Sunday, November 2, 2008

FDA staff, White House disagreed on drug lawsuits, papers show

The top staff regulators who oversaw the approval of new drugs in this country objected to the Bush administration's drive to shield drug makers from being sued, according to internal documents released Wednesday by Rep. Henry A. Waxman (D-Beverly Hills), chairman of the House Oversight and Government Reform Committee.

"The premise of the basis for much of the argument for why we are proposing to invoke preemption seems to be based on a false assumption that the FDA-approved labeling is fully accurate and up-to-date in a real-time basis," Jenkins wrote in 2003. "We know that such an assumption is false." He added: "It is a gross overstatement of the reality" to say that the drug makers were eager to disclose all of the risks of a new drug.

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