Senators introduce bill for streamlined pathway to approval for antibiotics
Friday, December 12, 2014
U.S. Senators Michael Bennet (D-CO) and Orrin Hatch (R-UT) have introduced a bill to create a new drug approval pathway to streamline access and encourage innovation and development of potentially lifesaving antibiotic drugs for patients, particularly Veterans who have encountered antibiotic-resistant bacteria while overseas.
In an effort to address some of the significant regulatory obstacles facing antibiotic development and hindering patient and veteran access, the Promise for Antibiotics and Therapeutics for Health (PATH) Act would permit the FDA to accelerate an antibacterial drug’s approval for an identifiable, limited patient population upon determining that the drug treats a serious or life-threatening condition and addresses an unmet need. In addition, the bill requires a drug’s label to include special designation from FDA indicating their intended use in limited, high-risk populations approved under this pathway. The bill also calls for further guidance and potential expansion to other appropriate therapeutic areas.
“Antibiotic-resistant bacteria pose serious and unique challenges to health care professionals,” said Bennet. “This bill will allow new antibiotics that show promise combating these bacteria to reach patients more quickly and save lives. It also will encourage bioscience companies to invest in innovative research to develop these lifesaving drugs.”
“By addressing antibiotic-resistant bacteria, we can make major strides in preventing a significant number of illnesses and deaths in the U.S.,” said Hatch. “The PATH Act is needed to spur the innovation of new antibiotics and give patients with unmet medical needs access to important antibiotics faster.”
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 resistance continues to cost tens of thousands of lives in the U.S. each year, less than 10 new antibiotics have made it to market since 2000. Antibiotic-resistant bacteria also is a significant concern to American troops, affecting more than a third of returning Iraq and Afghanistan veterans, according to the Department of Defense.