Drug prices' link to development time questioned

Washington -- Just how long does it take to bring a new drug to market, and how much should that influence the ultimate price tag?

Although there are conflicting data, one set of researchers concluded the pharmaceutical industry's argument that long drug development times are responsible for escalating drug prices is not valid. In fact, they say, clinical trial times are not increasing but decreasing. Their study was published in the March/April Health Affairs.

"Our research shows that long development times are an unlikely factor in rising drug prices," said Salomeh Keyhani, MD, MPH, an assistant professor of health policy at Mount Sinai School of Medicine in New York. "Drug companies will price new drugs at the highest prices that the market will bear, not based on drug development times."

Dr. Keyhani and colleagues examined 168 drugs approved between 1992 and 2002 and found the median clinical trial period was 5.1 years. Trial periods did not increase during that decade.

The Pharmaceutical Research and Manufacturers of America disputes the notion that drug development time is shorter than previously thought, estimated to be as long as 10 years. And even if it were, much more is being packed into those years than ever before, said Alan Goldhammer, PhD, associate vice president for regulatory affairs at PhRMA. "More patients and more safey issues are being looked at."

The average number of patients per clinical trial has increased over the past 20 years, from 1,300 volunteer patients to 5,000, said Jeff Trewhitt, a PhRMA spokesman. The number of technical studies performed during clinical testing also has increased, from 30 to 68.

Research and development costs have been climbing steadily the past couple of decades, Trewhitt said. "In 1980, PhRMA member companies collectively spent about $2 billion on total research and development. Last year they spent an estimated $39.4 billion. The cost of research and development is not leveling off."