For cardiovascular drugs developed from 2005 to 2009, mean clinical development was 6.5 years. Only two categories of drugs took longer: antineoplastic drugs (6.9 years) and CNS drugs (8.1 years).
An analysis by Avik S. A. Roy, Senior Fellow at the Manhattan Institute for Policy Research, found that 90 percent of total development costs for approved CV, obesity and diabetes drugs were typically spent on Phase III trials.
Kenneth Kaitin with the Tufts Center for the Study of Drug Development found that for all drugs developed from 1999 to 2004, the likelihood that an agent entering Phase I would reach the market was only 16 percent. For CV drugs, the success rate fell to 7 percent.
On the medical device front, the average time for FDA review under the 510(k) procedure has risen more than 55 percent in the past seven years.