"Amendments to Labeling: Implications for Preemption Defense," Health Lawyers Weekly, AHLA, January 25, 2008 by Joseph P. McMenamin and Deborah M. Russell, McGuireWoods LLP
In what is sure to be seen as more ammunition for the battle over the preemption defense, the Food and Drug Administration (FDA) proposes rulemaking to codify its longstanding view that changes to labeling for approved products (i.e. drugs, biological products, and medical devices) may be made before agency review only as a narrow exception to the requirement of FDA approval and under limited circumstances. In its proposed rule announced last week, a supplemental application to change labeling may be used to add or strengthen a contraindication, warning, precaution, or adverse reaction in advance of the agency’s review of such change, but only based on newly acquired and novel safety information and only if there is sufficient evidence of a causal association with the drug, biologic, or device. The agency wishes to formalize this “narrow exception” position. See 73 Fed. Reg. 2848 (Jan. 16, 2008).
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