Senator urges FDA to clarify drug patent listing in ‘Orange Book’

U.S. lawmakers are asking the Food and Drug Administration to do more to list patents for drug-device combinations, such as asthma inhalers and auto-injectors for diabetes treatment, in the all-important registry known as the Orange Book. We are asking you to provide guidance.

In a letter dated Monday, U.S. Sen. Bill Cassidy (R-Louisiana) wants the FDA to take responsibility for issues that have long plagued many people over the impact on the availability of low-cost generic drugs. He accused them of not taking it. That’s because registries play an important behind-the-scenes role in shaping the competitive landscape of the pharmaceutical industry.

Patents listed in the Orange Book are cited by brand-name drug companies to inform generic drug rivals about the specific types of patents asserted for a drug. The provision is required by the Hatch-Waxman Act, a federal law used to sort out patent infringement cases that could delay the arrival of generic drugs on drug shelves.