title: FDA preemption of drug and device labeling: who should decide what goes on a drug label?
abstract: The Supreme Court decided an issue that is critical to consumer health and safety last year. In April 2009, the Supreme Court held that extensive FDA regulation of drugs did not preempt a state law claim that an additional warning on the label was necessary to make the drug reasonably safe for use. Thus, states--and even courts and juries--are now free to cast their vote on what a drug label should say. This is in direct contrast to medical devices, where the federal statute regulating medical devices expressly provides that state regulations are preempted. This Article discusses basic preemption principles and drugs, and explores the policy ramifications of pro- and anti-preemption policy in the healthcare industry.
authors.affiliation: Boulware & Valoir, Houston, USA. tvaloir@boulwarevaloir.com
authors.forename: Tamsen
authors.initials: T
authors.lastname: Valoir
authors.forename: Shubha
authors.initials: S
authors.lastname: Ghosh
mesh_terms: D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D006801:Humans; D011356:Product Labeling / Q000331:legislation & jurisprudence*; D035521:Supreme Court Decisions; D014481:United States; D014486:United States Food and Drug Administration