Approval of new drugs in the United States. Comparison with the United Kingdom, Germany, and Japan
D. A. Kessler, A. E. Hass, K. L. Feiden, M. Lumpkin and R. Temple
Office of the Commissioner, Food and Drug Administration, Rockville, MD 20857, USA.
In a study reported herein, the marketing approval dates of 214 drugs newly
introduced into the world market from January 1990 through December 1994
were compared in 4 countries. The analysis reveals that the United States
and the United Kingdom have similar patterns of drug availability, although
the United States has a number of therapies with significant public health
benefits that are not yet available in the United Kingdom. The findings
also show that the United States outpaces both Germany and Japan in
approving important new drugs. Various strategies adopted by the Food and
Drug Administration to expedite its pharmaceutical review process,
including the use of industry user fees, are described.
