FDA criticized for failing to provide clarity on drug-and-device patents

When it comes to a crucial controversy over pharmaceutical patents, the FDA has been MIA.

For nearly 20 years, drug companies have asked the Food and Drug Administration for guidance on listing patents for drug-and-device combination products, such as asthma inhalers and auto-injectors for diabetes treatments, in an obscure, but highly important agency registry. Known as the Orange Book, it holds a key, behind-the-scenes role in shaping the competitive landscape of the pharmaceutical industry.

Here’s why: The patents listed in the registry are cited by brand-name drugmakers to put their generic rivals on notice about certain types of patents that are claimed for a medicine. This is no mere administrative matter. 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 lower-cost generics in medicine cabinets.

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