Memos show FDAers fought preemption

Is Rep. Henry Waxman looking to preempt preemption? Just as the U.S. Supreme Court prepares to hear the big pharma preemption case--Wyeth v. Levine--next week, the Congressman released internal memos that show FDA officials fighting the Bush Administration's move to make the agency's stand on drugs legally unassailable.

As you know, FDA brass and the Bush Administration have been advancing a new doctrine: that agency approval ought to shield drugmakers from legal challenges in state court. But longtime agency officials opposed that view in the memos Waxman released. They said that it's wrong to assume FDA-approved drug labels are always up-to-date, reliable, and based on a drugmaker's full disclosure of safety risks.

"[M]uch 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," wrote John Jenkins, a top official in the drug approval section, according to the Wall Street Journal. And Jane Axelrad, FDA's associate director of CDER at the time, wrote that, "we usually find ourselves dealing with situations where sponsors want to minimize the risk information." According to Axelrad, preemption wouldn't be "consistent with the agency's role in protecting the public health."

The memos appear to be fuel for a Congressional bid to reverse Bush's anti-lawsuit policy, which has extended not only to the FDA and drugmakers, but through other regulatory agencies as well. So no matter what the Supremes decide on the Wyeth v. Levine case, the preemption argument won't be over.

- read the WSJ story

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