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Complete Preemption Opposed by FDA Officials

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From the Associated Press’ Kevin Freking:

Top scientists and career employees at the Food and Drug Administration opposed agency regulations that weaken consumers’ ability to sue drug makers, congressional investigators said Wednesday.

At issue is language in a drug-labeling rule from 2006 that effectively limits when people can sue in state court over injury claims involving medications. The FDA contends federal regulations prevail when there is a conflict with state law. This concept is called pre-emption.

Internal agency documents showed that career officials opposed this approach, according to a report released by Rep. Henry Waxman, chairman of the House Oversight and Government Reform Committee. In the past, the agency had viewed private suits as an additional layer of protection against unsafe drugs, the report said.

"Much of the argument for why we are proposing to invoke pre-emption 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," the report quoted Dr. John Jenkins, who oversees FDA’s new drug reviews, as saying. "We know that such an assumption is false."

Patients injured by drugs have won suits against drug manufacturers for failing to warn against certain dangers.

FDA officials said the agency encourages robust debate on public policy, so some dissension can be expected.

In the end, the agency determined that finalizing the rules were the appropriate action.

"It was appropriate because FDA is the public health agency charged by Congress with the responsibility to ensure that drugs and certain medical devices are safe and effective and that the labeling adequately informs users of the risks and benefits of the product," Chappelle said. "In addition, the agency is uniquely qualified to make such important and complex judgments."

Public Citizen, the consumer advocacy group, said the Bush administration had pushed pre-emption clauses in a wide array of regulations.

"This effort to prevent injured citizens from using the courts and holding negligent companies’ accountable must be stopped," said Brian Wolfman, director of Public Citizen’s litigation group.

The report said the FDA has yet to provide a complete set of documents that would show communications between the White House and the agency, but some documents suggested the agency and the White House would not go forward with a rule on labeling until the pre-emption changes were included.