According to consumer watchdog Public Citizen, the FDA’s new Drug Label Rule Fails to Guarantee Access to Vital Information and Includes ‘Sneak Attack’ on Patients’ Legal Rights.
Following is an excerpt from a recent Public Citizen’s article:
“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.
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