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Executive Summary

NIH PLANS TO SEEK ALTERNATE HIVIG SUPPLIER: the National Heart, Lung and Blood Institute plans to issue a request for proposals (RFP) from facilities that could supply HIVIG for an NIH trial in HIV-infected pregnant women designed to see if hyperimmune anti-HIV intravenous immunoglobulin can prevent the transmission to the fetus of the virus that causes AIDS. NIH will provide over $1 mil. to the awardee. Abbott, which originally agreed to provide HIVIG, is deferring supplies until it receives complete indemnification against product liability. The company said it is continuing to negotiate with NIH and expects to obtain a complete waiver of product liability. The trial of HIVIG for prevention of maternal-fetal HIV transmission, AIDS Clinical Trial Group (ACTG) 185, originally was scheduled to begin in March. The NIH trial, to be conducted by NHLBI, the National Institute of Child Health and Human Development and the National Institute of Allergy and Infectious Diseases will involve 400 HIV- infected pregnant women, half of whom will receive HIVIG and half of whom will receive standard intravenous immune globulin. HIVIG is manufactured from the plasma of HIV-positive asymptomatic individuals who have CD4 cell counts over 500 and who are p24 antigen and virus negative. Production of HIVIG requires a plasma fractionation facility to inactivate HIV. NHLBI said there are noncommercial concerns -- major blood centers -- that may be willing to dedicate facilities to HIV plasma fractionation. NIH is aware of two organizations that have manufactured HIVIG. Companies developing AIDS vaccines also have expressed concerns about liability. At a July 9 technology transfer conference sponsored by the National Institute of Standards and Technology, NIH Director Bernadine Healy, MD, stated that "so many of the companies are reluctant to get into vaccines in the U.S. or Europe." She added, "We have a case now where a major pharmaceutical company has a candidate vaccine that looks very good, and they are afraid of liability. They will only let NIH try and license it to some other firm." While declining to name the company, Healy said, "We need a vaccine for HIV, and I think it's unconscionable to delay by a year, even a month, because of this kind of fear that somewhere down the road there might be a lawsuit against a vaccine." She predicted that more legislation focusing on product liability will be introduced and stressed that NIH and FDA cannot adequately address the issue alone.

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