Jim and Carrie Carroll at Carroll and Carroll, P.C. represent the injured people of Pennsylvania and New York in Bradford, Sullivan, Tioga, Susquehanna, and Chemung counties in personal injury, premises liability, slip and fall, automobile accident and workers’ compensation cases Jim and Carrie Carroll at Carroll and Carroll, P.C. represent the injured people of Pennsylvania and New York in Bradford, Sullivan, Tioga, Susquehanna, and Chemung counties in personal injury, premises liability, slip and fall, automobile accident and workers’ compensation cases
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    10/30/2008
    James R. Carroll, Jr., Esquire
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    U.S. House Report Further Confirms Bush Administration’s Preemption Plot

    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 .

    Associated Press story on the issue:

    http://ap.google.com/article/ALeqM5h1C2M6_6XJkirIrtYpwjP_02a2pAD944G96G3

    LA Times story:

    http://www.latimes.com/news/nationworld/nation/la-na-fda30-2008oct30,0,1783486,print.story


    Labels: fda fda, preemption


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