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Blood Banking and Regulation: Procedures, Problems, and Alternatives
talk about blood, a way that is not kidding ourselves and kidding consumers. It is a risk-versus-benefit criterion, not a cost criterion. If you apply absolute safety, you are going to apply unlimited costs, and if you apply unlimited costs, then the heavy hand of FDA will make these products disappear. I do not know anyone who wants to see the United States without a blood supply, although that, in fact, is where we are headed if absolute safety is the paradigm that we are going to choose.
THE PUBLIC VIEW
Question from the Audience: The language of safety is somewhat misleading. Everyone knows that when we talk about automobile safety we are not completely safe. I am not sure we are as well informed about blood.
Mary Pendergast: For some FDA products the standard of safety is higher. For pesticides for foods that kids eat, the U.S. consumers want absolute safety. As for blood, U.S. consumers want absolute safety. We as regulators and you as industry and academics have helped to perpetuate that. It may be time to change the debate. There has never been an FDA official who has stood on Capitol Hill and said, ''This drug is safe." Nobody ever says that. They always say that the benefits of this drug outweigh the risks. I know that the statute says "safe and effective," but you can only think of safety relatively. We are able to make the debate in some areas, but we have not made it in all areas.
Question from the Audience: You mentioned both the value of diverse opinions being expressed and an interest in continuing the dialogue. In what venues should that dialogue occur other than through the new BPAC and the coalition?
Mary Pendergast: It is fair to say that this has been our most fully debated issue. It is the nub of the question and is the toughest thing that we must deal with. I cannot yet tell you what we are going to do. Any suggestions are welcome.