Followup
DATE: February 6, 1998
TO: Interested Parties
FROM: Stephen D. Nightingale, M.D., Executive Secretary
Advisory Committee on Blood Safety and Availability
SUBJECT: Recommendations of the Advisory Committee
on January 30, 1998
1. We recommend that the Public Health Service
coordinate an effort to develop a report within six months that will address
issues of existing and emerging transmissible spongiform encephalopathies.
The report should make specific reference to
a. Food borne transmission, particularly through consumption of central nervous system tissues;
b. Iatrogenic transmission; and
c. Transmission through transfusion of blood components and plasma derivatives.
National and international surveillance of transmission in both humans and animals, education of providers and the public, needed resources for research, prevention strategies, and efforts in other
countries also should be addressed in the report.
See Guidance to Industry: Revised Precautionary
Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease
and New Variant Creutzfelt-Jakob Disease by Blood and Blood Products. November
17, 1999. www.fda.gov/cber/guidelines.htm.
2. We recommend that the Public Health Service,
professional groups, and patient advocates emphasize the importance of postmortem
examination to the protection of the public health, and that they support
the training of physicians to recognize new pathological patterns of emerging
disease in autopsy tissues.
The Public Health Service and the other
groups mentioned already do so.
3. We recommend nationwide standardization of procedures for screening donors at risk for transmissible spongiform encephalopathies.
These standardized procedures already exist (e.g., in the Guidance cited above).
4. We recommend that the National Institutes
of Health specify its needs for research and infrastructure support necessary
to promote research on the transmissible spongiform encephalopathies, with
particular reference to human and animal tests that can discriminate among
these conditions within each species.
The National Institutes of Health will continue to do so.
5. We recommend that during the next year the
Food and Drug Administration work with industry and appropriate consumer groups
to relax current Creutzfeldt-Jakob disease guidelines on quarantine and withdrawal
of blood products to the extent necessary to relieve shortages.
See the Guidance cited above.
SDN August 3, 2000
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