Sens. Michael Bennet, D-Colo., and Orrin Hatch, R-Utah, have introduced legislation to establish a new limited population antibacterial drug approval pathway for drugs to treat serious or life-threatening infections where there is an unmet medical need for appropriate treatments.
The Promise for Antibiotics and Therapeutics for Health (PATH) Act will allow drugs to be studied in smaller clinical trials and approved for the limited number of patients that need them. Under current law, urgently-needed antibiotics for deadly and resistant infections are not being developed because large clinical trials are not feasible as the infections occur in a small number of patients.
“Patients are dying from multidrug-resistant infections, and we desperately need new antibiotics to save their lives,” Infectious Diseases Society of America (IDSA) President Stephen Calderwood, MD, said in a statement. “The PATH Act will create a feasible approval pathway that will allow these drugs to be brought to market.”
In a report released in September, the President’s Council of Advisors on Science and Technology (PCAST) recommended that legislation be enacted to establish a new approval pathway for antibiotics for these smaller patient populations.
“There is clear agreement among medical, scientific and public health leaders that the federal government must act to stimulate development of urgently needed new antibiotics,” Calderwood said. “There is broad support for the limited population antibacterial drug pathway, which the PATH Act would establish. Congress must continue the momentum driving this issue on behalf of patients.”
The legislation will help ensure that the newly-developed drugs are used appropriately to limit the development of resistance, Calderwood added.