FTC Amicus Brief Challenges Abuse of FDA “Orange Book” Listing Procedures to Block Drug Competition

The FDAs Orange Book is a list of drugs that are approved by the agency as safe and effective.

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Provider: 
FTCFTC
URL: 
https://www.ftc.gov/news-events/news/press-releases/2022/11/ftc-amicus-brief-challenges-abuse-fda-orange-book-listing-procedures-block-drug-competitionhttps://www.ftc.gov/news-events/news/press-releases/2022/11/ftc-amicus-brief-challenges-abuse-fda-orange-book-listing-procedures-block-drug-competition
Retrieved on: 
Friday, November 11, 2022
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Tags: 
Risk Evaluation and Mitigation Strategies, Patent, Approved Drug Products with Therapeutic Equivalence Evaluations, Food, FTC, Commission, Jazz, News, District, Federal Trade Commission, REMS, Douglas v. U.S. District Court ex rel Talk America, Lesbian flag, Program, Blog, District court, Social media, History, Orange Book, FDA, Pharmaceutical industry, Avadel Pharmaceuticals
Geotags: 
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Summary
Key Points: 
  • The FDAs Orange Book is a list of drugs that are approved by the agency as safe and effective.
  • The FTCs 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.
  • After listing it in the Orange Book, Jazz filed a patent infringement lawsuit against Avadel, triggering a 30-month stay and blocking final FDA approval of Avadels competing narcolepsy drug.
  • The FTC amicus brief takes no position on the scope or claim construction of the 963 patent but argues generally that REMS distribution patents are not properly listed in the Orange Book.
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