In a recent announcement, the U.S. Federal Trade Commission (FTC) declared its issuance of notice letters to several prominent drugmakers and medical device companies, including Abbvie, AstraZeneca, and Teva. The letters addressed concerns regarding the accuracy and relevance of over 100 patents listed in the U.S. Food and Drug Administration’s Orange Book.
A significant portion of the patents in question were related to medical devices such as asthma inhalers and epinephrine autoinjectors, according to the FTC.
FTC Chair Lina Khan expressed her apprehensions about wrongfully listed Orange Book patents, emphasizing their potential to inflate drug prices, hinder fair competition, and impede the development of superior medications. In a statement shared on the platform X, formerly known as Twitter, Khan highlighted the adverse impact of listed patents on the accessibility and affordability of essential medical devices.
She remarked, “Millions of Americans depend on inhalers to manage their asthma. Despite being available for decades, some of the most popular inhalers continue to impose high costs on patients, amounting to hundreds of dollars per month.”
The Orange Book serves as a repository for FDA-approved drugs and products, but the FTC has raised concerns about the dubious listing of patents that could potentially obstruct the entry of more affordable generic alternatives, delaying healthy competition.
Notably, the FTC had issued a warning in September, cautioning drugmakers against the improper listing of patents with federal health regulators and indicating its intent to scrutinize any such misrepresentations, with the possibility of legal consequences.
(Reporting by Diane Bartz and Patrick Wingrove; Editing by Bill Berkrot)
