Published on the Packaging World Web site
| August 23, 2005
New FDA label ruling preempts state claims...
New prescription drug labeling rule from the Food and Drug Administration says that if a label meets the agency's requirements, state law failure-to-warn suits over the drug's risks are pre-empted, but plaintiffs' lawyers have vowed to fight.
The rule is intended to make package inserts in prescription drugs easier to read and understand. The rule creates new highlights and table of contents sections to make clearer the major benefits and risks of a drug. The label must also include the date the product was approved by the FDA, in addition to contact information to encourage the reporting of adverse events and side effects. This ruling seen by some as the Bush administration helping Merck with Vioxx litigation.
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