Hot topic these days is pre-emption. Think of it as complete immunity for drug companies. The american association of Justice (AAJ) just released some blockbuster news about a Bush Administration plot. There press release follows:
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 House 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 .
The Associated Press story on the issue is also informative. You can read it at: http://ap.google.com/article/ALeqM5h1C2M6_6XJkirIrtYpwjP_02a2pAD944G96G3
