In my view, this refutation and undermining of its own black box warning violates accepted standards of pharmaceutical company conduct, and should prompt either penalties or the removal of the drug from the market. If Pfizer is going to publicly undermine the required black box warning, then clearly that warning is not adequate to protect consumers and the FDA must either penalize Pfizer so that it desists from this behavior or pull the drug from the market since it is becoming clear that the company is undermining that warning in the eyes of the public.

Actually, it is the behavior of Senator Rockefeller that is what is wrong with this country. And it is Senator Rockefeller who should not be able to sleep at night.

"The FDA proposalwouldsignificantly delay the implementation of premarket review for newly covered products. Most egregiously, the proposal creates a twenty-four month provisional period for the submission of tobacco product marketing applications. Applicationsreceived during the provisional period enable thecontinued marketing of the productuntil the FDA acts on the application which may be wellbeyond the twenty-fourmonth period. A similar loophole was established during the passage of the Act to apply to cigarettes and smokeless products. The FDA received 3,517 applications but three years later has only issued an order removing four products from the market. After the withdrawal of 117 applications, the tobacco companies are still able to market the unapproved products represented by the 3,396 outstanding applications."

At the end of the day, if you need to lie in order to make your point, it seems to me that you need to go back and reassess your position. I think today would be a good day for ANR to go back to the drawing board.

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