IDSA Applauds New Legislation Aimed at Developing Drug Approval Pathway

The Infectious Diseases Society of America (IDSA) applauds Senator Michael Bennet (D-CO) and Orrin Hatch (R-UT) for introducing the Promise for Antibiotics and Therapeutics for Health (PATH) Act, legislation to establish a new limited population antibacterial drug approval pathway for antibacterial drugs to treat serious or life-threatening infections where there exists an unmet medical need.

“Patients are dying from multi-drug resistant infections, and we desperately need new antibiotics to save their lives.  The PATH Act will create a feasible approval pathway that will allow these drugs to be brought to market,” explains IDSA president Steve Calderwood, MD, FIDSA.

Under current law, many of the most urgently needed antibiotics to treat some of the most deadly and highly resistant infections are not being developed because companies cannot fill large, traditional clinical trials as these infections currently occur in a relatively small number of patients. But we need to start developing drugs to treat these infections before greater numbers of patients become ill.  The PATH Act will allow these drugs to be studied in smaller clinical trials and approved for the limited population of patients who need them.

“Importantly, the PATH Act will not only help spur the development of urgently needed new antibiotics.  The legislation will also help ensure these precious new drugs are used appropriately to limit the development of resistance,” says Calderwood.  Specifically, the PATH Act requires clear labeling of drugs approved under this pathway (through a logo or other such means), pre-review of marketing materials, and monitoring the use of drugs approved under this pathway, as well as patterns of resistance.

In its September report, the President’s Council of Advisors on Science and Technology (PCAST) explicitly recommended the enactment of legislation to establish a new approval pathway for antibiotics to be used in limited populations of patients.  “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.  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.  IDSA looks forward to working with Senators Bennet and Hatch to enact the PATH Act,” Calderwood adds.

Source: IDSA