FTC Again Polices FDA ' s Laziness With Improper Orange Book Listings for Diabetes, Weight Loss, Asthma and COPD Drugs

Today (April 30, 2024), the U.S. Federal Trade Commission (FTC) announced that it had expanded its campaign against pharmaceutical manufacturers ’ improper or inaccurate listing of patents in the Food and Drug Administration ' s (FDA) Orange Book (see the news release athttps://www.ftc.gov/news-events/news/press-releases/2024/04/ftc-expands-patent-listing-challenges-targeting-more-300-junk-listings-diabetes-weight-loss-asthma for more information). FTC is targeting what it describes as more than 300 " junk " patent listings because the particular patents are legally ineligible to even be listed in the FDA Orange Book.Listing patents in the Orange Book can, if listings are improper (as defined by law) adversely impact competition. Because the FDA Orange Book is populated by the pharmaceutical industry, and the FDA really has little supervision of the listings contained in the Orange Book unless there is a drug recall, it is essentially self-enforced. Which leaves the listings open to the type of abuse FTC is now challenging.FDA entrusts branded drug manufacturers to be responsible for ensuring their patents are properly listed. Yet certain manufacturers have improperly submitted patents for listing in the Orange Book which claim neither the reference listed drug, nor a method of using it. Unfortunately, several companies focused on diabetes products were included among the 300 listings which appear to be improperly listed in the FDA Orange Book patents anyway.For example, th...
Source: Scott's Web Log - Category: Endocrinology Tags: 2024 FDA FTC improper listings Orange Book pharma Source Type: blogs