Published Online: Saturday, April 1, 2006

The time to develop and receive FDA approval for a drug has decreased in the past 10 years, according to a study reported in Health Affairs (March 7, 2006). The study evaluated timelines for 168 drugs approved in the United States between 1992 and 2002. The findings indicated that drugs starting development in 1985 took on average >10 years to reach the marketplace, compared with <4 years on average for drugs that began the process in 1995 or later.

Study author Salomeh Keyhani, MD, said, "One of the factors that has influenced development costs is time" in testing drugs. She added, "There's not much public data on the drug industry, but we found that drugdevelopment times are decreasing."

She noted that the study's findings illustrated that the time frame and resources for drug development vary widely, and the best-selling drugs do not take any longer to develop, compared with drugs with lower sales. A lack of public information hampers research on the factors behind drug development and pricing.

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