STAT May 13, 2024
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...