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.
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.