Tufts University study says FDA reviews take an average of 8 years

BOSTON Despite faster review by the Food and Drug Administration, a typical drug’s development cycle still takes eight years, according to a new report by Tufts University.

Between 2005 and 2007, the average time that the FDA took to review new drugs declined by slightly more than a year, but clinical trials take longer because the diseases that new drugs treat have become more complex, according to Tufts’ Center for the Study of Drug Development.

“Even though the total time to bring new drugs to market has remained essentially unchanged in recent years, drug developers are making progress,” Tufts CSDD director Kenneth Kaitlin said in a statement coinciding with the report, titled “Outlook 2009.” “Many factors are leading to longer clinical times, including a focus on complex diseases and more complicated development design protocols.”

Kaitlin said drug companies have taken steps to accelerate clinical development, including improving project management, expanding use of partnerships and licensing arrangements and increasing use of surrogate endpoints and adaptive clinical trials.

The report cited several near-term trends, including increasing globalization of preclinical and clinical trials to overcome local capacity constraints; continued shortages of experienced personnel, especially among upper-level management staff, hampering the FDA’s ability to fulfill its mandate; and an increase in approvals of monoclonal antibodies, or mAbs.