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December 11, 1996

Approval of New Drugs in the United StatesComparison With the United Kingdom, Germany, and Japan

Author Affiliations

From the Office of the Commissioner (Dr Kessler and Ms Feiden), Office of Planning and Evaluation (Mr Hass), and Center for Drug Evaluation and Research (Drs Lumpkin and Temple), Food and Drug Administration, Rockville, Md. Dr Kessler is the commissioner of the Food and Drug Administration.

JAMA. 1996;276(22):1826-1831. doi:10.1001/jama.1996.03540220050030

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.