eligible for the agency s Fast Track approval program. In addition, new antibiotics would be granted five additional years of market exclusivity.
The hope is that, by providing various forms of market protection, drug makers will work to create antibiotics that can prevent, treat, detect, or identify resistant pathogens, such as methicillin-resistant Staphylococcus aureus (MRSA).
ACSH's Dr. Gilbert Ross believes the new proposals are very much in line with what ACSH has been advocating for years. Drug companies need a profit incentive in order to invest five to ten years of research and at least a half billion dollars into developing a new antibiotic, he says. Hopefully, this act will pass and will encourage further research and development of these drugs, which are desperately needed to combat the antibiotic-resistant and lethal organisms that are wreaking havoc in our hospitals today. These include not only MRSA but also VRE vancomycin-resistant enterococci and Clostridium dificile, known as C-dif.