The Senate Health, Education, Labor, and Pensions (HELP) Committee held a mark-upWednesdayto consider the PATH Act, sponsored by Senators Orrin G. Hatch (R-UT) and Michael Bennet (D-CO). This legislation would create a new drug approval pathway to streamline access, bolster innovation, and encourage development of potentially life-saving antibiotic drugs for patients.
“The world is facing a critical threat of life-threatening bacteria that have grown resistant to even our most powerful antibiotics,”Hatch said.“Sixty-three percent of infectious disease doctors have treated patients with infections that did not respond to any antibiotics. Two million Americans acquire serious infections caused by antibiotic-resistant bacteria each year, and 23,000 people die annually from these infections. A dearth of antibiotic drugs in development compounds this crisis. Consider that almost three decades have passed without the discovery of new types of antibiotics. We need to develop new antibiotics to treat the most serious of superbugs, and the PATH Act would significantly spur such action.”
“Over the last few years we’ve experienced a lag in the development of new antibiotic treatments,” Bennet said. “We need new drugs to fight antibiotic-resistant bacteria that pose serious and unique challenges to health care professionals, veterans, and vulnerable populations. This bill will encourage research and development of new drugs that could save the lives of thousands of Americans each year.”
“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 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 bill includes several provisions to guide appropriate use of antibiotics approved under this pathway, such as labeling and promotional material requirements.