Tuesday, March 8, 2011

Report: Rise in FDA approved drugs getting supplemental use

By Michelle Lang

More drugmakers are getting their already approved drugs passed by the U.S. Food and Drug Administration for other indications. The finding was released by the Tufts Center for the Study of Drug Development (CSDD).

The Tufts CSDD Impact Report for March/April showed that FDA supplemental approvals for modified uses of drugs, other than their original intended use, increased by 17 percent, comparing the time period of 1998 to 2003 to the time period of 2004 to 2009.

The new indications for existing drugs are seen as a way to get around a slowdown on new drug approvals and approaching patent expirations, according to the study.

More results from the study showed the number of modified uses for existing drugs increased from one in 1998 to 20 in 2009, largely driven by the 107 percent growth in pediatric indication approvals. Meanwhile, the mean of the regulatory approval time for new or supplemental approvals dropped 21 percent in the same time frame, from 13.6 months to 10.8 months.