CONGRESSIONAL MOMENTUM BUILDS IN SUPPORT OF GENERIC DRUG APPROVALS UNDER GATT...SAVING AMERICANS MORE THAN $6 BILLION.

WASHINGTON--(BUSINESS WIRE)--April 25, 1995--Senator David Pryor of Arkansas has joined a growing number of Congressional leaders in calling for continued generic drug approvals once the General Agreement on Tariffs and Trade (GATT) treaty is in place.

Senator Pryor sent a copy of the GATT Economic Impact Study to his Senate colleagues, which shows that this treaty could cost the American public over $6 billion in higher drug prices due to windfall brandname drug patent extensions, along with a letter asking his colleagues to support his position of saving Americans this expense. Senator Pryor wrote:

"Under the GATT transitional provisions, lower-cost generic versions would theoretically enter the market in the near future. It has been argued, however, that an obscure provision of drug law prohibits the FDA from approving these generic drugs during the GATT patent extensions, regardless of the investment put forth by the generic manufacturers.

"In no way did the Congress intend GATT to obstruct the free market, hinder FDA product approvals or induce particular industries to seek special treatment through a loophole in the treaty's implementing legislation. If you share my concerns, I ask that you contact FDA Commissioner David Kessler before the agency reaches its decision in the next few weeks. Should it be necessary, I hope you will also join me in seeking a technical amendment which will resolve this issue in the interests of consumers."

Senator Pryor's call-to-action for members of Congress both echoes and reinforces the concerns recently expressed by Representatives Henry Waxman of California and Carrie Meek of Florida. In April 4, 1995 letters to Dr. David Kessler and to Ambassador Mickey Kantor, U.S. Trade Representative, Representative Meek wrote that if generic drug approvals are not continued, "brandname drug companies will receive a 'windfall' of more than $6 billion paid for by the American consumer and the federal and state reimbursement agencies." Representative Henry Waxman of California wrote to Dr. Kessler (March 29, 1995), stating, "It would seem a fair interpretation consistent with the legislative intent simply to continue to recognize pre-GATT patent expiration dates previously certified in pending ANDA's for purposes of FDA approval (of generic drugs) during this transition period."

For further information, please feel free to directly contact Robert S. Milanese, President, NAPM at [phone]. Copies of Senator Pryor's, Congressman Waxman's and Congresswoman Meek's letters are available upon request, as is the GATT Economic Impact study conducted by Stephen W. Schondelmeyer, Pharm.D., Ph.D; Professor and Director of the PRIME Institute at the University of Minnesota.

CONTACT: NAPM

Ruth Weinstein, 516/741-3699