October 6, 2015 - ASM Letter in Response to the Antimicrobial Resistance Rapid Point of Care Diagnostic Test Challenge
The Department of Health and Human Services (HHS) is holding a prize competition in which up to $20 million will be made available, subject to the availability of funds, for the delivery of one or more successful rapid point-of-care diagnostics that may be used by health care providers to identify bacterial infections. The National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA) are sponsoring the prize competition and invited public comments regarding the technical criteria and performance characteristics of the diagnostics for which the prize will be offered. The development and use of rapid, point-of-care, and innovative diagnostic tests for identification and characterization of resistant bacteria was a goal identified in the National Strategy for Combating Antibiotic-Resistant Bacteria released in September 2014 and addressed in the National Action Plan for Combating Antibiotic-Resistant Bacteria released in March 2015.The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are contributing technical and regulatory expertise to develop the award evaluation process.
The ASM sent a letter to Turing Pharmaceuticals regarding the company’s recent 5,000 percent cost increase for the decades old generic drug pyrimethamine (Daraprim).
The ASM sent a letter to Representatives Boustany and Thompson regarding their proposed Antibiotic and Rapid Diagnostic Research and Development Tax Credit Act of 2015. The legislation is designed to accelerate discovery of novel tools against drug resistant microbial pathogens.
The September issue of the Minority Microbiology Mentor has been published by the Committee on Microbiological Issues Impacting Minorities.
Announcement of Public Consultation on Antimicrobial Resistance Rapid, Point-of-Care Diagnostic Test Challenge
As a part of the National Strategy for Combating Antibiotic-Resistant Bacteria the U.S. Department of Health and Human Services (HHS) announced a prize competition for the delivery of one or more successful rapid point-of-care diagnostics that may be used by health care providers to identify bacterial infections.
The ASM submitted questions to the Administrator of the Centers for Medicare and Medicaid Services (CMS) on the implementation of Individualized Quality Control Plans (IQCPs) in the clinical microbiology laboratory. The answers sought will allow ASM to assist clinical microbiologists prepare for implementation of their own IQCPs by the deadline of January 2016.
The September issue of the e-Public Policy Update has been published by the Office of Public Affairs.
The ASM submitted comments to the Centers for Disease Control and Prevention on the possession, use, and transfer of select agents and toxins. The comments addressed adding certain Influenza virus strains to the List of Select Agents and Toxins.
The ASM submitted comments to the National Institutes of Health (NIH) RFI on the Framework for the NIH-wide Strategic Plan. The comments will help NIH develop a 5-year strategic plan to outline a vision for biomedical research that will pursue fundamental knowledge about the nature and behavior of living systems and apply that knowledge to extend healthy life and reduce illness and disability.
August 17, 2015 - ASM Comments on Department of State and Commerce Control Regulations for Certain Pathogens
The ASM submitted comments to the US Department of Commerce and the US State Department regarding the Category XIV materials (Toxicological Agents, Including Chemical Agents, Biological Agents, and Associated Equipment) included on the United States Munitions List and the Commerce Control List.