On occasion, they are responsible for discovering what eventually turns into a new vaccine or a new drug therapy. Between 1981 and 1990, four percent of new drugs were discovered at universities and one percent in government labs. Federal patent laws allow universities and the federal government to patent inventions that develop in their laboratories. By and large, however, innovative biomedical research companies develop new medicines, obtain FDA approval for them, and bring them to market. Companies also face increasing complexity in FDA-required research testing.
Complexity means time and time is money.
Since 1980, both the number of clinical trials for new pharmaceuticals and the number of patients in each clinical trial has doubled. As a result of this growing complexity in FDA-required testing, the total drug development time from synthesis to approval now approaches 15 years, up from an average of eight years in the 1960's. The consequences are huge. Only one in ten compounds that enter clinical testing reaches the market. Once there, new medicines have on average only 11 to 12 years of useful or effective patent life remaining to recover their research and development costs.