US Block On Generics "Costing $5 Million A day"

The delay in the availability of generic drugs caused by the US Congressional oversight in implementing legislation for the General Agreement on Tariffs and Trade is costing US consumers $5 million a day, and without correction the loss will eventually reach $2.5 billion, says James Firman, president of the National Council on Aging.

Addressing a hearing of the Senate Judiciary Committee, Dr Firman said the loss to that date (February 27) resulting from the oversight had been $330 million. While this could not be recovered, correcting the GATT oversight could save consumers and taxpayers an average of $5 million every day to the end of the century. "The Medicaid savings alone would pay for basic health care services for more than 188,000 children," said Dr Firman, who is also chairman of the Generic Drug Equity Coalition.

In what the Coalition says may be the largest inadvertent corporate windfall in US congressional history, brand-name prescription drugmakers have benefitted from an oversight in the drafting of US GATT implementing legislation. the practical effect of the treaty was to extend patent protection from 17 to 20 years, but Congress drafted legislation that would not penalize generics makers which had already made a significant investment in a new product, in anticipation of the expiry of a 17-year patent. However, legislators forgot to apply the "transition" conditions to a clause in the Food, Drug and Cosmetic Act, which bars generics from the market before the patent expires. Subsequently, US trade representative Mickey Kantor wrote to members of Congress that: "conforming amendments should have been made....but were overlooked."