November 19, 2015 - ASM Comments on Proposed Changes to Human Subject Protection Regulations (Common Rule)
ASM applauds proposed changes in the Human Subject Protection Regulations that would exclude the use of spent, de-identified human specimens for routine validation of diagnostic tests, as well as other quality assurance activities and asks that that this exclusion from oversight be expanded to include all research on de-identified specimens that do not involve analysis of human genetic material.
President Obama has proclaimed Nov. 16-22 “Get Smart About Antibiotics Week.” Get Smart Week builds on the momentum generated at the White House Forum on Antibiotic Stewardship, where more than 150 organizations pledged to improve antibiotic use and slow the spread of antibiotic resistance.
The November issue of the Minority Microbiology Mentor has been published by the Committee on Microbiological Issues Impacting Minorities.
In November members of the Committee on Microbiological Issues Impacting Minorities participated in a Hill Day. They met with their Senators and Representatives and discussed issues related to the microbial sciences and underrepresented minority scientists.
The ASM sent funding recommendations to the Committees on Appropriations for the FDA FY 2016 budget.
The November issue of the e-Public Policy Update has been published by the Office of Public Affairs.
The White House released a memorandum on the next steps to enhance biosafety and biosecurity in the United States. The memo highlights the conduct of parallel federal and broad stakeholder reviews to generate specific recommendations to strengthen the U.S. government's biosafety and biosecurity practices and oversight system.
The NIH announced that October 2015 is National Biosafety Stewardship Month (NBSM).
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).