Antibiotic Action has noted with interest the US Congressional approval of the GAIN Act, also known as Generating Antibiotic Incentives Now. The Act contains provisions that provide the pharmaceutical and biotech industry with incentives to develop antibiotics to treat life-threatening infections caused by drug resistant pathogens and is expected to be signed into law by President Obama before July 4, 2012.
The Act has been welcomed by pharmacuetical companies with Jeffrey Stein, CEO of Trius commenting “The GAIN Act provides companies like Trius with new regulatory options that can facilitate our efforts to develop effective new treatments for infections caused by drug resistant bacteria.” He continued ”The fact that PDUFA V received overwhelming bipartisan support in both houses in Congress, as evidenced by yesterday’s 92-4 vote of support by the Senate, should serve as ample testimony of the growing recognition for the urgent need for new antibiotic drugs.”
Specific provisions of the GAIN Act include an additional five years of market exclusivity for companies developing antibiotics targeting life-threatening infections caused by drug-resistant pathogens, such as methicillin-resistant Staphylococcus aureus (MRSA). In addition, new drug applications for such products could qualify for Priority and Fast Track review with the US Food and Drug Administration (FDA), potentially reducing the time to approval for qualifying new antibiotic products.
Antibiotic Action is working with colleagues in the US to promote the need for new antibiotic discovery and development and looks forward to seeing the differences the GAIN Act will bring, and will take benefits forward for discussion with UK goverment.