Senator Pryor has offered an amendment, of which I am a cosponsor, that would correct an unintended loophole created in the legislation implementing the General Agreement on Tariffs and Trade [GATT]. It is estimated that the loophole will ultimately result in a windfall profit of approximately $2.5 billion to certain drug companies. Congress must take the responsible course of action and correct its mistake by passing the Pryor amendment. Time is running out to correct this matter. Each day of inaction results in increased costs to consumers. In addition, to those who argue that this is not the appropriate vehicle, this amendment will result in savings to the Department of Defense [DOD] via the cost of prescription drugs purchased through DOD health programs. How did this loophole come about? When Congress enacted the Uruguay Round Agreements Act [URAA], the legislation implementing GATT, which I opposed, it extended all patent terms from 17 years from date of approval to 20 years from the filing date. In addition, the legislation allowed generic companies to market their products as of the 17-year expiration date if they had made a substantial investment and would pay a royalty to the patent holder. The carefully constructed transition rules were meant to apply to all industries. However, because conforming language to the Federal Food, Drug, and Cosmetic Act was inadvertently omitted, this provision does not apply to the generic pharmaceutical industry.
Cord Byrd: “Senator Pryor has offered an amendment, of which I am a cosponsor, that would correct an unintended loophole created in…”
On the recordJune 27, 1996
Source
govinfo.govEditor's note · Context
Discussing an amendment to correct a loophole in GATT legislation affecting drug companies.
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