July 1998
Links to Other ASM Pages:
Public Affairs Report
ASM Submits Comments to FDA on Medical Device Exemptions
On May 4, the ASM sent a letter to the Food and Drug Administration recommending the FDA remove eleven Class I devices from the list of exempted Class I devices and place them on the Reserved Class I Devices list as published in the Federal Register on February 2, 1998. The Subcommittee on Microbiology Devices of the Public and Scientific Affairs Board reviewed the published list and strongly encouraged the FDA to exempt an additional eleven in-vitro diagnostic devices and serological reagents due to potential public health hazards if exempted. The eleven devices and reagents proposed for exemption are used to detect and diagnose high risk infectious diseases and therefore do meet the reserved criteria under section 206 of the Food and Drug Administration Modernization Act of 1997 and therefore should not be exempt from premarket notification. The letter can be found on the ASM Home page at http://www.asmusa.org/pasrc/fdaclass1.htm
ASM and Coalition Write to Congress in Support of CLIA 88
The Coalition to Preserve Safe Patient Testing, of which ASM is a founding member, sent a letter to Congress in opposition to H.R. 2250, the Clinical Laboratory Improvement Act Amendments of 1997. This legislation, if enacted, would exempt physician office laboratories (POLs), 56 percent of all laboratories in the United States, from any federal oversight. CLIA establishes minimum standards for laboratories performing patient testing. One of the basic tenets of the law is that all testing facilities, regardless of location, should follow accepted laboratory quality practices when performing patient testing. The Coalition letter mentioned a study recently published in the Journal of the American Medical Association which clearly indicate the need for regulating POLs. The study, conducted by the California Department of Health and the Centers for Disease Control and Prevention (CDC), evaluated the proficiency testing (PT) performance of laboratories. The study demonstrated that laboratory testing in previously unregulated facilities is not as accurate as testing performed by previously regulated laboratories, such as hospital and commercial facilities. In fact, the California study shows that POLs have three times the unsatisfactory rate than other laboratories.
The following organizations, in addition to the ASM, signed onto the letter; American Association for Clinical Chemistry, American Association of Bioanalysts, American Clinical Laboratory Association, American Medical Technologists, American Society for Clinical Laboratory Science, American Society of Clinical Pathologists, Association of State and Territorial Public Health Laboratory Directors, Clinical Laboratory Management Association, International Society for Clinical Laboratory Technology and Public Citizen. A full copy of the letter can be found at http://www.asmusa.org/pasrc/coalition.htm
ASM Recommends National Policy for Congressional Science Study
On May 6, the ASM submitted policy recommendations to the House Science Committee's National Science Policy Study. The Science Policy Study, Chaired by Science Committee Vice Chairman Vernon Ehlers (R-MI), is reviewing the United States’ national science policy and will develop a new long-range science and technology policy. This study is being conducted at the request of the Speaker of the House, Newt Gingrich (R-GA), in an effort to provide direction to the nation’s science policy in the post cold war era. More information on the study is available from the House Science Committee at http://www.house.gov/science/science_policy_study.htm. A copy of the ASM’s recommendations is available on the internet at http://www.asmusa.org/pasrc/sciencepolicy.htm
ASM Urges Congressional Support for FDA Research
On April 15, ASM sent a letter to Senator’s Gramm (R-TX), Frist (R-TN), Domenici (R-NM), and Lieberman (D-CT) urging that the FDA’s Center for Biologics Evaluation and Research (CBER) program be included in any upcoming authorization measures to double or significantly increase federal support for scientific research. The ASM is concerned that the level of funding for FDA’s CBER research activities essential to the Agency’s mission has been in serious decline and has eroded the science base at the FDA. In order to protect and enhance the public health through regulation of biological and related products such as blood, vaccines and other biological therapeutics, CBER requires adequate scientific resources.
ASM – Brookings Sponsor Biological Weapons Defense Forum
ASM sponsored a forum on Biological Weapons Defense with the Brookings Institution at Brookings on April 27. Participants in two panel presentations surveyed the basic military and biological nature of the threat of biological weapons, ongoing efforts to limit the threat (including a strengthened Biological Weapons Convention), and ways the United States might respond to any use of biological weapons against its military forces or civilian population. Dr. Ronald Atlas, Co-Chair of the ASM’s Task Force on Biological Weapons Defense made an oral presentation on issues surrounding the biological nature of the threat of biological weapons.
ASM Recommends Increased Funds for Defense Infectious Disease Research
On May 4, the ASM sent a letter to Congressman Bill Young (R-FL), Chairman, House Appropriations Subcommittee on National Security and Senator Ted Stevens (R-AK), Chairman, Senate Subcommittee on Defense Appropriations urging Congress to increase funding for the Department of Defense (DoD) Infectious Disease Research Program. DoD research in the Military Infectious Disease Research Program encompasses the development of vaccines against militarily important diseases, discovery and development of prophylactic and treatment drugs for parasitic infectious diseases, techniques for rapid identification of disease organisms and diagnosis of infections, collection and analysis of epidemiological data that aid in control of relevant infectious diseases, and studies of control measures against infectious disease vectors. The full text of the ASM’s letter is available at http://www.asmusa.org/pasrc/dodfunding.htm
Cassell Attends Joint FDA – CDC Meeting on Antimicrobial Use
On May 6, Gail Cassell, Chair of the ASM’s Public and Scientific Affairs Board participated in a joint meeting sponsored by the Food and Drug Administration, Center for Veterinary Medicine (FDA-CVM) and the Centers for Disease Control and Prevention, National Center for Infectious Diseases (CDC/NCID) on the "Development of a Prudent Use Plan for Therapeutic Antimicrobials in Veterinary Medicine." The meeting brought together relevant stakeholders, including representatives from the human medical community to discuss these important issues. The FDA and the CDC organized the meeting as a first step in the dialogue necessary to promote prudent use principles for antimicrobials. The ASM Task Force on Antibiotic Resistance, Chaired by Dr. Cassell, issued a report in 1994 which made recommendations concerning the emergence of antibiotic resistance research needs, surveillance strategies and public education. The report is available on the ASM web site at http://www.asmusa.org/pasrc/reports.htm
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