In a surprising move, a federal appeals court panel may revisit a controversial decision that has raised concerns about the ability of generic drug makers to supply Americans with lower-cost alternatives to pricey brand-name medicines.
At issue is an odd term with important implications: skinny labeling. The phrase refers to an effort by a generic company to seek regulatory approval to market its medicine for a specific use, but not other patented uses for which a brand-name drug is prescribed. For instance, a generic drug could be marketed to treat one type of heart problem, but not another. By doing so, the generic company seeks to avoid lawsuits claiming patent infringement.