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.

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