On the recordOctober 11, 2000
the judge said that they hold that the Hatch-Waxman amendments that already exist to the Food, Drug and Cosmetic Act require the labeling be used, be given by the drug manufacturer to the generic which means then, or to the reimporter in our particular case, and that it is not an infringement of copyright liability and, therefore, the drug company will have to provide the labeling under the discretion of the FDA. The FDA has broad discretion in this area and, therefore, all of that is covered in the language that exists in the bill that we are about to vote to pass.
Source
govinfo.gov
