If a device manufacturer commits fraud on the FDA, puts a device out there, and injures people--but, they cannot sue and can't get discovery to get at these documents, then you will never know whether or not they committed fraud on the FDA or not.
Harkin emphasizes the lack of accountability for manufacturers committing fraud against the FDA.
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I wish to thank Chairman Harkin for his superlative service to the State of Iowa and to our Nation for more than four decades.
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