Late last night, the House of Representatives overwhelmingly supported the Food and Drug Administration Reform Act. Included in this bill is the Generating Antibiotic Incentives Now (GAIN) Act, a bipartisan bill introduced by Representatives Gene Green (D-TX) and Phil Gingrey (R-GA), and supported by several other Members from both sides of the aisle.
The GAIN Act is a critical step toward addressing the looming public health crisis of drug resistant bacterial infections. This bill gives the FDA the tools necessary to incentivize the development of next generation antibiotics that will keep us safe and healthy in the event of a virulent "superbug."
"As a physician for more than 30 years, I understand first-hand the urgent need for innovative, life-saving medical treatments," said Rep. Gingrey. "Unfortunately, the number of new drugs approved by the FDA has diminished significantly over the past two decades. If we are to prevent a future public health crisis, we must streamline the FDA regulatory process and ensure the further development of new antibiotics to treat dangerous "superbugs.' This legislation will encourage investment in new drug development and I look forward to it being signed into law."
"The incentives in this bill are critical to getting drugs to market that treat serious and life threatening infections that are currently unavailable," said Rep. Green, "There are already instances of death and serious complications in our country due to drug resistant pathogens. We cannot allow a reversion to the way things were before penicillin, when scraped knees and minor injuries were life threatening and difficult to treat. Without our bill, the drug companies will simply not develop these drugs and we will continue to be exposed to the risk of a large scale public health crisis, which experts believe is likely within the next ten years."
The GAIN Act provisions of the bill represent a careful bipartisan balance that appropriately protects patient safety and responsibly offers incentives to innovative drug companies seeking cures to the world's most deadly bacterial pathogens such as extensively drug resistant tuberculosis, MRSA, and others that we are currently ill-equipped to treat. The GAIN Act is supported by the public health community and the pharmaceutical industry.