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Michael Phelan
Michael Phelan
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FDA Rank and File Do Not Support Preemption

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Yesterday the U.S. House Committee on Oversight and Government Reform issued a report saying FDA career staff objected to a change in preemption rules, even saying the central factual justifications for the agency’s new positions were false. The report highlights internal FDA documents which show high-ranking career officials repeatedly warning about the dangers of not allowing drug companies to add additional warnings to their labels without FDA approval. Prior to this the FDA had asserted through a rule on drug and device labeling that manufacturers should not be held accountable for failing to update their label with additional risks, if the original label was approved by the FDA.

The report cites Dr. John Jenkins, the highest official in FDA’s new drug review process, writing:

" [M]uch of the argument for why we are proposing to invoke preemption seems to be based on the false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis. We know that such an assumption is false.”

Prior to the rule being issued one FDA career official asserted that the rule “is not as it purports to be, consistent with the agency’s role in protecting the public health…”

A copy of the report can be found at http://oversight.house.gov/documents/20081029102934.pdf . My friend, Brooks Schuelke, has also written an important blog on this topic and has written a series of blogs on the White House’s attempt to ram complete preemption down the throats of the public and the states.

The Bush Administration continues to push for federal agencies to support the concept of preemption, even in the face of dissent from agency insiders who know best how the agency functions. Contrary to the view of the White House and the FDA general counsel (an administration stooge), the drug regulators said pharmaceutical manufacturers could not be trusted to warn patients of new risks. The concept of preemption, as it is being pushed by the administration, violates principles of states’ rights and citizens’ rights to trial by jury as set forth in the Seventh Amendment.