A U.S. lawmaker is pushing the Food and Drug Administration to provide more guidance on listing patents for drug-and-device combination products, such as asthma inhalers and auto-injectors for diabetes treatments, in a highly important agency registry known as the Orange Book.
In a letter dated Monday, Sen. Bill Cassidy (R-La.) accused the FDA of failing to take responsibility for an issue that has long vexed a growing number of people over the implications for the availability of lower-cost generics. The reason is that the registry holds a key, behind-the-scenes role in shaping the competitive landscape of the pharmaceutical industry.
The patents listed in the Orange Book are cited by brand-name drugmakers to put their generic rivals on notice about certain types of patents that are claimed for a medicine. The stipulation is mandated in the Hatch-Waxman Act, a federal law used to sort out patent infringement cases that can delay the arrival of generics in medicine cabinets.
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