Supreme Court justices on Wednesday heard oral arguments over a drug approval pathway that could have implications for the availability of cheaper generic medicines.
The case, Hikma v. Amarin, centers on “skinny labeling,” a process that allows generic drugs to come to market faster. Under the skinny labeling pathway, the Food and Drug Administration allows generic drugs to enter the market for unpatented uses. It allows consumers to have quicker access to cheaper options.
The legal battle involves Amarin, which made a fish-oil drug, Vascepa, for people at high risk of heart disease, and Hikma, a company that gained approval for a generic version of the drug.
Amarin sued, arguing that Hikma’s marketing material for its generic drug encouraged doctors to prescribe it for Vascepa’s patented use.
Hikma’s marketing materials referred to its product as the “generic version” of Vascepa without noting that the product was not intended for all the approved uses of Vascepa.
The lawsuit was dismissed in 2022, but in 2024, the U.S. Court of Appeals for the Federal Circuit revived the case and ruled in favor of Amarin. Hikma appealed to the Supreme Court. It wasn’t clear Wednesday which way the justices would rule, and a decision is expected by July.
A ruling in favor of Amarin could increase the legal risk that comes with skinny labeling, potentially chilling the market and resulting in fewer generic drugs coming to consumers. Fewer generic drugs coming to market would mean higher prices for patients.
Some, however, say the skinny labeling pathway is so lucrative that the Supreme Court’s potential decision might not have a large chilling effect.
“Even if [a generic drugmaker] gets sued, it’s better to get sued and get approval than to not get approval,” University of Illinois law professor Jake Sherkow told NPR. “So I don’t think anyone’s going to stop using skinny labels.”
More than 70 scholars weighed in on the case in support of Hikma, warning that the Delaware appeals court’s decisions discourage the use of skinny labeling, which they called an “essential pathway.”
“Skinny labeling has resulted in proven benefits for access to medicines and competitive drug pricing,” they wrote.