Tom Harkin actually said...

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.

Context

Harkin emphasizes the lack of accountability for manufacturers committing fraud against the FDA.

08/03/2009

https://www.congress.gov...

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