APPROVAL OF NEW DRUGS IN THE UNITED-STATES - COMPARISON WITH THE UNITED-KINGDOM, GERMANY, AND JAPAN

In a study reported herein, the marketing approval dates of 214 drugs newly introduced into the world market from January 1990 through Decem ber 1994 were compared in 4 countries. The analysis reveals that the U nited States and the United Kingdom have similar patterns of drug avai lability, although the United States has a number of therapies with si gnificant public health benefits that are not yet available in the Uni ted Kingdom. The findings also show that the United States outpaces bo th Germany and Japan in approving important new drugs. Various strateg ies adopted by the Food and Drug Administration to expedite its pharma ceutical review process, including the use of industry user fees, are described.