Blood Banking and Regulation Procedures, Problems, and Alternatives (1996) / Chapter Skim
Currently Skimming:
IV Congressional Oversight and Regulatory Initiatives
IV Congressional Oversight and Regulatory Initiatives
Pages 91-102
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From page 91... ...
The Forum therefore invited Anne Marie Finley and Mary Pendergast to address the closing session of the September 1995 meeting, to describe the work of the Congress and of the DHHS with respect those recommendations. Their presentations continue the theme of regulatory effectiveness and regulatory reform.
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From page 93... ...
THE WORK OF THE SUBCOMMITTEE In May of 1995 the subcommittee began a general oversight investigation into blood safety issues and FDA's management of the Blood Products Advisory Committee. This investigation resulted in a letter from Chairman Shays to FDA Commissioner David Kessler requesting that the agency not accept the June 23rd recommendation of the Blood Products Advisory Committee (BPAC)
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From page 94... ...
Additional issues that concern the subcommittee and that may come up at blood investigations and hearings include emerging infectious agents in the blood supply, the status of antigen test kit reviews, reconstitution of the Blood Products Advisory Committee, and hepatitis C virus transmission through blood and blood products. There is a strong possibility that the way in which we regulate blood and blood products will change not only at the agency and department level but possibly through congressional and public interest as well.
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From page 95... ...
We were concerned that the antigen testing issue at BPAC was, in fact, decided on some other basis. Whether that resulted from improper instruction with regard to what the criteria were or whether the agency felt that it needed to address the concerns about costs, we cannot say, but we did not feel that it was appropriate for the agency to allow the decision to be based solely on an advisory committee process that we thought reached its result on the basis of cost.
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From page 96... ...
Can you describe how an advisory committee ought to work? Anne Marie Finley: The Chairman recommended in his letter to Commissioner Kessler that BPAC be disbanded and that we start again with a national advisory committee on the safety of the blood supply.
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From page 97... ...
~ again, goes lo tbe consumer conAdence bsue. Pe~aps ~ by a greater voting membership on the pad of the public.
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From page 99... ...
THE TASK FORCE CHARGE Our charge is to respond to each of the recommendations made by IOM that might have moderated some of the effects of the AIDS epidemic. Because IOM had also urged the government and private organizations responsible for blood safety to evaluate their current policies and procedures to see if they fully addressed the issues raised by the recommendations, we are doing that as well.
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From page 100... ...
We had asked IOM to help us some years ago on our advisory committees, because one of the things David Kessler and I have been trying to do is make the agency more of a unitary organization. We have different product centers-that sometimes operate with different plans, projects, and attitudes.
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From page 101... ...
COST AS A FACTOR With respect to whether cost is a factor, I do not think that it is, but it is also naive to think that absolute safety can be a reality. No product that FDA regulates, whether it is milk or human genome products, biotechnology, medical devices, or old-fashioned chemical drugs, is absolutely safe.
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From page 102... ...
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.
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