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Thursday, January 19, 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.
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