On the recordSeptember 5, 1997
I would like to address on which I will be offering an amendment that I hope Senator Jeffords will consider is that of removing any possible money taint of the external review process. This bill expands the ability of medical device companies to purchase their own third-party reviewers. Given the importance to the public of the approval process remaining untainted by monetary influence, it is extremely important we ensure that there are very strict anticonflict of interest standards for product reviews. In laymen's terms, if we are going to hire companies to review medical devices to determine whether or not they are safe enough for sale in America, we want to make certain that the reviewers are truly objective; that they do not have any conflict of interest or any monetary gain associated with what they are doing. This bill, as currently drafted, has only very limited language on the issue of preventing conflict of interest. Senator Harkin was successful in adding some strength to that language.
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