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IDSA, Pew Charitable Trusts Support Regulatory Pathway for Antibiotic Development
The Infectious Diseases Society of America (IDSA) and The Pew Charitable Trusts today hailed increasing bipartisan support in Congress to spur antibiotic development and meet the needs of patients facing the growing threat of drug-resistant pathogens. According to chief sponsors Reps. Phil Gingrey (R-GA) and Gene Green (D-TX), 12 more of their House colleagues have signed onto the Antibiotic Development to Advance Treatment Act (ADAPT) as cosponsors.
“The complex problem of antibiotic resistance requires substantial, multi-faceted action that includes policies to incentivize antibiotic development,” says IDSA president Barbara Murray, MD. “The ADAPT act is a critical step toward addressing some of the regulatory challenges in developing antibiotics for infections caused by multi-drug resistant bacteria, and without it, desperately needed new drugs will not be developed.”
ADAPT would allow FDA to approve certain new antibiotics for use after they have been studied in a fewer number of patients than is required in traditional studies. It is not feasible for antibiotics that treat serious infections due to highly resistant bacterial pathogens to be developed using traditional, large clinical trials due to the limited numbers of patients in whom these infections currently occur. This would help lower development costs and make clinical trials more feasible for developers. The new drugs would be intended for limited populations of patients with serious or life-threatening infections who do not have other treatment options.
“Antibiotic resistance is quickly outpacing the development of new drugs,” says Elizabeth Jungman, Pew’s director of drug safety and innovation. “It’s a threat we can’t afford to ignore, and we’re glad to see momentum in Congress for solutions.”
The legislation includes labeling requirements intended to communicate to physicians and other healthcare providers that these drugs have been demonstrated to be safe and effective in limited populations. While these labeling requirements are a step in the right direction, Pew and IDSA urged Congress to further strengthen them by requiring prominently placed visual elements on the labels as well, so that the need to use these drugs prudently is immediately clear.
Source: Infectious Diseases Society of America (IDSA)