A bill surfaced in the final days of the current Congress with bipartisan support to ease regulatory requirements to get drugs that treat antibiotic-resistant bacteria approved, and it is expected to also be considered by the new Congress in January.
That expectation of it resurfacing next year “demonstrates their commitment to this issue,” said Amanda Jezek, vice president of public policy and government relations at the Infectious Diseases Society of America.
The legislation, introduced Wednesday by Sens. Michael Bennet (D-Colo.) and Orrin Hatch (R-Utah), calls for a new drug approval pathway that would streamline how these drugs are brought to market, in part by narrowing the patient population used in clinical trials. That would lower costs for manufacturers, making the trials more financially feasible, advocacy groups say.
The legislation would give the Food and Drug Administration the authority to use this pathway to approve new antibiotics, which is expected to speed up the process of getting drugs on the market. Another bill, similar to the one introduced this week, is in the House.
“We feel there's really strong momentum” in support of improving the way that antibiotics are approved, Jezek said.