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FDA’s Drug Label Rule Fails to Guarantee Access to Vital Information and Includes ‘Sneak Attack’ on Patients’ Legal Rights

Jan. 18, 2006

FDA’s Drug Label Rule Fails to Guarantee Access to Vital Information and Includes ‘Sneak Attack’ on Patients’ Legal Rights

Bush Administration Abuses Executive Powers in Attempt to Override  State Liability Laws

WASHINGTON, D.C. – The U.S. Food and Drug Administration, though it has improved a drug labeling regulation through revisions announced today, continues to ignore the fact that its rule will not guarantee patients the most accurate, up-to-date information about their medications, Public Citizen said today.

Further, in an end-run around Congress, the FDA has added to the rule a preamble designed to preempt lawsuits filed by patients under state law, potentially leaving victims of FDA-approved drugs with no remedy for any harm caused by the approved drug.

Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said revisions in the final version of the rule released today will simplify and prioritize the labeling information that doctors receive. But the vast majority of patients will not get that information unless they specifically request it. Instead, they commonly receive patient information leaflets (PILs) that are commercially produced but whose content is not scrutinized by the FDA.

The FDA’s own study has shown that the content of unregulated leaflets gets a failing grade (average 50 out of 100) in conveying the most important information to patients, Wolfe said. The agency has the authority to require agency-approved “medication guides” for each new prescription and refill but has done so for only about 75 drugs.

“It is time to end the double standard where doctors and other health professionals are informed by FDA-approved labeling, but patients are treated like second-class citizens, receiving whatever the out-of-control purveyors of patient information leaflets choose to dispense,” Wolfe said. “This is a dangerous situation, made worse by the FDA’s poor record of approving harmful drugs based on limited, and even fraudulent, clinical trials performed by the drug companies.”

In a further blow to consumers, the final rule now contains a preamble aimed at preempting the rights of patients to sue drug manufacturers if a drug is approved by the FDA. The Bush administration has previously failed to persuade Congress and, with a few exceptions, the courts (where it has filed amicus briefs) to shield drug makers from liability. The new tactic of writing preemption language into federal regulation notices is an attempt to bypass Congress and override consumer protection liability laws, said Public Citizen President Joan Claybrook. The administration has also used such language in recently proposed automobile safety rules.

“This is a sneak attack on consumer rights,” Claybrook said. “President Bush is once again abusing his executive powers, this time in his attempt to protect the big pharmaceutical companies from the consequences of their actions. Thousands of people in this country have died or been seriously injured by drugs approved by the FDA, and this administration is saying it doesn’t think people should have any recourse.”

It remains unclear what impact the language will have on liability cases.

“Ultimately, we are confident that the courts will not defer to the FDA’s opinion on preemption, which is not based on any authority given to the FDA by Congress,” said Brian Wolfman, director of the Public Citizen Litigation Group and an expert on preemption law. “In the meantime, however, the drug companies will be emboldened by this preemption statement, and use it to complicate injury cases and deter victims from seeking justice in the courts.”

Drug labeling has been a problem for decades.

In 1981, the Reagan administration cancelled a proposed regulation requiring FDA-approved leaflets to be dispensed with prescriptions just before the rule was to go into effect. The abrupt reversal came at the behest of drug companies, pharmacy organizations and some physician groups. Private sector-designed leaflets, not approved by the FDA, thereby continued to be the norm.

Several years ago, shortly after Dr. Mark B. McClellan became FDA commissioner, he listed as one of his top five priorities helping consumers obtain truthful information about products they use so they can make informed decisions. The FDA could go a long way toward achieving this priority by immediately moving forward with a long-overdue initiative to require the mandatory distribution of FDA-approved written drug information with each new and refill prescription, Wolfe said.

In a study conducted several years ago by the University of Wisconsin for the FDA, although 89 percent of consumers were receiving some sort of information(unregulated PILs) when a prescription was filled, none of the approximately 1,300 leaflets studied for four common drugs achieved minimum goals for useful, scientifically accurate drug information. As measured by eight objective criteria, the overall usefulness of information was about 50 percent. According to the authors, “a majority of leaflets did not include adequate information about contraindications, precautions, and how to avoid harm.”

“The notion that consumer drug information can be 50 percent useful is unfathomable,” Wolfe said. “Drug information that communicates only half of what it should is misleading, and misleading drug information is potentially dangerous.”