Blood Safety Recommendations - April 1998
DATE: May 8, 1998
TO: Interested Parties
FROM: Stephen Nightingale, MD, Executive Secretary
Advisory Committee on Blood Safety and Availability
SUBJECT: Recommendations of the Advisory Committee on April 28, 1998
The following recommendations were unanimously adopted by the Advisory Committee
on April 28, 1998. The Chairman and members have subsequently approved the
following text to be the official statement of these recommendations. A transcript
of the Committee's deliberations has been posted on the Committee's web site
(http://www.hhs.gov/partner/Blood Safety). For additional information please
contact me at the Department of Health and Human Services, Office of Public
Health and Science, 200 Independence Ave. S. W., Room 736E, Washington, DC
20201, telephone (202) 690-5560.
I RECOMMENDATIONS FOR THE SHORT TERM
1. The Food and Drug Administration, the International Plasma Producers Industry
Association, and individual manufacturers and distributors of plasma derivatives
and their recombinant analogs should, on a monthly basis, collect and disseminate
standardized information on production, distribution, and demand for intravenous
immunoglobulin, clotting factors (recombinant and plasma-derived), and alpha-1
antitrypsin.
2. The Department of Health and Human Services should explore, in collaboration
with industry, health care providers, and appropriate consumer groups, methods
to optimize and standardize allocation of available products in an equitable
manner, including management of emergency supplies and programs that distribute
products directly from manufacturers to registered consumers.
3. Industry should discuss triage of specific plasma derivatives to specific
patient groups with the Food and Drug Administration, the Federal Trade Commission,
health care providers, and appropriate consumer groups in order to promote
accountability to the public of these practices.
4. Industry should explore with the Food and Drug Administration the possibility
of importing additional supplies of intravenous and intramuscular immunoglobulin
preparations.
5. Industry should explore with the Food and Drug Administration strategies
for reallocating partially processed plasma materials from one manufacturer
to another in order to optimize production of alpha-1 antitrypsin and other
plasma derivatives.
6. Industry should explore with the Food and Drug Administration labeling
and disclosure strategies which would increase product availability without
compromising public safety and trust.
7. Industry and government should explore the impact of a temporary decrease
in exportation of plasma derivatives while they are in short supply in the
United States.
II RECOMMENDATIONS FOR THE LONG TERM
1. Every effort should be made to make recombinant clotting factors available
to all who would benefit from them, and all barriers to conversion from human
to recombinant clotting factors should be removed.
2. The National Institutes of Health should convene a Consensus Conference
on the use of recombinant clotting factors for patients with bleeding disorders.
3. Industry should explore strategies for the development of reserve supplies
of plasma derivatives and for their allocation during shortages.
4. The National Institutes of Health and industry should immediately evaluate
alternative dosage schedules and alternative delivery systems for alpha-1
antitrypsin therapy, including prophylaxis strategies and strategies for treatment
during acute exacerbations of disease, and accelerate the development of gene-based
products and gene-directed therapies for alpha-1 antitrypsin deficiency.
5. The National Institutes of Health and industry should support the continued
evaluation of the use and appropriate dose of intravenous immunoglobulins
for indications where its benefit requires further delineation, and the results
of these evaluations should be rapidly disseminated to the public.
6. Industry should work with the Food and Drug Administration to expand capacity
sufficiently to meet anticipated demand for plasma derivatives.
7. Industry and government should jointly explore the antitrust implications
of efforts to share data in order to prevent shortages.
FOLLOW-UP
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