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U.S. pharmaceutical industry to increase research spending.

WALL STREET JOURNAL July 28, 1998.

WASHINGTON -- The U.S. pharmaceutical industry will spend $21 billion this year on research and development, 11 percent more than in 1997.

Pharmaceutical company sales are projected to reach $124.6 billion this year, up 12.4 percent from 1997's $110.8 billion.

According to the 1998 Industry Profile, released by the trade group Pharmaceutical Research and Manufacturers of America, the industry is developing 538 new medicines to fight 12 major conditions: Alzheimer's disease, arthritis, asthma, cancer, congestive heart failure, coronary heart disease, depression, diabetes, hypertensive heart disease, osteoporosis, schizophrenia and stroke.

The report also shows that drug companies are spending more time and money discovering and testing new drugs, and that medicines are tested in more clinical trials and on more people now than ever before.

In the 1981-84 period, each new drug application filed with the U.S. Food and Drug Administration included information from an average of 30 clinical trials, testing the drug on an average of 1,321 people. By 1994-95, the average number of trials had more than doubled, to 68, and the average number of patients more than tripled, 4,237.

Meanwhile, though, FDA's drug approval process has grown faster: Between 1987 and 1997, the mean time between the submission of a new drug application and its approval was cut in half, to 16.2 months from 32.4 months. A subject of particular urgency in that time has been the search for AIDS treatments: In 1987 there was one drug approved to treat the disease, and 27 more were in clinical trials. Last year, there were 50 approved anti-AIDS drugs, with 124 more in clinical trials.

But while approval time has been reduced, drug development time has increased. By 1996, the development time was about 15 years, nearly double the eight-year average of the 1960s.

The United States is the long-term leader in launching drugs used globally --between 1975 and 1994, 45 percent of them originated here. Britain was second with 14 percent, and Switzerland third with 9 percent.

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