The Zika ThreatASM Acts to Counter Zika Virus Outbreak.
The past year was an unprecedented time of fiscal conflict during which ASM made every effort to ensure that research and public health program funding levels were not dramatically reduced. The following are some examples of ASM efforts to avert draconian cuts in research budgets and to advocate for increased funding:
The ASM worked with numerous coalitions to influence policy related to science, public health and the clinical laboratory. As a direct result of the advocacy efforts, the FY 2011 budget for science did not include the steep reductions in H.R. 1. The FY 2012 appropriations bills provided modest increases for science, including a 3% increase for NSF.
The year ahead for FY 2013 budgets will be a difficult one. The August 2011 debt limit agreement, PL 112-25, set a discretionary spending limit of $1.047 trillion for fiscal year 2012. The Joint Deficit Reduction Committee failed to reach an agreement on budget savings, which means that federal spending faces $1.2 trillion in automatic cuts to nondefense and defense spending in January 2013. The science advocacy community including ASM continues to play a critical role in sustaining funding for research and public health.
The ASM endorsed the launch of a new campaign, Antibiotic Action, created by the British Society of Antimicrobial Chemotherapy to raise awareness about the creation of new antibiotics and the problem of multi-drug resistance. Read the American Society for Microbiology Supports Antibiotic Action Campaign press release.
In July, the ASM sent a letter to the U.S. House of Representatives in support of H.R. 2182 , the Generating Antibiotic Incentives Now (GAIN) Act of 2011. This bipartisan legislation was written with the goal of encouraging greater antibiotic drug development. The letter commended and agreed with the intent of the GAIN Act and made several suggestions for improving the legislation.
Susan Sharp, Chair of the Laboratory Practices Committee of the PSAB, Ron Atlas, Cochair of the PSAB Biodefense Committee, Amy Chang and Janet Shoemaker at ASM worked with CDC at their request for ASM assistance with a survey in response to an outbreak of Salmonella Typhimurium infections associated with exposure to microbiology laboratories in teaching and clinical settings. Illnesses were identified among students in microbiology teaching laboratories and employees in clinical microbiology laboratories who reported working with Salmonella bacteria. The survey was sent to institutions including classroom laboratories and clinical laboratories. The ASM is following up with CDC for biosafety issues for teaching laboratories.
The PSAB Committee on Biomedical Research, chaired by Gail Cassell, submitted comments to the Advisory Committee to the NIH Director’s working group which is examining the future of the biomedical research workforce in the United States. The PSAB solicited input from members involved in Ph.D., M.D., or Ph.D./M.D. research training programs and requested comment on a list of issues identified by the NIH Working Group and the PSAB. Queries were sent to microbiology and immunology department chairs and principal investigators of NIH institutional training grants, and other ASM members requesting observations related to the microbial and immunological sciences. Read the ASM/PSAB comments on the ASM Policy website. The ASM PSAB will be discussing training issues with NIH.
OSTP Initiative on Bioeconomy
Mike Doyle, chair of the PSAB Committee on Agricultural and Food Microbiology and Chuck Rice, committee member, met with Catherine Woteki, Under Secretary for Research, Education and Economics (REE) at the USDA. The meeting focused on REE microbiology programs as well as those housed within the National Institute of Food and Agriculture (NIFA) and the Agriculture and Food Research Initiative (AFRI.) Also discussed were funding issues in FY 2011 and those upcoming for FY 2012 and beyond. The ASM recommendations for USDA microbiology research here.
In February, members of the PSAB Committee on Environmental Microbiology, chaired by Gary King, approved the endorsement of a coalition letter supporting FY 2012 funding for a national groundwater monitoring network. The letter was sent to House and Senate Interior, Environment and Related Agencies subcommittee members and urged Congress to support $10 to $50 million of additional funding in the FY 2012 US Geological Survey Ground Water Resources Program.
The ASM co-sponsored a congressional briefing on how the nation’s investment in the National Institutes of Health (NIH) is fostering scientific discoveries. The briefing focused on the role that NIH and the National Institute of Allergy and Infectious Diseases (NIAID) have played in addressing health challenges such as HIV/AIDS and influenza. For more than 60 years, NIAID research has led to new therapies, vaccines, diagnostic tests, and other technologies that have improved the health of millions of people in the United States and around the world. Anthony Fauci, M.D., Director, National Institute of Allergy and Infectious Diseases, NIH spoke at the briefing on December 6.
The ASM sent a letter to the Office of Government Ethics (OGE) saying it supports the proposed rule which would permit government scientists to serve in their official capacity in the governance of nonprofit organizations. The OGE issued a proposed rule on May 3 which would allow federal employees to serve in their official capacity as officers, directors and trustees of nonprofit organizations, even though such service could give them authority over the financial interests of those organizations. Under the current law, there is a general prohibition against this, unless an agency has given the employee a specific waiver permitting such service.
A small sample of the issues that the CLP and PAC committees have undertaken in 2011 include working with CMS for withdrawal of the physician’s signature requirement and the payment methodology for new laboratory codes; statements to the FDA on guidance on laboratory developed tests (LDTs) and Diagnostic Products Labeled for Research Use Only (RUO) or Investigational Use Only (IUO), and the reclassification of M. tuberculosis molecular diagnostic tests. Committee members also revised the Sentinel Laboratory Guidelines for Suspected Agents of Bioterrorism and Emerging Infectious Diseases for Packing and Shipping Infectious Substances and assisted CDC with a survey in response to an outbreak of Salmonella infections associated with exposure to microbiology laboratories in teaching and clinical settings. ASM also sent letters to key Congressional leaders opposing the proposed implementation of Medicare Part B coinsurance on clinical laboratory services as part of the debt ceiling negotiations. Details of these activities follow.
Professional Affairs Committee members participated in the revision (PDF) of the Sentinel Laboratory Guidelines for Suspected Agents of Bioterrorism and Emerging Infectious Diseases for Packing and Shipping Infectious Substances.
The ASM sent letters to key Congressional leaders opposing the proposed implementation of Medicare Part B coinsurance on clinical laboratory services as part of the debt ceiling negotiations.
The Centers for Medicare and Medicaid Services (CMS) held a meeting July 18 to hear public recommendations on the assignment of payment levels for new Current Procedural Terminology (CPT) laboratory codes. These codes will be included in the 2012 Medicare Clinical Laboratory Fees Schedule. Vickie Baselski, chair of the Professional Affairs Committee of the ASM Public and Scientific Affairs Board (PSAB), addressed the panel with fee recommendations for codes for HIV antibody and combined HIV antigen-antibody tests. A detailed rationale for ASM’s recommendations for the proposed fees can be found online (PDF).
The FDA Microbiology Devices Panel of the Medical Devices Advisory Committee met Jun 29 to discuss the possible reclassification of nucleic acid amplification test (NAAT) rapid M. tuberculosis (MTB) diagnostics and the classification of Interferon Gamma Release Assays (IGRAs). Melissa Miller, a member of the Committee on Laboratory Practices, addressed the panel in support of the reclassification of molecular diagnostic devices for detection of M. tuberculosis from PMA approval to 510(K) clearance. The Microbiology Device Panel’s overall consensus was that FDA should consider reclassifying molecular diagnostics for rapid detection of M. tuberculosis complex directly from patient specimens. Documents related to the Microbiology Devices panel meeting can be found online here.
ASM hosted an FDA Roundtable meeting October 8 for laboratory stakeholders. Speakers discussed updates to laboratory developed test regulations and the CDRH Plan of Action for the 510(k) program and changes in RUO/IUO marketing practices and In Vitro Companion Diagnostics guidance. Some of the organizations represented at the roundtable were the American Association for Clinical Chemistry (AACC), the American Society for Clinical Pathology (ASCP), the Association for Molecular Pathology (AMP), the American Medical Technologists (AMT), the Association of Public Health Laboratories (APHL), and the College of American Pathologists (CAP).
The Centers for Medicare & Medicaid Services (CMS) will withdraw the rule that requires a physician’s signature on all paper requisitions for clinical diagnostic laboratory tests that are reimbursed by the Clinical Laboratory Fee Schedule (CLFS). The ASM worked with the Clinical Laboratory Coalition (CLC) to have the rule revoked because the ramifications for clinical labs. Due to the efforts of ASM members and other CLC organization members the CMS announced on February 11, 2011 that the rule is unworkable and will work with the clinical laboratory community if a new rule is considered. Copies of the House letter, which was signed by 89 representatives and the Senate letter, signed by 34 senators are available by clicking the links above.
Representatives of the ASM Public and Scientific Affairs Board were invited to meet with the Federal Experts Security Advisory Panel (FESAP) on July 21 to discuss the Panel’s recommendations, which have been provided to the Select Agent Program, to focus higher personnel and physical security requirements on 11 agents considered to be the most dangerous pathogens and to remove about 25 agents and toxins from the Select Agent list. PSAB Biodefense Committee Chairs Ronald Atlas and Kenneth Berns and Janet Shoemaker attended the meeting. The Federal Experts Security Advisory Panel (FESAP) released its recommendations concerning the Select Agent Program on June 14.
The PSAB Committee on Biodefense prepared written comments on the Department of Health and Human Services and the US Department of Agriculture Notices of Proposed Rulemaking (NPRM) which were published in the October 3, 2011, Federal Register, to amend and republish the list of select agents and toxins that have the potential to pose a severe threat to animal or plant health, or to animal or plant products.
The NIH Office of Biotechnology Activities (NIH OBA) invited ASM to participate in and serve on the planning committee for their recent biennial conference that focused on biosafety issues and Institutional Biosafety Committee (IBC) oversight of laboratory research involving emerging technologies. The program was targeted towards IBC members and staff, biosafety professionals, research administrators, scientists, regulators and others involved in the conduct and oversight of research.
During the asm2011 General Meeting in New Orleans, LA the 10 awardees of the ASM General Meeting Minority Travel Grant were honored at a reception. The ASM General Meeting Minority Travel Grant program offers travel grants to increase the participation of underrepresented minority (URM) groups in the ASM General Meeting. The reception was organized by the Committee on Microbiological Issues Impacting Minorities (CMIIM), chaired by Dr. Marian Johnson-Thompson. The CMIIM developed the grant program for ASM and has submitted a renewal request to the NIAID. Information on the grant is available here.
The Committee on the Status of Women in Microbiology (CSWM) hosted a reception at the 2011 General Meeting which honored the 2011 Roche Diagnostics Alice C. Evans Award, Susan Forsburg, Ph.D. of the University of Southern California. The award was presented by CSWM Chair, Lorraine Findlay.
ASM Selects Congressional Science Fellow for 2011-2012
The American Society for Microbiology awarded its 40th Congressional Science Fellowship to Carolyn Dong Shore in September of 2011. Carolyn will work on the staff of Representative Louise Slaughter (D-NY) during her fellowship year.
Go to the PUBLIC POLICY web page to learn more about the Public and Scientific Affairs Board and its activities.
Developed to help laboratories understand how to accurately and rapidly identify V. cholerae. This document was drafted by Barbara Robinson-Dunn and Christopher Doern and reviewed by the PSAB Committees on Laboratory Practices and Professional Affairs.
C. gattii has emerged as an important cause of cryptococcosis in the Pacific Northwest region of the U.S. This document outlines the epidemiological and clinical differences between C. gattii and C. neoformans, and indicates the laboratory tests that can be used for the differentiation of these two organisms. This document was drafted by Susan Butler-Wu and Ajit Limaye and reviewed by the PSAB Committees on Laboratory Practices and Professional Affairs.