Oct. 29 (Bloomberg) -- Political appointees at the Food and Drug Administration adopted rules that help shield drugmakers from patients' lawsuits over opposition from the agency's staff, a House report says

Appointees of President George W. Bush supported the changes in 2006 and this year, according to a report today by Democrats on the House Committee on Oversight and Government Reform. The panel is headed by Representative Henry Waxman, a California Democrat, who opposed the rule changes.

The Supreme Court next week will consider whether FDA approval of a drug under the rules provides a legal shield for pharmaceutical companies, barring patient lawsuits that claim a medicine should have carried a stronger warning about potential dangers. The justices are reviewing a $7 million award to a musician whose arm had to be amputated after she was treated with a Wyeth anti-nausea drug.

``FDA has an obligation to ensure the safety and effectiveness of drugs,'' the report said. ``In this case, however, the internal documents indicate that the Bush Administration weakened important drug safety regulations to shield manufacturers from liability. This is a serious abuse of the agency's public health authorities.''

The FDA, in a statement released by the Office of Public Affairs, said the rules were the product of a ``robust exchange'' of opinions inside the agency as it carried out its mandate to protect the public health.

`Rarely Unanimity'

``As in any organization, there is rarely unanimity of opinion,'' the agency said in its statement. ``In proposing the rules, FDA carefully considered dissenting viewpoints. Many employees of FDA participated in the development and review of the rules.''

The 2006 rule took the position that federal drug law bars many patient lawsuits over approved drugs. The agency buttressed that stance this year by limiting the changes companies can make to product warnings without FDA agreement.

Political appointees in the agency's Office of the Chief Counsel pressed for the 2006 rule, and the same office was involved with this year's change, the report found.

Pharmaceutical companies want uniform national safety rules and a shield from billions of dollars in patient claims. A victory for drugmakers in the Supreme Court case would leave at least some injured patients without compensation even if they can show a pharmaceutical company gave short shrift to patient safety.

State Law Pre-emption

The preambles to the FDA rules say that without ``pre- emption'' of state laws, manufacturers would add unneeded warnings to avoid state liability.

The report cited internal e-mails from agency officials who commented on draft copies of the rules.

``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,'' wrote John Jenkins, head of the agency's Office of New Drugs, in advance of the 2006 rule, according to the report.

Jane Axelrad, associate director for policy in the FDA's drug division, wrote in an e-mail to political appointees that drugmakers rarely ``want to disclose more risk information than we think necessary. To the contrary, we usually find ourselves dealing with situations where sponsors want to minimize the risk information.''

In advance of this year's change, Axelrad wrote that the rule ``is not, as it purports to be, consistent with the agency's role in protecting the public health.''

At least one document suggests that the White House ``played a significant role'' in the 2006 rule, the report found.

``A senior career official wrote in 2006 that the FDA Chief Counsel `stated unequivocally that without the language the rule will not go forward (this is per the White House),''' according to the report. ``Other documents reveal that after the changes went into effect, they delayed by months the addition of important safety information on drug labels.''

To contact the reporters on this story: Justin Blum in Washington at jblum4@bloomberg.net; Greg Stohr in Washington at gstohr@bloomberg.net.

Last Updated: October 29, 2008 19:33 EDT