Recent legislative developments include amendments to expand upon Orange Book and Purple Book listing requirements.
Amidst the breathtaking sweep of activities in the Trump Administration’s waning days in office, the Orange Book Transparency Act of 2020 (the “Orange Book Act”) and the so-called Purple Book Continuing Act (the “Purple Book Act”) were both signed into law with relatively little public fanfare. Both of these bills largely codify in statute the patent-listing and related requirements currently incorporated in FDA’s regulations and guidance. Nevertheless, the recent codification provides additional regulatory clarification and certainty, and, more notably, includes additional substantive requirements. Each of these Acts is summarized below.