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Tuesday, April 08, 2008


Stephen Dolle

Though FDA does require a 6 to 8 year submission and review period prior to issuing a PMA (pre market amendment) for a new drug or medical device, and to which the PMA process as opposed to the lesser regorous 510k filing, inevitably turned the USSC's decision on premption in Medtronic's favor (Riegel v Medtronic), the reality is that FDA relies to a significant degree on the mfr's HONEST submission of its clinical data and findings. With state premption for any culpability as to misrepresentations in PMAs now having been removed, mfr's will become more enboldened to mislead FDA. And with FDA having budget and resource limits, this raises the liklihood that knowingly unsafe drugs and devices will reach the market. It seems plausible that 17200 claims could be instead used in certain cases where mfr' "intentional deceit" rises to such a threshhold. As a scientist, I look to the legal experts to discern this.

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