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.
This tactic has been a linchpin among generic companies ever since a federal law known as the Hatch-Waxman Act went into effect more than three decades ago. The law established the mechanisms by which generic drugs can more readily enter the marketplace. And skinny labeling, which amounts to a carve-out, was one way that Congress attempted to foster more competition to benefit consumers.
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Was the ‘good’ created by the FDA requirement that the generic drug label be changed overcome the ‘bad’ created by this lawsuit by forcing people to pay more for the same thing? If the answer is ‘no’ then the outcome is an embarrassment to our system and the American people. If the answer is ‘yes’ the label is the greater good, this law has to be changed because it hurts consumers. Then again, we have PBMs to protect us.