Dan Coats: “this is an enormously complicated issue with very board implications. I understand that the Judiciary Committee has held…”

“this is an enormously complicated issue with very board implications. I understand that the Judiciary Committee has held hearings on the issue and that as a result, voted 10 to 7 to report out a bipartisan compromise. The compromise reached would allow the FDA to approve a generic drug for marketing prior to expiration of the GATT patent extension, but only after a generic drug manufacturer demonstrated in court that they had made a substantial investment before June 8, 1995. This requirement is contained in both the GATT implementing law and the generic drug approval process in the 1984 Hatch-Waxman law and applies to all generic manufacturers. The investment of a generic drug manufacturer would have to be more than merely the filing of an abbreviated new drug application [ANDA] for regulatory approval with the FDA, although the costs of an ANDA could be included. There have been a lot of questions raised concerning how this transition would work and why, for example, certain industries have been singled out and required to meet special criteria before they can bring their product to the market. In reality, under both current law and the Judiciary Committee compromise, a generic company in any industry must go to court to prove substantial investment, in order to bring its product to market. There is a prevalent misconception that no other industry has to go to court to prove substantial investment. This is simply not true.…”