On the recordSeptember 23, 1997
Amendment No. 1140, which I have offered, is an amendment that I think is absolutely essential if this bill is to be airtight. We are giving to outside laboratories the authority to review and approve medical devices, medical devices which literally could mean life or death for millions of Americans. When these approvals are given, these companies stand to make substantial profits because of FDA approval. The Durbin amendment corrects a serious error in this bill by making certain that there will be no conflict of interest by the third-party reviewers. We say in specific terms that those reviewing the medical devices cannot receive gifts from the company that is the owner of the medical device, they cannot receive or own stock of the company that they are reviewing, they cannot have been offered a job or solicited a job from the company that they are reviewing, and there must be a full financial disclosure. If we are going to maintain the integrity of the process, protect American consumers, and avoid this sort of conflict of interest, I urge my colleagues to adopt the Durbin amendment.
Source
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