Federal Trade Commission (FTC) Amicus Brief Challenges Abuse of FDA “Orange Book” Listing Procedures to Block Drug Competition

Excerpt:  “The Brief highlights the significant harm to consumers when a brand company improperly lists a patent on a distribution system in the Food and Drug Administration’s ‘Orange Book’ of approved drugs and thereby blocks the introduction of lower-cost generic medications or other follow-on competition. The FDA’s Orange Book is a list of drugs that are approved by the agency as safe and effective. When a brand pharmaceutical company lists a drug patent in the book it automatically triggers a legal stay that blocks the introduction of competing versions for up to 30 months. The FTC’s amicus brief explains how the Orange Book listing process can be abused and emphasizes the harm to competition and consumers that can result from that abuse, including depriving consumers of potential competition from lower-cost alternatives and the ability to choose between products.”