Consumer-rights advocates said the internal documents showed that the staff experts at the FDA were overruled by the White House and its political appointees.
"I think they are devastating to the government's case. They show that the nonpolitical people -- the actual experts in the drug-approval process -- didn't agree with the approach of deferring to the companies," said Brian Wolfman, director of the Public Citizen Litigation Group.
Nan Aron, president of the Alliance for Justice, a liberal legal advocacy group, said it was "unconscionable that our leaders would attempt to protect powerful corporations from liability at the expense of the safety of American consumers."
But the FDA's Office of Public Affairs defended its process.
"FDA encourages and expects a robust exchange of ideas on matters of public health and public policy. As in any organization, there is rarely unanimity of opinion," officials said in a statement. "In proposing the rules, FDA carefully considered dissenting viewpoints. Many employees of FDA participated in the development and review of the rules."
Prior to the Bush administration, the FDA had taken the view that lawsuits against drug makers provided extra protection for consumers. Often, these suits revealed information about the risks of a prescription drug that were not well-known or were hidden by the manufacturer.
However, the Bush administration saw lawsuits as costly and ineffective. They argued that federal regulators were in a better position than ordinary jurors to understand the risks and rewards of a drug. For that reason, they argued that once the FDA had given its approval to a new drug, juries should not be permitted to second-guess that decision by finding a drug to be unreasonably dangerous.
The documents obtained by Waxman's staff show that career officials at the FDA did not share the administration's view that consumers are fully warned of the risks of newly approved drugs.
"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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david.savage@latimes.com
