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Pallone Applauds FTC Action to Reduce Drug Prices by Combating Improper Pharmaceutical Patent Listing

June 5, 2024

FTC Recently Challenged More Than 300 Improper or Inaccurate Orange Book Listings for Diabetes, Weight Loss, Asthma and COPD Drugs

Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ) released the following statement in support of the Federal Trade Commission’s (FTC) ongoing action to challenge improperly or inaccurately listed pharmaceutical patents, which can be used as a tool to delay more affordable generic competition from coming to market:  

“I commend Chair Khan and the entire Commission for their commitment to standing up against unfair industry practices that prevent more affordable generic alternatives from coming to market sooner. We’ve long known that pharmaceutical companies take advantage of the Orange Book to block competition, and that’s why Congress passed bipartisan legislation to bring much-needed transparency to the patent listing process. I strongly support the FTC’s work to challenge junk patent listings, which are nothing more than an illegal tactic to allow greedy corporations to continue to price gouge Americans for lifesaving medications. I will be closely following the responses of these 10 pharmaceutical companies and the FTC’s continuing work to protect Americans from industry abuse of the Orange Book protections.”

The FTC recently sent warning letters to 10 companies and notified the Food and Drug Administration (FDA) that it disputes the accuracy or relevance of more than 300 Orange Book patent listings across 20 different brand name products. These patent listings are currently listed in the FDA’s publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the Orange Book, which lists drug products approved by the FDA as safe and effective. 

The latest warning letters were sent to:

  • AstraZeneca and Novo Nordisk for obesity and type-2 diabetes injectable drugs;
  • Boehringer Ingelheim, Covis Pharma, Glaxo-Smith Kline, Novartis Pharmaceuticals Corp., Teva Pharmaceutical Industries Ltd. and their subsidiaries for asthma and COPD inhalers; and
  • Amphastar Pharmaceuticals Inc. for a glucagon nasal spray to treat severe hypoglycemia in type-1 diabetics.   

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Issues:Health