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September 2, 1983

'Contaminated' plasma: no automatic recall

JAMA. 1983;250(9):1126-1127. doi:10.1001/jama.1983.03340090004002

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Months after donating plasma, the donor comes down with acquired immune deficiency syndrome (AIDS) or symptoms that suggest it. Should the federal government recall that batch of plasma?

The National Hemophilia Foundation thinks it should. On the other hand, the four commercial manufacturers that are licensed to market antihemophilic factor (AHF) in the United States maintain this could jeopardize the supply of AHF, which experience has shown to be life-saving treatment for many hemophiliacs.

In a hastily-called mid-July meeting, the question was put to the seven-member Blood Products Advisory Committee of the National Center for Drugs and Biologics of the Food and Drug Administration. After considerable debate, the committee, with the help of several extra advisors, said a mechanism for a recall should not be instituted at this time.

Reaching the decision was not easy. Committee members were clearly unhappy at the thought that even one unit of plasma from