Roanoke Times
Copyright (c) 1995, Landmark Communications, Inc.
DATE: FRIDAY, May 26, 1995 TAG: 9505260089
SECTION: NATIONAL/INTERNATIONAL PAGE: A10 EDITION: METRO
SOURCE: ASSOCIATED PRESS
DATELINE: WASHINGTON LENGTH: Medium
The agency said it was forced to make that decision because of a new global trade agreement and the way that Congress chose to implement it.
The lawmakers may have been unaware of how the implementing legislation for the General Agreement on Tariffs and Trade would affect competition in the prescription drug market.
GATT extends patent protection to 20 years for a wide range of products. Drugs in the United States have had a 17-year patent from the time they were approved. Effective June 8, the patents will extend to 20 years from the date the manufacturers filed for a patent.
``Our legal analysis was that the generic companies have to wait until the extended patent expires before they may market their products,'' said William B. Schultz, the deputy FDA commissioner who handed the victory to drug giant Glaxo Wellcome Inc.
Glaxo's Zantac, the ulcer remedy that was due to lose its patent protection in December, will be able to keep its monopoly until July 1997 under the agency's ruling. One of the top selling medicines in the world, Zantac costs $83 for a month's supply, the company says.
Generic makers had hoped to bring copies onto the market at year's end at half that price.
Sen. David Pryor, D-Ark., who had tried to dissuade the FDA from the position it took Thursday, warned that it would cost consumers billions of dollars in higher prices for years. He said he would try to rush through legislation to override the FDA.
``It means that there's going to be unjust enrichment for several drug companies. This is a classic case of unintended consequences,'' said Pryor, who has long crusaded against high drug prices. ``This was never intended by Congress, it was never intended by anyone negotiating GATT. It was an error, and it should have been corrected by FDA.''
``GATT's whole intention was to help consumers. This goes just the other way,'' Pryor said.
Lewis A. Engman, president of Generic Pharmaceutical Industry Association, called the FDA decision ``outrageous.''
``Today FDA chose to give big drug companies windfall profits, which will be paid for by American consumers,' Engman' said. ``I am surprised that this administration would force consumers to pay dramatically higher prices for drugs.''
But Nancy Pekarek, manager of media relations for Glaxo, said it will help consumers by giving the pharmaceutical companies that develop new drugs a bigger incentive to discover new medicines.
by CNB