CLSI has maintained the global leadership position in the area of antimicrobial susceptibility testing (AST) for humans and animals for the past 30 years. The work done by AST volunteers is core to CLSI’s mission, as the standards, guidelines, and annual M100 supplement are used to combat increasing antibiotic-resistant infections—a major threat to global public health.
Since its founding, CLSI has always maintained its core principle of including tripartite representation from health care, industry, and government professionals in technical committees and governance. Recently, the CLSI Board of Directors made a policy change stating that members from pharmaceutical companies and allied stakeholders will no longer be permitted as voting members on AST standards, guidelines, and supplements. In the organization’s continuing goal to review and refine its consensus process, CLSI has implemented this policy change due to potential issues surrounding conflicts of interest as well as to more closely align with US Food and Drug Administration (FDA) practices related to their advisory committees and other guidelines. The AST breakpoint-setting process is unique within CLSI standards development activities: within this process, decisions are made during AST document development meetings that affect the use of specifically named products in the marketplace, a situation that is unique among CLSI committees. This policy was put into effect as of January 1, 2015 for the Subcommittee on AST and will be put into effect January 1, 2016 for the Subcommittee on Antifungal Susceptibility Testing and the Subcommittee on Veterinary AST.
CLSI continues to welcome participation from representatives of pharmaceutical companies and allied supporters. These stakeholders are encouraged to continue providing their valuable and often unique expertise during AST deliberations as nonvoting members (advisors and/or technical advisors and reviewers) of a breakpoint-setting consensus committee, subcommittee, or working group. Representatives from the industry constituency that do not benefit from the sales of antibacterial products and services* may continue to participate as voting members. This approach is consistent with the FDA’s invitation of an industry representative for advisory committees.
It is an essential global public health undertaking to utilize CLSI’s open, transparent, and inclusive consensus process input from the world’s top experts. To annually update its antimicrobial breakpoints, CLSI aims to contribute in the never-ending battle of the growing resistance of microorganisms to anti-infective agents while maintaining the trust and integrity of the consensus process.
*Note that the term “antimicrobial” in this context includes anti-infectious drugs such as antibacterials, antivirals, antifungals, and antiparasitics.