Blood Safety Recommendations - August 1998
DATE: September 5, 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 August 28, 1998
1. The Advisory Committee recommends that the Department of Health and Human
Services take steps to accelerate the transition from plasma derivatives to
their recombinant analogs where medically appropriate.
2. The Advisory Committee recommends that the Department of Health and Human
Services support research to develop alternatives to plasma-based technologies
for diseases such as the immunodeficiencies, alpha-one antitrypsin deficiency,
and von Willenbrand's disease, where these alternative technologies have not
yet matured.
3. The Advisory Committee recommends that the Department of Health and Human
Services maintain and as necessary expand or intensify surveillance of blood
donors and recipients for existing and emerging transmissible diseases.
4. The Advisory Committee directs its staff to develop options to be presented
to the Blood Safety Director for the creation of a sentinel system to monitor
production, demand, and utilization of blood products and to create projections
for future demand.
5. The Advisory Committee recommends that the Secretary of Health and Human
Services direct the Health Care Financing Administration and other appropriate
agencies to explore strategies to ensure that all patients have access to adequate
reimbursement for recombinant technologies, and to report to this Committee
in a timely manner.
6. The Advisory Committee recommends that the Secretary examine innovative
responses, including regulating the import and export of plasma and finished
products, in order to ensure a safe and adequate supply of plasma derivatives
and recombinant products for American user communities.7. The Advisory Committee
encourages further efforts to develop and communicate standards for the prophylactic
and therapeutic use of clotting factors and other blood derivatives.
8. The Advisory Committee urges the Secretary to convene a meeting of manufacturers
of plasma derivatives and their recombinant analogs to discuss strategies for
distribution in light of shortages.
FOLLOW-UP
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