[WASHINGTON, DC] – Following the discovery of a bacteria resistant to colistin, an antibiotic of last resort, U.S. Senator Richard Blumenthal (D-CT, along with Senators Michael Bennet (D-CO) and Orrin Hatch (R-UT), will introduce the bipartisan Promise for Antibiotics and Therapeutics for Health (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.
“This critical legislation will help develop new drugs to combat the deadly threat of superbugs. These antibiotic resistant infections are a menace that mandate urgent action-- including a streamlined path to approval of new antibiotics to fight them. The alarming arrival of this superbug signals the potential emergence of a truly dangerous bacteria resistant to all antibiotics, and a looming public health crisis that we cannot ignore,” said Blumenthal.
Earlier this week, Blumenthal joined Dr. Jack Ross, the Director of Infectious Disease at Hartford Hospital, to call for action to fight the spread of antibiotic-resistant bacteria and for passage of the PATH Act. Blumenthal has also previously led bipartisan efforts to spur development of new drugs to treat increasing cases of bacterial infections resistant to conventional antibiotics.
“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, affecting more than a third of returning Iraq and Afghanistan veterans, 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 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 bill includes several provisions to guide appropriate use of antibiotics approved under this pathway, such as labeling and promotional material requirements.