FTC Sees Red Over Alleged Misuse of FDA Orange Book, Puts 10 Pharmas on Notice

MedCity News November 7, 2023
Frank Vinluan

The Federal Trade Commission says more than 100 patents from 10 biopharma companies are improperly listed in the FDA’s official publication of approved products. Such listings delay generic competition, which reduces consumer choice and keeps prices high, the regulator said.

AbbVie, AstraZeneca, and GSK are among the 10 companies now under scrutiny by the Federal Trade Commission, which is cracking down on businesses it says improperly or inaccurately placed items on a list of FDA-approved products as a way to hold off generic competition.

The commission on Tuesday said it is challenging more than 100 patents in this “Orange Book,” disputing the accuracy or relevance of the listed patent information. The challenge means that product manufacturers might have to remove...

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