Encourages Innovation in Antibiotic Research & Development to Combat Superbug Threat to Soldiers, Public Health
Washington, D.C. - Following the discovery of a bacteria resistant to colistin, an antibiotic of last resort, U.S. Senators Michael Bennet (D-CO) and Orrin Hatch (R-UT) will introduce their bipartisan PATH Act as an amendment to the National Defense Authorization Act for Fiscal Year 2017. The measure would create a new drug approval pathway to bolster innovation and encourage development of potentially life-saving antibiotic drugs for patients, including servicemembers serving overseas who are particularly at risk of exposure to antibiotic-resistant bacteria.
"Superbugs are a growing threat to our public health and national security," Bennet said. "The colistin-resistant bacteria found in a patient in Pennsylvania underscores how vulnerable we are to a growing number of superbugs. Yet, research has lagged to the point where a truly novel antibiotic hasn't been discovered in more than 30 years. This bipartisan amendment would encourage researchers to find new antibiotics to treat otherwise unstoppable infections before it's too late."
"Doctors and patients across the country increasingly face life-threatening bacteria that have grown resistant to even our most powerful antibiotics," said Senator Hatch. "More than 60 percent of infectious disease doctors have treated patients with infections that did not respond to any antibiotics. The discovery that the mcr-1 gene capable of spreading antibiotic resistance among bacterial species is now found in the U.S. makes the need for action imperative. This amendment would spur the urgently-needed innovation of new antibiotics to treat the most serious of superbugs."
"Superbugs"-or bacteria that are substantially resistant or unresponsive to any existing and available antibiotic-are an increasingly urgent public health threat, both at home and abroad. While antibiotic-resistant bacteria kills thousands of Americans each year, less than ten new antibiotics have made it to market since 2000. Antibiotic-resistant bacteria is also a significant concern to our troops. More than one-third of injured Iraq and Afghanistan veterans developed a potentially life-threatening bacterial or fungal infection, according to the Department of Defense.
In an effort to address some of the significant regulatory obstacles hindering antibiotic development and patient access to life-saving treatments, the Promise for Antibiotics and Therapeutics for Health (PATH) Act would permit the Food and Drug Administration (FDA) to approve an antibacterial drug for a limited patient population upon determining that the drug treats a serious or life-threatening condition and addresses an unmet need. In addition, the amendment includes several provisions to guide appropriate use of antibiotics approved under this pathway, such as labeling and promotional material requirements. It also calls for the implementation of antibiotic stewardship programs and more robust surveillance of bacterial resistance through the CDC's National Healthcare Safety Network and other national tracking systems, which will be critical to monitoring this evolving threat.
Bennet and Hatch introduced the Promise for Antibiotics and Therapeutics for Health (PATH) Act as a standalone bill early last year. The Senate Health, Education, Labor, and Pensions (HELP) Committee approved the bill in April.