U.S. regulators approved dozens of inhalers to treat asthma and chronic obstructive pulmonary disease over a recent 15-year period, but a new study found that generic companies have only twice successfully pursued an established pathway to create lower-cost, rival products.
The paltry outcome was largely blamed on steps that brand-name manufacturers take to forestall would-be competitors, as well as the high bar for regulatory approval. As a result, the study authors argued that a decades-old law designed to encourage generic drug development has failed to foster sufficient competition for inhalers and that reforms are needed to create lower-cost options.
Specifically, the Food and Drug Administration endorsed 53 brand-name inhalers between 1986 and 2020. During that time, generic companies attempted to challenge just seven brand-name patents under the provisions of a law known as the Hatch-Waxman Act, which was created to speed generic products to market but relies on a complicated process to do so.
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