Study shows no change in FDA approval time

GREENVILLE, N.C., Nov. 25 (UPI) -- Scientists say the U.S. Food and Drug Administration is taking just as long as ever to approve new drugs, despite increased use of information technology.

Associate Professor John Kros and Assistant Professor Christopher Keller of East Carolina University say the FDA has implemented new information technology in an effort to reduce the time required between the submission of a new drug application, and final approval.

Although the 1992 Prescription Drug User Fee Act required drug companies to pay fees to the FDA in return for an agreement to set time limits on the review process for new drug applications, the scientists say their study found no statistically significant reduction in approval intervals from 1997 to 2006.

"The present research contributes a baseline for future comparison by which any future reductions in approval times which … result from the implementation of information technology could be verified," the researchers said.

Their findings appear in the International Journal of Electronic Healthcare.