WASHINGTON — 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 regulators said the White House and top administration officials were operating under the "false assumption" that warning labels on new drugs were adequate and up-to-date. Instead, they said, new information often comes to light that calls for new warnings to doctors and patients.
The documents are from 2003, when there was an internal debate within the Bush administration over whether to drop the Food and Drug Administration's long-standing policy allowing lawsuits in state courts as well as federal regulations.
Contrary to the view of the White House and the FDA general counsel, the drug regulators said pharmaceutical manufacturers could not be trusted to warn patients of new risks. "Our experience hasn't shown this. Companies rarely press for meaningful risk information or additional warnings," said a memo from Dr. John Jenkins, director of the Office of New Drugs, and Jane Axelrad, associate director for drug policy at the FDA's Center for Drug Evaluation and Research.
The documents shed new light on a major controversy that comes before the Supreme Court on Monday. At issue is whether the federal approval of a prescription drug bars an injured patient from suing the drug maker.
For more than a century, the federal government has regulated new drugs. At the same time, people hurt by drugs could sue the drug maker before a jury and try to prove they were not warned of the risks posed by the drug.
In the case before the court, Diana Levine, a Vermont musician, lost her arm to amputation after she was injected with an anti-nausea drug made by Wyeth. The warning label told doctors and nurses to use extreme caution before injecting the drug, Phenergan. If the needle struck an artery, it could cause gangrene.
The warning label did not say Phenergan should not be injected because of the danger. Levine sued Wyeth and alleged the warning label was inadequate, and a jury awarded her $6.7 million in damages.
But the Bush administration has joined the case on the side of Wyeth and urged the high court to rule that the FDA's approval of the drug and its warning labels bars or "preempts" lawsuits against the drug maker.
