Fixing The FDA's Orange Book

Health Aff (Millwood). 2022 Jun;41(6):797-800. doi: 10.1377/hlthaff.2022.00369. Epub 2022 May 17.


The modern regime for balancing innovation and competition in pharmaceuticals was established through the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act. This regime needs updating. The process that Hatch-Waxman established for listing patents and challenging patents on the Food and Drug Administration's Orange Book is one important area for reform.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Books
  • Citrus sinensis*
  • Drug Industry
  • Drugs, Generic
  • Humans
  • United States
  • United States Food and Drug Administration


  • Drugs, Generic